Académique Documents
Professionnel Documents
Culture Documents
ABL800 FLEX
1. Potentiometric measuring principles
4. User-defined corrections
Reference
5. Performance specifications
manual
6. Parameters
Index
Date of Issue
System performance
The procedures described in this manual must be observed in order to ensure proper system
performance, and to avoid hazards.
Radiometer cannot provide or verify system performance characteristics if the system is not installed,
used and maintained in accordance with Radiometer procedures or if accessories not meeting the
specifications provided by Radiometer are used.
Radiometer warrants that the data media on which the software included in the system is furnished is
free from defects in material and workmanship under normal use for three (3) months from the date of
delivery as evidenced by a copy of invoice or receipt.
Confidentiality
The contents of this document shall not be reproduced or communicated to any third party without the
prior written consent of Radiometer.
Changes
This document is subject to change without notice and you are urged to contact Radiometer to verify
whether the document has been changed.
While every effort is made to ensure the correctness of the information provided in this document as
changed from time to time, Radiometer disclaims any liability for errors and omissions.
Radiometer, the Radiometer logo, ABL, AQT, TCM, RADIANCE, PICO and CLINITUBES are trademarks of
Radiometer Medical ApS.
2008 Radiometer Medical ApS. All rights reserved.
Contents
Contents ................................................................................................................1
TU UT
+
Performance test results cK ........................................................................ 5-18
P P
2+
Performance test results cCa ..................................................................... 5-24
P P
Index
T
Date of Issue
T
Contents ABL800 FLEX Reference Manual
Warnings/Cautions
T
Definitions Throughout the manual, the descriptions may contain operational precautions and
warnings.
Notice Definition
WARNING
T T
Warning alerts users to potential serious outcomes to
themselves or the patient (such as death, injury, or serious
adverse events).
PRECAUTION
T T Precaution alerts users to exercise special care necessary for
the safe and effective use of the device. Precaution may
include actions to be taken to avoid effects on patients or
users that may not be potentially life threatening or result in
serious injury, but about which the user should be aware.
Precaution may also alert users to adverse effects on the
device by use or misuse, and the care necessary to avoid such
effects.
NOTE
T T Notes give practical information.
WARNING/
T
In this manual a distinction between a warning and a caution is not made. Any
CAUTION T
notice that alerts the user to possible dangers of any kind is given the title
WARNING/CAUTION.
T T
1. Potentiometric measuring principles
Overview
Introduction This chapter describes the potentiometric measuring principles and the pH, pCO2 B B
General information
Potentiometric The potential of an electrode chain is recorded using a voltmeter, and related to the
method concentration of the sample (the Nernst equation).
An electrode chain describes an electrical circuit consisting of a sample, electrode,
reference electrode, voltmeter, membranes and electrolyte solutions.
Voltmeter
Membrane Membrane
Every element in the electrode chain contributes a voltage to the total potential
drop through the chain. Thus:
When immersed in the appropriate electrolyte solution, both electrodes have
separate potentials
The membrane junctions between the sample and electrolyte solutions also have
separate potentials
The potentiometric measuring principle is applied to pH, pCO2 and electrolyte T T B B
electrodes.
Nernst equation The complete electrode chain potential therefore is the sum of these separate
potentials and is the quantity measured by the voltmeter.
Etotal = Esample ERef
T B B B B B
where the final unknown potential (Esample) can be calculated knowing the total
T B TB
electrode chain potential (Etotal) and the reference potential (ERef is constant
T B TB T B TB
2.3RT
E sample = E 0 + log a x
nF
where:
E0 = standard electrode potential
R = gas constant (8.3143 Joule K1 mol1) P P P P
T
T T = absolute temperature (310 K (37 oC )) P P
1-2
ABL800 FLEX reference manual 1. Potentiometric measuring principles
Nernst equation
(continued)
T
n
T T = charge on the ion
F = Faraday constant (96487 coulomb mol1) P P
ax = activity of x T T
other quantities are already known. Finally the analyzer converts activity to
concentration.
Strictly speaking, the potential of an electrode chain or the magnitude of current
flowing through an electrical chain is related to the activity of a substance, and not
its concentration.
Activity expresses the "effective concentration" of a species, taking non-ideality of
the medium into account.
Activity and concentration are related by the following equation:
ax = cx
T TB B T TB B
where:
ax = the activity of the species x
T TB B
NOTE: To be exact, activity is related to the molality of species x, i.e., the number
T T
The analyzer automatically converts activities into concentrations [1]. The term
concentration is therefore used in explanations of the measuring principles for each
of the electrodes further on in this chapter.
The potentiometric measuring principle is applied in the pH, pCO2 and electrolyte B B
electrodes. It is slightly different for the pCO2 electrode, however, since the Nernst T T B B
Calibration Calibration is an analytical process defining the functional relationship between the
obtained readings or analytical responses and the concentration or other quantities
present in the calibration material (liquid or gas). Thus, a calibrating solution or a
gas mixture (for pCO2 calibrations) is drawn into the measuring chamber and the
B B
analyzer adjusts itself to measure the known value of the liquid or gas.
1-3
1. Potentiometric measuring principles ABL800 FLEX reference manual
Calibration The electrodes are active elements and must be calibrated regularly. Signals from
(continued) the electrodes change because of, e.g., protein build-up, worn-out membranes,
aging electrodes, etc.
T T
The responses from the electrodes when measuring on the calibrating solutions are
checked to ensure that the amplified signals from the electrodes are converted to
accurate values for an unknown sample. The relationship between the electrode
amplifiers output and the pH/pCO2 /electrolyte electrodes are simple mathematical
B B
Calibration line The calibration line expresses the relationship between the potential measured at
an electrode, and the concentration of the species specific to the electrode. The
calibration line forms the basis of the scale used by the analyzer to convert
electrode chain potentials to concentrations. Each electrode has a different
calibration line.
The pH electrode is used as an example to illustrate how the calibration line is
derived from two calibration solutions with known pH.
The calibration solutions give the following two points: 64 mV at pH 6.802 (Cal T T
Within the coverage range 6.300 to 8.000 the pH electrode is linear, and the
relationship between potential and pH is linear, so a line can be drawn between the
two points, as shown below:
Measured
potential This is a 2-point calibration.
(mV) 64 In 1-point calibration, only
the position of the calibration
Calibration line line is determined. The slope
97 of the calibration line is
100
maintained from the last 2-
point calibration.
pH
6.802 7.346 7.398
pH of Cal 2 sol. pH of sample pH of Cal 1 sol.
The calibration line is stored in the computer and is used during measurement to
convert the potential measured at the pH electrode during sample analysis to an
actual pH value.
1-4
ABL800 FLEX reference manual 1. Potentiometric measuring principles
Calibration line To describe the actual condition of the electrode, its calibration line is compared to
(continued)
T T the calibration line of the theoretical electrode.
Measured
potential The theoretical electrode is
(mV) 75.5
defined to measure the
following:
Theoretical calibration line
112.4 mV at pH 7.400,
112.4 75.5 mV at pH 6.800.
pH
6.8 7.4
The position and slope of the calibration line compared to the theoretical
calibration line are described by the status and sensitivity.
Sensitivity The electrode sensitivity illustrates the slope of the calibration line compared to the
slope of the theoretical electrode.
The sensitivity of the theoretical electrode is 100 % or 1.00.
Measured
potential
If an electrode
has a sensitivity
2-point calibration line
(mV) 75.5
Slope = 58.4 mV/pH
Sensitivity = 95 % of 95 % or 0.95,
its sensitivity is
Theoretical calibration line 5 % lower than
Slope= 61.5 mV/pH
112.4
Sensitivity = 100 % the theoretical
electrode.
pH
6.8 7.4
1-5
1. Potentiometric measuring principles ABL800 FLEX reference manual
Status Status reflects the deviation from the theoretical electrode at pH 7.400 and,
therefore, indicates the position of the calibration line.
The calibration line for the actual electrode deviates from that of the theoretical
electrode. The status value describes this deviation.
Status of the actual pH electrode at pH 7.400 is calculated as:
Meas. potential at 7.400 Potential of theoretical electr. at 7.400
Status = 7.400
61.5 100
The obtained drift values should not exceed the calibration drift tolerances. The
drift tolerances can be changed in the Setup program, but Radiometer recommends
using the default drift tolerances. Too narrow drift tolerances will cause electrode
drift errors even for normal electrode fluctuations. If the drift tolerances are made
wider, no warning will be given if the electrodes should become unstable.
Significant measurement errors could result.
1-6
ABL800 FLEX reference manual 1. Potentiometric measuring principles
Measuring time The measuring time of the electrode is independent of the electrode type. Electrode
signals are registered at 0.982-second intervals during both calibrations and
measurements. The registration of each electrode signal begins after the samples,
calibration solutions and calibration gases are in position in the measuring
modules. The duration of each calibration is predetermined, as is the number of
updatings of the electrodes signals.
Updatings In general, the updatings from an electrode response are numbered from 1 to upd. T
last, where updating number 1 is the first updating and upd.last is the last. The
T T T
Signal
Updatings
1-7
1. Potentiometric measuring principles ABL800 FLEX reference manual
Reference electrode
Ag+ + e Ag
T P P P P T
These reactions are possible because the electrode is made from a Ag rod coated
with AgCl to provide the Ag/Ag+ equilibrium and determine the reference
P P
potential.
Membrane Function
Inner To limit diffusion through the membrane and stabilize the whole
membrane system.
Middle To prevent protein interference.
Outer To reduce the interchange of sample or Rinse Solution and
HCOONa solution.
Packaging The E1001 reference electrode comes in a box with an insert explaining the
preparation of the electrode and its use.
1-8
ABL800 FLEX reference manual 1. Potentiometric measuring principles
pH electrode
Description The pH electrode (E777) is a pH-sensitive glass electrode. The pH-sensitive glass
membrane is located at the tip and seals the inner buffer solution with a constant
and known pH.
The air bubble allows for expansion
Electrode contact of the inner buffer solution when the
electrode is thermostatted to 37 oC.P P
Inner buffer
are exchanged with protons on either
solution side of the membrane, from the inner
buffer solution on one side and the
sample on the other.
Glass membrane
A difference in the ion exchange on either side of the membrane occurs if the H+ P P
concentration (and therefore pH) is unequal on both sides. The number of positive
and negative ions is no longer equal, so the potential difference across the
membrane changes. If the H+ concentrations on either side of the membrane are
P P
Nernst equation The theoretical sensitivity of the pH electrode at 37 oC being equal to 61.5 mV
P P
per pH unit, using pH = log [H+], and converting concentration to activity, the
P P
1-9
1. Potentiometric measuring principles ABL800 FLEX reference manual
pH electrode, Continued T T
Designation
pH(Cal1,nom) = Nominal pH of Cal 1 solution (pH = 7.4)
(continued)
T
Sensitivity The sensitivity of the pH electrode (SenspH) is obtained from the calibration line
B B
obtained from a 2-point calibration on Calibration Solutions 1 and 2 (Cal 1 and Cal
2), and is calculated from the following equation:
E(pH, Cal2) E(pH, Cal1)
Sens(pH) = (fraction)
61.5 [pH(Cal2) pH(Cal1)]
The sensitivity of the pH electrode should fall between 0.92-1.03 or 92-103 %.
Status The status of the pH electrode is calculated from the following equation:
E(pH, Cal1) E 0 (pH, Cal1)
Status(pH) = + 2 pH(Cal1, nom) pH(Cal1)
- 61.5
The status of the pH electrode should fall between a pH of 6.7 and 8.1.
instances where the Cal 1 solution container has been replaced between two
consecutive calibrations, pH(Cal1) pH(Cal1,prev) 0.
T T T
The default drift tolerances set by Radiometer for Drift 1 are 0.020.
The default drift tolerances set by Radiometer for Drift 2 are 0.020.
1-10
ABL800 FLEX reference manual 1. Potentiometric measuring principles
pH electrode, Continued T T
Corrections The measured pH value is then corrected for systematic deviations from the
reference method using the following equation:
Equation A:
T T
pH(sample,corr.) = A0 pH(sample) + A1
B B B B
where:
pH(sample) = uncorrected pH value of the sample
pH(sample,corr.) = corrected pH value of the sample.
A0 B B = instrument-dependent correction factor
A1 B B = instrument-dependent cut-off
Equation A+:
T
When an additional correction is needed, equation A is first used together with the
constants for the macromode S250 and FLEXMODE (195 and 165 L, no
message) mode. Then the obtained results are put back into equation A as
pH(sample) and then treated again, using the constants for the specific sample
handling to obtain the corrected value.
Corrections are as follows:
ABL8xx
T Mode
T T T A0
B TB T A1
B TB Equation
T T
FLEX T
1-11
1. Potentiometric measuring principles ABL800 FLEX reference manual
pH electrode, ContinuedT T
Corrections
(continued)
T
ABL8xx Mode A0B B A1
B B Equation
FLEX
35/25/15 S195 0.9964 0.0150 A
S95 0.9964 0.0150 A
S85 0.9964 0.0150 A
C95 1.007 0.053 A+
C55 1.025 0.1880 A+
FLEXMODE (no message) 0,9964 0.0150 A
FLEXMODE (message 897) 1.007 0.0530 A+
FLEXMODE (message 895) 1.007 0.0530 A+
FLEXMODE (message 894) 1.007 0.0530 A+
FLEXMODE (message 873) 1.007 0.0530 A+
FLEXMODE (message 872) 1.0216 0.1639 A+
FLEXMODE (message 871) 1.025 0.1880 A+
FLEXMODE (message 870) 1.030 0.216 A+
FLEXMODE (message 869) 1.030 0.216 A+
30/20/10 S85 0,9964 0.0150 A
10 BG C55 1.025 0.1880 A+
only
FLEX FLEXMODE (no message) 1.0006 0.0035 A+
FLEXMODE (message 872) 1.0209 0.1575 A+
FLEXMODE (message 871) 1.025 0.1880 A+
FLEXMODE (message 870) 1.030 0.216 A+
FLEXMODE (message 869) 1.030 0.216 A+
1-12
ABL800 FLEX reference manual 1. Potentiometric measuring principles
pH electrode, Continued
T T
Corrections
(continued)
T
ABL8xx Mode A0
B B A1B B Equation
FLEX
05 S165 0,9964 0.0150 A
S95 0,9964 0.0150 A
S85 0,9964 0.0150 A
C95 1.007 0.053 A+
C55 1.025 0.1880 A+
FLEXMODE (no message) 0,9964 0.0150 A
FLEXMODE (message 897) 1.007 0.053 A+
FLEXMODE (message 895) 1.007 0.053 A+
FLEXMODE (message 894) 1.007 0.053 A+
FLEXMODE (message 873) 1.007 0.053 A+
FLEXMODE (message 872) 1.0216 0.1639 A+
FLEXMODE (message 871) 1.025 0.1880 A+
FLEXMODE (message 870) 1.030 0.216 A+
FLEXMODE (message 869) 1.030 0.216 A+
00 BASIC S195 0.9964 0.0150 A
S95 0.9964 0.0150 A
S85 0.9964 0.0150 A
C95 1.007 0.053 A+
C55 1.025 0.1880 A+
1-13
1. Potentiometric measuring principles ABL800 FLEX reference manual
pH electrode, Continued T T
Stability criteria The following stability criterion must be met to obtain a stable electrode response
during 1- and 2-point calibrations:
T T
The following stability criterion must be met to obtain a stable electrode response
during measurement:
T T
where:
1-14
ABL800 FLEX reference manual 1. Potentiometric measuring principles
pCO2 electrode
T T B B
Description The pCO2 electrode (E788) is a combined pH and Ag/AgCl reference electrode
B B
Membrane
The membrane allows any uncharged molecules of CO2, O2 and N2 to pass through B B B B B B
it. Charged ions such as H+ will not pass. Consequently, dissolved CO2 from the
P P B B
sample will diffuse into the thin layer of bicarbonate electrolyte until the
equilibrium is reached.
This produces carbonic acid:
H2O + CO2 H2CO3
B B B B B B B
the potential difference across the glass membrane. This change in potential across
the glass membrane is measured by the voltmeter.
Nernst equation The Nernst equation is used to convert the potential reading into a pH value:
E glass = E 0 61.5 pH (mV)
where:
Eglass
T TB B = potential difference across the glass membrane
E0
T TB B = standard electrode potential
61.5 mV/pH = theoretical sensitivity of the pH electrode at 37 oC P P
1-15
1. Potentiometric measuring principles ABL800 FLEX reference manual
Nernst equation The pH value is related to the partial pressure of CO2 in the sample by the B B
(continued)
T following equation:
T
cHCO 3-
pH = pK a + log
pCO 2 CO 2
where:
pK a = log Ka, the equilibrium constant for the dissociation of carbonic acid in
B B
water
CO 2 = solubility coefficient for CO2 in water B B
cH + cHCO 3
Ka = is the equilibrium constant for carbonic acid.
CO 2
pCO2 of the sample is then calculated from the equation above.
B B
pCO2(Gas2)
T T B B
FCO2(Gas1),
T T B B T =
T T Fraction of CO2 in Gas 1 or Gas 2, respectively
B B T
FCO2(Gas2)
T T B B T
BGas 1 or 2
T TB B
E(CO2,Gas1), B B
B B
at 37 oCP P
Sens(pCO2,prev) B B
1-16
ABL800 FLEX reference manual 1. Potentiometric measuring principles
Designation
E0(CO2,Gas1) = Standard potential of the pCO2 electrode with Gas 1
(continued)
B B B B
B B
E(CO2,Gas1,prev)
B B
measurement on Gas 1
= Difference between pCO2 (sample) from the first and
T T B B
last updatings
predict = Extrapolated value for pCO2 T T B B
Sensitivity The pCO2 electrode is calibrated on two gases with known CO2 contents:
B B B B
equations:
pCO 2 (Gas1) = FCO 2 (Gas1) ( BGas 1 pH 2 O) kPa
pCO 2 (Gas2) = FCO 2 (Gas2) ( BGas 2 pH 2 O) kPa
or 85-100 %.
The status of the pCO2 electrode should fall between 6.2-260 mmHg (0.83-34.66 kPa).
B B
1-17
1. Potentiometric measuring principles ABL800 FLEX reference manual
Drift (continued) The default drift tolerances set by Radiometer are as follows:
T T
Measurement The pCO2 value for a sample is calculated from the following equations:
T T B B
predict =
pCO 2 (sample, upd6) + pCO 2 (sample, upd30) 2 pCO 2 (sample, upd18)
Corrections The pCO2 measured on a sample is then corrected for systematic deviations from
T T B B
+ A0 pCO2(sample) + A1 (B pH2O) B B T T B B B B T T T T B B
A0 B B = correction factor
A1 B B = correction factor
A2 B B = correction factor
A3 B B = correction factor
pH2O
T T B B = partial pressure of saturated water vapor (6.2751
kPa)
and
1-18
ABL800 FLEX reference manual 1. Potentiometric measuring principles
Corrections Equation B:
T T
(continued)
T T
ABL8xx
T T Mode T A0
T B TB T A1 B TB A2
T B TB A3
T B TB B0
T B TB T B1
B TB Eq.
T T
FLEX T
1-19
1. Potentiometric measuring principles ABL800 FLEX reference manual
Corrections
blood samples
(continued)
T
ABL8xx
T T Mode T A0
T B TB A1
T B TB A2
T B TB A3
T B TB T B0
B TB B1
T B TB T Eq.
T
FLEXT
1-20
ABL800 FLEX reference manual 1. Potentiometric measuring principles
Corrections The pCO2 measured from the sample is then corrected for systematic deviations
B B
expired air from the reference method using the following equation:
samples pCO 2 (sample, corr) = A 0 pCO 2 (sample) + A 1 ( B pH 2 O) Equation A: T T
where:
pCO2(sample)
T T B B = uncorrected pCO2 value of an expired air sample
T T B B
A0 B B
= instrument-dependent correction factor
A1 B B
= instrument-dependent correction factor
B
T T
= barometric pressure during the measurement
pH2O
T T B B
= partial pressure of saturated water vapour = 6.2751 kPa
ABL8xx
T T
Mode
T T T A0 B TB A1
T B TB T Equation T
Stability criteria The following stability criterion must be met to obtain a stable electrode response
during calibration:
This criterion is valid for calibrations using Gas 1 and Gas 2 where:
ABL8x5/8x7 FLEX
T T ABL8x0 FLEX
T T
pCO2(sample,upd.last) B B 92 62
pCO2(sample,upd.i) B B 86 or 87 56 or 57
(the relationship must be fulfilled for at least one of
the updating numbers)
pCO2(limit) value for the stability criterion is 0.40 kPa (3.0 mmHg).
T T B B
1-21
1. Potentiometric measuring principles ABL800 FLEX reference manual
Stability criteria The following stability criteria must be met to obtain a stable electrode response
(continued)
T T during measurement:
= pCO 2 (sample, upd.30) pCO 2 (sample, upd.i)
For Criterion
1.33 kPa pCO 2 (sample, upd.30) pCO 2 (sample, upd.16) 0.40
>1.33 kPa 0.1
pCO 2 (sample, upd.30) pCO 2 (sample, upd.16 )
< 0.5
pCO 2 (sample, upd.16 ) pCO 2 (sample, upd.1)
or
pCO2 (sample,upd.30) pCO2 (sample,upd.24)0.04 pCO2 (sample,upd.30).
B B B B B B
1-22
ABL800 FLEX reference manual 1. Potentiometric measuring principles
Electrolyte electrodes
1-23
1. Potentiometric measuring principles ABL800 FLEX reference manual
Description T
Electrode contact The Ca electrode (E733) is an ion-
(continued) T selective electrode whose sensing
element is a PVC membrane containing
a calcium-neutral ion carrier. The ion-
sensitive membrane is covered with a
cellophane membrane in order to
Electrode jacket protect it from the samples.
The electrolyte has a constant and
known concentration of calcium ions.
When a sample is brought in contact
with the electrode, a potential develops
across the PVC and cellophane
membranes. The potential depends on
the difference between the calcium
(more precisely, activity) in the
Cellophane membrane
electrolyte and the sample. If the cCa2+ P P
1-24
ABL800 FLEX reference manual 1. Potentiometric measuring principles
Electrode chain The total potential across the electrode chain is a sum of the potential differences at
potential each of the elements in the chain, all but one of which is known and constant.
The unknown potential difference across the ion-sensitive membrane or pin is then
the difference between the measured total potential and the sum of the known
potentials:
ESample = E tot ( E ref + EMJ + E E ) mV
Nernst equation The potential difference at the membrane (or pin) in the electrolyte electrodes can
be expressed by the Nernst equation:
2.3RT
E Sample = E 0 + log a ion mV
nF
where:
E0 = standard electrode potential
R = gas constant (8.3143 J K1mol1) P P P P
T
T T = absolute temperature (310.15 K at 37 oC) P P
n
T T = charge on the ion (n = 1 for K and Na , n = 1 for Cl, n = 2 for Ca2+)
+
P P
+
P P P P P P
1-25
1. Potentiometric measuring principles ABL800 FLEX reference manual
Calibration Calibration solutions for the ABL835/30/25/20/15/10/05 FLEX analyzers have the
solution values following nominal electrolyte concentrations:
Parameter S1820 Cal 1 S1830 Cal 2
+
cK
T T P P 4.0 mmol/L 40.0 mmol/L
+
cNa
T T P P 145 mmol/L 20.0 mmol/L
cCa2+
T T P P 1.25 mmol/L 5.0 mmol/L
cCl
T T P P 102 mmol/L 50 mmol/L
Calibration solutions for the ABL837/27/17 FLEX analyzers have the following
nominal electrolyte concentrations:
Parameter S1827 Cal 1 S1837 Cal 2
cK+
T T P P 4.0 mmol/L 10.0 mmol/L
+
cNa
T T P P 145 mmol/L 50.0 mmol/L
2+
cCa
T T P P 1.25 mmol/L 5.0 mmol/L
cCl
T T P P 102 mmol/L 50 mmol/L
cX(Cal1)
T T = Concentration of the respective electrolyte ion in
Cal 1 solution
cX(Cal2)
T T = Concentration of the respective electrolyte ion in
Cal 2 solution
E0(X,Cal1)
B B = Standard potential of the respective electrolyte
electrode chain
1-26
ABL800 FLEX reference manual 1. Potentiometric measuring principles
Designations
cX(Cal1,nom) = Nominal concentration of the respective electrolyte
(continued)
T T
Sensitivity The sensitivity of the electrolyte electrodes is calculated from the following
equations:
K electrode
E(K, Cal1) E(K, Cal2)
Sens(K)= (fraction)
cK + (Cal1)
61.5 log
cK + (Cal2)
Na electrode
E(Na, Cal1) E(Na, Cal2)
Sens(Na)= (fraction)
cNa + (Cal1)
61.5 log
cNa + (Cal2)
Ca electrode
E(Ca, Cal1) E(Ca, Cal2)
Sens(Ca)= (fraction)
cCa 2 + (Cal1)
30.75 log
cCa 2 + (Cal2)
Cl electrode
E(Cl, Cal1) E(Cl, Cal2)
Sens(Cl)= (fraction)
cCl (Cal1)
- 61.5 log
cCl (Cal2)
1-27
1. Potentiometric measuring principles ABL800 FLEX reference manual
Status The status of each of the electrolyte electrodes is calculated from the following
equations:
K electrode
E(K,Cal1) E 0 (K,Cal1)
10 61.5 cK + (Cal1, nom) 2
Status(K) = mmol/L
cK + (Cal1)
Na electrode
E(Na,Cal1) E 0 (Na,Cal1)
10 61.5 cNa + (Cal1, nom) 2
Status(Na) = mmol/L
cNa + (Cal1)
Ca electrode
E(Ca,Cal1) E 0 (Ca,Cal1)
10 30.75 cCa 2 + (Cal1, nom) 2
Status(Ca) = mmol/L
cCa 2 + (Cal1)
Cl electrode
E(Cl,Cal1) E 0 (Cl,Cal1)
10 -61.5 cCl (Cal1, nom) 2
Status(Cl) = mmol/L
cCl (Cal1)
1-28
ABL800 FLEX reference manual 1. Potentiometric measuring principles
E(Na,Cal1) E(Na,Cal1,prev)
Ca electrode
E(Ca,Cal1) E(Ca,Cal1,prev)
Cl electrode
E(Cl,Cal1) E(Cl,Cal1,prev)
NOTE: If Cal 1 solution bottle has not been changed between two consecutive
calibrations, the cX(Cal1,prev) cX(Cal1) = 0, where X is the respective
T T T T
electrolyte ion. T T
where:
E(X,sample) = potential of the electrolyte electrode chain from a
measurement on the sample.
E(X,Cal,prev) = potential of the electrolyte electrode chain from the
previous calibration on Cal 1 solution.
cX(Cal 1) =
T T B B
specific (true) concentration of the electrolyte ion in Cal 1
solution.
1-29
1. Potentiometric measuring principles ABL800 FLEX reference manual
Measurement
Sens(theo) = theoretical sensitivity of the electrolyte electrode.
(continued)
Sens(X,prev) = relative sensitivity of the electrolyte electrode chain from
T
Corrections The measured electrolyte concentration is then corrected for systematic deviations
from the reference method by the following equations:
Equation A:
T
and
Equation B:
T T
where
cX(sample)
T T = uncorrected value of the electrolyte ion in the sample
cX(sample,corr) = corrected value of the electrolyte ion in the sample
T T
Chloride is corrected for cHCO 3 interference. The default value cHCO 3 = 24.5
mmol/L is used in
Equation C:
T
+A1,macromode B B
Note that subscript "macromode" in the equations above is used for the sake of
convenience and stands for S250, "FLEXMODE (no message)".
1-30
ABL800 FLEX reference manual 1. Potentiometric measuring principles
(continued)
T T
ABL8xx
T Mode
T T T A0
B TB T A1
B TB Equation
T T
FLEX T
1-31
1. Potentiometric measuring principles ABL800 FLEX reference manual
(continued)
T T
ABL8xx
T T Mode T T A0
B TB A1
T B TB T Equation T
FLEX T
*FM = FLEXMODE
1-32
ABL800 FLEX reference manual 1. Potentiometric measuring principles
(continued)
T T
ABL8xx
T T Mode T A0
T B TB A1
T B TB T Equation T
FLEX T
1-33
1. Potentiometric measuring principles ABL800 FLEX reference manual
ABL8xx
T T Mode T A0
T B TB A1
T B TB T Equation T
FLEX T
1-34
ABL800 FLEX reference manual 1. Potentiometric measuring principles
Stability criteria The following stability criterion must be met to obtain a stable electrode response
during calibration:
This criterion is valid for calibrations using Cal 1 and Cal 2 solutions where:
cX(Cal,upd.last) =
T T Concentration of the electrolyte ion from the last updating
when measuring on calibration solution. (The last
updating is number 30.)
cX(Cal,upd.i) =
T T Concentration of the electrolyte ion for a given updating
when measuring on calibration solution. (The relationship
must be fulfilled for at least one of the updating numbers
18 or 19.)
K= Constant for the stability criterion.
Electrolyte ion
T T Cal 1 solution
T T T Cal 2 solution T
K+ P P 0.01 0.01
Na+ P P 0.01 0.02
2+
Ca P P 0.02 0.02
Cl P P 0.022 0.022
The following stability criterion must be met to obtain a stable electrode response
during measurement:
where:
cX(sample,upd.last) =
T T Concentration of the electrolyte ion from the median
of the last five updatings (for Ca2+: Three last P P
22 22 26 22
23 23 27 23
In some micromodes, substract 20 from number
above.
1-35
1. Potentiometric measuring principles ABL800 FLEX reference manual
Stability criteria
K Constant for the stability criterion; it equals to:
(continued)
T
1-36
ABL800 FLEX reference manual 1. Potentiometric measuring principles
References
1-37
1. Potentiometric measuring principles ABL800 FLEX reference manual
1-38
2. Amperometric measuring principles
Overview
Introduction This chapter describes the amperometric measuring principles and the pO2, B B
Glucose, Lactate and Crea electrodes that are based on this principle.
pO2 electrode....................................................................................................
B B 2-4
X X
General information
Amperometric The magnitude of an electrical current flowing through an electrode chain, which
method is in turn proportional to the concentration of the substance being oxidized or
reduced at an electrode in the chain
The electrode chain in amperometric measurements consists of the sample, the two
electrodes (anode and cathode), an ammeter, a voltage source, the membranes and
the electrolyte solutions.
Ammeter
Applied voltage
Anode Cathode
Electrolyte solution
Membrane
Sample
Part Function
Cathode Negative electrode where a reduction reaction occurs and
electrons are consumed.
Anode Positive electrode where an oxidation reaction occurs and
electrons are released.
Electrolyte Provides electrical contact between the anode and cathode.
solution
Membrane Allows the appropriate molecules to pass through from the
sample.
Sample Contacts the membrane.
Applied voltage Applies the necessary potential for the reduction or oxidation
reaction under study.
Ammeter Measures the current flowing through the circuit.
2-2
ABL800 FLEX reference manual 2. Amperometric measuring principles
Amperometric The membrane is selective to the species A, allowing no other species but it to pass
T T
T T
reaction:
X X+ + e P P P
The magnitude of the current flowing through the circuit is proportional to the
concentration of the species being reduced, in this case species A. The analyzer T T
Calibration The electrodes are active elements and must be calibrated regularly as the signals
from the electrodes change with, e.g. age or deposits on the membrane.
Calibration relates the electrode signals during the calibration sequence to the
values of the calibrating solutions and must be performed at regular intervals so
that the accuracy can be constantly refined after inevitable minor changes in the
electrodes behavior.
Actual electrode condition is described by zero point and sensitivity and compared
with theoretical conditions for an "ideal" electrode. In addition to zero point and
sensitivity, an electrode condition is described by drift.
2-3
2. Amperometric measuring principles ABL800 FLEX reference manual
pO2 electrode
T T B B
Description The pO2 electrode is an amperometric electrode which consists of a silver anode,
B B
platinum cathode and Ag/AgCl reference band, all protected by an electrode jacket
which is filled with electrolyte solution. At the tip of the electrode jacket an
oxygen-permeable membrane protects the Pt cathode from protein contamination
and is covered on the inner side with Pt-black.
Electrode contact
The electrode chain is polarized
with a constant voltage of -630
mV.
Oxygen from the sample diffuses
across the membrane into the
electrolyte and is reduced on the
Electrode jacket cathode (electrons are consumed)
according to the following
equation:
Electrolyte O2 + 4H+ + 4e 2H2O B B P P P P B B
electrolyte solution.
This represents the complete
reduction of O2. Some of the O2, B B B B
This oxygen is then also reduced at the cathode. The reduction of oxygen produces
a flow of electrons (an electrical current) the size of this current, I, proportional to
the amount of oxygen and measured by the ammeter:
I = Sens(pO2) pO2 + Io pA T T B B B B T TB B
where:
Io
T TB B = zero current, i.e. the current flowing through the circuit when
pO2 = 0 kPa (mmHg)
B B
Ag Ag+ + e P P P P
In order to maintain a charge balance between the anode and cathode, four atoms
of Ag need to be oxidized for one molecule of O2 to be reduced. B B
2-4
ABL800 FLEX reference manual 2. Amperometric measuring principles
Description The Ag+ ions are released into the electrolyte solution where they react with the
P P
(continued)
T
Cl ions present, producing AgCl which is insoluble and forms a layer on the silver
P P
rod:
Ag+ + Cl AgCl
P P P P
Not all Ag+ ions can be removed from the solution. Some reach the cathode where
they are converted back to Ag and form a deposit of silver. This deposit must be
periodically removed with the brush provided in the electrode box.
Designations The following designations are used to describe sensitivity, zero point and drift:
I(O2,Gas1) B B
Gas 1
I(O2,Gas2) B B
Gas 2
pO2(Gas1)B B
pO2(Gas2)B B
FO2 (Gas1)
T T B B = Fraction of O2 in Gas 1
B B
FO2 (Gas2)
T T B B = Fraction of O2 in Gas 2
B B
B
T T
= Ambient pressure
pH 2 O = Water vapor pressure = 6.2571 kPa at 37 oC. P P
Sens(pO2, B B
point calibration
I(O2,Gas2, B B
measurement on Gas 2
Sensitivity The pO2 electrode is calibrated on two gases with known O2 content.
B B B B
2-5
2. Amperometric measuring principles ABL800 FLEX reference manual
Sensitivity The partial pressures of O2 in the gas mixtures Gas 1 and Gas 2 are calculated from
B B
(continued)
T T the following equation:
pO 2 (gas1) = FO 2 (Gas1) [B pH 2 O] kPa
pO 2 (gas2) = FO 2 (Gas2) [B pH 2 O] kPa
The sensitivity of the pO2 electrode should fall between 5-40 pA/mmHg or 37.5-
B B
300 pA/kPa.
Zero point The zero point of the pO2 electrode is the electrode current at pO2 = 0. It is
B B B B
calculated from the current measured at the electrode with Gas 2 (0 % O2), and the B B
sensitivity:
I(O 2 , Gas2)
Zero point(pO 2 )= kPa
Sens( pO 2 , prev)
The zero point value of the pO2 electrode should be less than 6.0 mmHg or 0.80 kPa.
B B
The zero point current is the current measured at the pO2 electrode with Gas 2 in B B
the measuring chamber. When the measurement on Gas 2 begins, a relatively high
current is recorded due to residual O2 from the Rinse Solution in the measuring
B B
chamber. This current falls exponentially with time while Gas 2 is present in the
measuring chamber.
Time (secs)
2-6
ABL800 FLEX reference manual 2. Amperometric measuring principles
Measurement The pO2 value for a sample is calculated from the following equations:
T T B B
measurement on Gas 2
Sens(pO2) = B B relative sensitivity of the pO2 electrode determined T T B B
updatings
predict = extrapolated value for pO2 T T B B
pO2(sample) = predict T T B B
2-7
2. Amperometric measuring principles ABL800 FLEX reference manual
blood samples
K1 is a constant that describes the gas/liquid relationship for the electrode. The
B B
1 Sens( pO 2 )
K1 = 1 + 5.8370 + 21.712 +
100 3.66294
The pO2 measured from the sample is then corrected for systematic deviations
T T B B
pO 2 (sample,corr) =
(
d 1 + d 12 4 e2 + e3 pO 2 (sample, v1) + e4 pO 2 (sample, v1) 2 )
2
where:
pO2 value of the sample after the first part of correction is as follows:
T T B B
4
pO 2 (sample, v1) = pO 2 (sample) + (k1 k 2 e k3 pO 2 (sample) ) (100.398 B)
and:
d1 B B
= e0 pO2(sample, v1) + e1
B B T T B B B B
k1
T TB B
= correction constant = 0.02614
k2
T TB B
= correction constant = 0.02107
k3
T TB B = correction constant = 0.00281
e0, e1, e2, e3, e4
B B B B B B B B B B
= correction constants
B = barometric pressure in kPa
Equation A+:
T
When an additional correction is needed, equation A is first used together with the
constants for the macoromodes S250 and FLEXMODE (C195 and 165) with no
message. Then the obtained results are put back into equation A as pO2(sample) B B
and then treated again, using the constants for the specific mode.
Or
Equation B:
T
When an additional correction is needed, equation A is first used together with the
constants for the macoromodes S250 and FLEXMODE (C195 and 165) with no
message. Then the obtained results are put back into equation B as pO2(sample) B B
and then treated again, using the constants for the specific mode.
cX(sample,corr) = A0 cX(sample) + A1
T T B B T T B B
2-8
ABL800 FLEX reference manual 2. Amperometric measuring principles
Corrections
blood samples
(continued)
T T
TABL Mode
T T e0
B B e1
B B e2
B B e3
B B e4
B B A0B B A1B B Eq.
8xx
FLEX T
2-9
2. Amperometric measuring principles ABL800 FLEX reference manual
Corrections
blood samples
T(continued)T
(continued)
T
ABL Mode e0
B B e1
B B e2
B B e3
B B e4
B B A0
B B A1B B Eq.
8xx
FLEX
05 S165 -2.30300 5.96942 0.83281 -6.07310 1.30565 A
S95 1.020 -0.200 A, B
S85 -2.30300 5.96942 0.83281 -6.07310 1.30565 A
C95 0.9965 -0.0254 A, B
C55 -2.1199 4.7210 -1.0156 -4.2974 1.1035 A, A+
*FM (no message) -2.30300 5.96942 0.83281 -6.07310 1.30565 A
*FM (message 897) 0.9965 -0.0254 A, B
*FM (message 895) 0.9965 -0.0254 A, B
*FM (message 894) 0.9965 -0.0254 A, B
*FM (message 873) 0.9965 -0.0254 A, B
*FM (message 872) -2.20159 5.70807 -0.41342 -5.42718 1.19023 A, A+
*FM (message 871) -2.1199 4.7210 -1.0156 -4.2974 1.1035 A, A+
00 S195 -2.30300 5.96942 0.83281 -6.07310 1.30565 A
BASIC S95 1.020 -0.200 B
S85 -2.30300 5.96942 0.83281 -6.07310 1.30565 A
C95 0.9965 -0.0254 B
C55 -2.1199 4.7210 -1.0156 -4.2974 1.1035 A+
*FM = FLEXMODE
2-10
ABL800 FLEX reference manual 2. Amperometric measuring principles
Corrections The pO2 measured from the sample is then corrected for systematic deviations
T T B B
expired air from the reference method using the following equation:
samples
pO 2 (sample, corr) = A 0 pO 2 (sample) + A 1 ( B pH 2 O)
where:
pO2(sample)
T T B B = uncorrected pO2 value of an expired air sample
T T B B
pO2(sample,corr)
T T B B = corrected pO2 value of an expired air sample
T T B B
A0 B B
= instrument-dependent correction factor
A1 B B
= instrument-dependent correction factor
B
T T
= barometric pressure during the measurement
pH2O
T T B B
= partial pressure of saturated water vapour = 6.2571 kPa
ABL8xx FLEX
T T Mode
T T A0
T B TB A1
T B TB T Equation
T
Stability criteria The following stability criterion must be met to obtain a stable electrode response
during calibration: T T
This criterion is valid for 1-point calibrations (Gas 2 contains no oxygen) where:
2-11
2. Amperometric measuring principles ABL800 FLEX reference manual
Stability criteria
(continued)
T T
Parameter pO2 value from the last updating number...
B B
pO2(Gas1,upd.last)
B B 92 62
pO2(Gas1,upd.i)
B B 86 or 87 56 or 57
(the relationship must be fulfilled for at least one of
the updating numbers)
The following stability criteria must be met in order to obtain a stable electrode
response during measurement: T T
=|pO2(sample,upd.30) pO2(sample,upd.1)|
B B B B
For Criterion
2.66 kPa pO 2 (sample) pO 2 (sample, upd.16) 0.80
or
pO2 (sample,upd30) pO2 (sample,upd.24)0.05 pO2 (sample,upd.30).
B B B B B B
2-12
ABL800 FLEX reference manual 2. Amperometric measuring principles
Electrolyte
O2 for this reaction is supplied by the
B B
2-13
2. Amperometric measuring principles ABL800 FLEX reference manual
Description
(continued)
T T
H2O2 2H+ + O2 + 2e
B B B B P P B B P P
In order to maintain a charge balance between the anode and the cathode, two Ag+ P P
Zero current The zero current is a small background current measured at the electrode when no
glucose or lactate is present in a solution. As the Rinse Solution contains no
glucose or lactate, a baseline representing the zero current, I0 as a function of time B B
I
(current)
Extrapolated
Rinse x x xx x x x x x baseline
x x x x
I0(t)
I0(t)
tmean Time
tfinal
N measurements of I0
on the Rinse Solution
At the end of a rinse, with the Rinse Solution in the measuring chamber, zero
current of the metabolite electrodes is measured periodically (the intervals
between these measurements become longer if the analyzer is idle)
The previous N (N = 8) measurements on the Rinse Solution before a calibration
or a sample measurement starts are used to obtain a baseline representing the time
function of I0 B B
2-14
ABL800 FLEX reference manual 2. Amperometric measuring principles
Zero current The baseline is extrapolated thoughout the whole electrode calibration or sample
(continued)
T T
measurement period, and represents the zero current time function
The I0 baseline is used to determine the sensitivity of the metabolite electrode
B B
The extrapolated final zero current value at the metabolite electrodes at the last
updating (illustrated by the I0 baseline) is determined as follows: B B
t n =1
n
t mean = sec
N
where tn is the time of the nth measurement on the rinse solution.
B B P P
I0(mean)
B B = the zero current at the mean time (tmean): B B
I
n =1
0, n
I 0 (mean) = pA
N
where I0,n is the zero current at the nth measurement on the rinse
B B P P
solution
Islope
B B = the slope or gradient of the I0 baseline B B
(t
n =1
n t mean )
The zero current of the metabolite electrodes should be less than 10,000 pA.
2-15
2. Amperometric measuring principles ABL800 FLEX reference manual
Sensitivity The sensitivities of the metabolite electrodes are calculated by measuring the
current on Calibration Solution 1 (Cal 1) and then correcting for the zero current
using the extrapolated I0 baseline. B B
I
I(Cal 1,upd.N)
Electrode updatings
I(Cal 1)
Extrapolated
baseline
I(Cal 1,upd.2)
x x xx x x x x I(Cal 1,upd.1
x x x x x
I0(final)
t
N measurements of I0 Start of End of
on rinse solution Calibration Calibration
The current at the metabolite electrodes with Cal 1 in the measuring chamber,
I(Cal 1), is measured 30 times at regular intervals. The current at the 15th updating
B B
is used to determine sensitivity of the glucose electrode, and the current at the 30th
updating is used to determine sensitivity of the Lactate electrode.
The current due to the glucose or lactate presence in the sample is then calculated
as the difference between the current at the final updating (the 15th for the glucose
and the30th for the Lactate electrode) and the zero current at that time point:
2-16
ABL800 FLEX reference manual 2. Amperometric measuring principles
Sensitivity where:
(continued)
cX(Cal 1) = actual concentration of glucose/lactate in the Cal 1 solution
I0(final)
B B = extrapolated final zero current value of the metabolite
electrode at the time of the last updating
I(Cal 1)
T T =
T T T electrode current due to presence of glucose/lactateT
Drift The drift in the sensitivity of the metabolite electrodes is calculated from the
following equations:
The default drift tolerances set by Radiometer for the metabolite electrodes are:
0.5 mM for the Glucose electrode
0.2 mM for the Lactate electrode.
2-17
2. Amperometric measuring principles ABL800 FLEX reference manual
Corrections The measured metabolite concentration is corrected for systematic deviations from
the reference method by the following equations:
Equation A:
T
and
Equation B:
T T
where:
When an additional correction is needed, equation A is first used together with the
constants for the macromode. Then the obtained results are put back into equation
B as cX(sample) and then treated again, using the constants for the specific mode.
Note that subscript "macromode" in the equations above is used for the sake of
convenience and stands for S250, "FLEXMODE (no message)".
2-18
ABL800 FLEX reference manual 2. Amperometric measuring principles
2-19
2. Amperometric measuring principles ABL800 FLEX reference manual
(continued)
ABL8xx Mode A0
B B A1
B B Equation
FLEX
37/27/17 S250 0.97 -0.04 A
C125 0.97 -0.04 A
C35 1.202 -0.01 A, B
*FM (message 903) 0.99 0.07 A, B
*FM (message 902) 0.99 0.07 A, B
*FM (message 901) 0.99 0.07 A, B
*FM (message 900) 0.99 0.07 A, B
*FM (message 899) 0.99 0.07 A, B
*FM (message 898) 0.99 0.07 A, B
35/25/15 S195 0.97 -0.04 A
S95 1.03 0.03 A, B
C95 1.03 0.18 A, B
C35 1.13 0.05 A, B
*FM (no message) 0.97 -0.04 A
*FM (message 897) 1.03 0.18 A, B
*FM (message 895) 1.03 0.18 A, B
*FM (message 894) 1.03 0.18 A, B
*FM (message 873) 1.03 0.18 A, B
05 S165 0.97 -0.04 A
S95 1.03 0.03 A, B
C95 1.03 0.18 A, B
C35 1.13 0.05 A, B
*FM (no message) 0.97 -0.04 A
*FM (message 897) 1.03 0.18 A, B
*FM (message 895) 1.03 0.18 A, B
*FM (message 894) 1.03 0.18 A, B
*FM (message 873) 1.03 0.18 A, B
00 BASIC S195 0.97 -0.04 A
S95 1.03 0.03 A, B
C95 1.03 0.18 A, B
C35 1.13 0.05 A, B
*FM = FLEXMODE
2-20
ABL800 FLEX reference manual 2. Amperometric measuring principles
Stability criteria The following stability criteria must be met to obtain a stable electrode response
during calibration:
I(Cal 1,upd.30) I(Cal 1, upd.21) 9 Islope 0 B B
9.5
= 50
I(Cal 1, upd.1) I(Cal 1, upd.11)
log
I(Cal 1, upd.11) I(Cal 1, upd.21)
All of the three criteria must be fulfilled for a calibration using Cal 1 solution
where:
The following stability criterion must be met to obtain a stable electrode response
during measurement:
where:
Sd,zero
B B = spreading of the zero point current updatings around the
regression line
Sd,max
B B = if Sens > 400 pA/mM, then Sd,max = 0.025 Sens, B B B
2-21
2. Amperometric measuring principles ABL800 FLEX reference manual
otherwise
where:
If all the criteria below are fulfilled, then the result of the measurement will be
marked with an interference error.
I(sample, upd.30) - I(sample, upd.23)
1
I(sample, upd.16 - I(sample, upd.9)
I(sample,upd.16) > I(sample,upd.12)
I(sample,upd.12) > I(sample,upd.9)
cX(sample,corr)> 1.5 mmol/L
where:
I(sample,upd.9)
cX(sample,corr) = corrected concentration of glucose or lactate in
the sample
2-22
ABL800 FLEX reference manual 2. Amperometric measuring principles
Crea electrodes
Introduction Blood contains both creatinine and creatine. In order to measure creatinine, a two-
electrode system is used where one electrode (E8089) measures both substances,
and the other electrode (E8088) measures creatine only.
The measurement of creatinine is done by subtracting the signals from the two
electrodes and by compensating for any interferences in the blood sample. The
compensation requires that the electrode jackets have equal properties. To ensure
this, the electrode jackets are packed in pairs in the membrane boxes and the
electrodes may only be remembraned, using a pair of electrode jackets from the
same membrane box.
Description Both electrodes: Crea A, E8088 (brown with text in ivory), and Crea B, E8089
(ivory with text in brown), have a similar construction: each consists of a silver
cathode and a platinum anode. The electrode is protected by an electrode jacket
filled with electrolyte solution and a multilayer membrane mounted at the tip.
Electrode contact
Electrode jacket
Electrolyte
AgCl reference band
Multilayer membrane
2-23
2. Amperometric measuring principles ABL800 FLEX reference manual
Description Creatinine and creatine molecules are transported across the outer layer of the
(continued) multilayer membranes.
The enzymes creatininase (Crea B, E8089 electrode), creatinase and sarcosine
oxidase (Crea A, E8088 electrode) immobilized between the inner and outer
membrane layers change creatinine/creatine as follows:
The Crea B electrode (E8089) contains all three enzymes and detects both
creatinine and creatine (solid line). The Crea A electrode (E8088) contains only the
last two enzymes in the cascade and detects only creatine (dotted line).
O2 for these reactions is supplied through the outer membrane layer and also by the
B B
The H2O2 produced by the enzyme reaction is transported across the inner
B B B B
H2O2 2H+ + O2 + 2e
B B B B P P B B P P
In order to maintain a charge balance between the anode and the cathode, two Ag+ P P
2-24
ABL800 FLEX reference manual 2. Amperometric measuring principles
Calibration S1827 Calibration Solution 1 contains creatinine and is used for calibration of the
material Crea B electrode.
S1837 Calibration Solution 2 contains creatine and is used for calibration of the
Crea A and Crea B electrodes.
The precise start concentrations are contained in the barcodes of the S1827 and
S1837 Calibration Solutions that are scanned before the calibrating solutions are
installed on the analyzer.
Zero current The zero current (I0) is a small background current measured without presence of
B B
creatinine and creatine (i.e. Rinse Solution). Immediately before the electrode
calibration or sample measurement, the measuring chamber is flushed with Rinse
solution. The zero current is therefore obtained from continuous updatings during
this period. The baseline is then extrapolated (Slope 0) throughout the
measurement period for the calibration of the signal, originating from creatinine
and/or creatine in the calibration solution or sample.
Zero current Measurement
Slope 1
Slope 0
Slope 2
Electrode updatings
Zero current for data point n, I0(n), is then determined, using the following
B B
equation:
I0(n) = I0(47;57)median + Slope 0 (38 - n)
B B B B B B
where
I0 (47;57)median = median of the zero current between updatings 47 to 57
B B B B
The zero current of the creatinine electrodes should be less than 10.000 pA.
Continued on next page
2-25
2. Amperometric measuring principles ABL800 FLEX reference manual
Sensitivity During calibration the sensitivities of Crea A and Crea B electrodes are calculated.
For creatinine and creatine the following spontaneous reaction occurs in aqueous
solution:
creatinine + H2O creatine. B B
cCreatine(Cal1)
IB(Cal2) I0,B(Cal2) = SensB,Creatinine cCreatinine(Cal2) + SensB,Creatine
B B B B B B B B
cCreatine(Cal2)
where
IB(Cal1)
B B = the Crea B electrode signal obtained on
Calibration Solution 1
I0,B(Cal1)
B B = zero current of Crea B for measurement on
Calibration solution 1
IB(Cal2)
B B the Crea B electrode signal obtained on
Calibration Solution 2
I0,B(Cal2)
B B = zero current of Crea B for measurement on
Calibration solution 2
cCreatine (Cal1) = actual concentration of creatine (mol/L) in
Calibration Solution 1
cCreatinine (Cal1) = actual concentration of creatinine (mol/L) in
Calibration Solution 1
cCreatine(Cal2) = actual concentration of creatine (mol/L) in
Calibration Solution 2
cCreatinine(Cal2) = actual concentration of creatinine (mol/L) in
Calibration Solution 2
SensB,Creatinine B B = sensitivity of the Crea B electrode to creatinine
(pA(mM))
SensB,Creatine B B = sensitivity of the Crea B electrode to creatine
(pA(mM))
2-26
ABL800 FLEX reference manual 2. Amperometric measuring principles
where
IA(Cal2)
B B = the Crea A electrode signal obtained on
Calibration Solution 2
I0,A(Cal2)
B B = zero current of the Crea A for measurement on
Calibration solution 2
cCreatine (Cal2) = actual concentration of creatine (mol/L) in
Calibration Solution 2
SensA,Creatine B B = sensitivity of the Crea A electrode to creatine
(pA(mM))
Sensitivity of the electrodes is determined from their signals corrected for their
zero currents as follows:
(1):
[I (Cal1) I 0, B (Cal1)] cCreatine(Cal2) [I B (Cal2) I 0, B (Cal2)] cCreatine(Cal1)
Sens B, Creatinine =
B
(2):
[I (Cal2) I 0, B (Cal2)] cCreatinine(Cal1) [I B (Cal1) - I 0, B (Cal1)] cCreatinine(Cal2)
Sens B, Creatine =
B
(3):
I A (Cal2) I 0, A (Cal2)
Sens A, Creatine =
cCreatine(Cal 2)
cannot be determined directly from equation (1). The following equation, which
uses the sensitivities determined during the previous 2-point calibration (Cal2,
prev), is then used:
(4):
[I (Cal1) I 0, B (Cal1)]
Sens B, Creatinine =
B
2-27
2. Amperometric measuring principles ABL800 FLEX reference manual
Additional S1827 Calibration Solution 1 does not contain creatine. So if the Crea A electrode
checks during measures creatine during calibration on the Calibration Solution 1, the reason may
calibration be that:
electrodes were placed in the wrong chambers in the Met II module
calibration solutions were interchanged
calibration solutions were not stored as instructed, and some creatinine in the
Calibration Solution 1 has been converted to creatine
During each calibration, the performance of the Crea A and Crea B electrodes are
tested. If performance of either of the electrodes is not satisfactory it will be
indicated.
Drift The drift in the sensitivity of the Crea A and Crea B electrodes are calculated from
the following equations:
(5):
[I B
(Cal1, t) I 0, B (Cal1, t)] Sens B, Creatine (t 1) cCreatine(Cal1, t)
Drift B, Creatine =
Sens B, Creatinine (t 1)
cCreatinine(Cal1, t)
The nominal creatine concentration in the Calibration Solution 1 is used in
equation (5).
Drift in the creatine sensitivity of the Crea B electrode is determined only during
the 2-point calibration:
(6):
[I B
(Cal2, t) I 0, B (Cal2, t)] Sens B, Creatinine (t 1) cCreatinine(Cal2, t)
Drift B, Creatine =
Sens B, Creatine (t 1)
cCreatine(Cal2, t)
The nominal creatinine concentration in the Calibration Solution 2 is used in
equation (6).
Continued on next page
2-28
ABL800 FLEX reference manual 2. Amperometric measuring principles
Drift (continued) Drift in the creatine sensitivity of the Crea A electrode is determined only during
the 2-point calibration:
(7):
[I A
(Cal2, t) I 0, A (Cal2, t)] Sens A,Creatinine (t 1) cCreatinine(Cal2, t)
Drift A,Creatine =
Sens A,Creatine (t 1)
cCreatine(Cal2, t)
The default drift tolerances set by Radiometer are:
Electrode Drift tolerances
Crea B 15 M creatinine in Calibration Solution 1
15 M creatine in Calibration Solution 2
Crea A 15 M creatine in Calibration Solution 2
Measurements The concentration of creatine in the sample is determined from the electrode
and corrections response on the Crea A electrode as follows:
I A (sample) I 0, A
(8): cCreatine (sample) =
Sens A, Creatine
uncorr
Since the carry-over from the Rinse Solution for creatine is the same for the Crea
A and Crea B electrodes, the uncorrected creatine concentration from equation 8 is
then used to obtain the creatinine concentration in the sample:
(9): cCreatinineuncorr (sample) = (IB (sample) I0, B ) Sens B,Creatine cCreatineuncorr (sample)
Sens B,Creatinine
2-29
2. Amperometric measuring principles ABL800 FLEX reference manual
Measurements Then the measured creatinine concentration is corrected for carry-over from the
and corrections Rinse Solution as follows:
(continued)
Equation A:
cCrea(sample,corr) macromode = A0,macromode cCreatinineuncorr(sample) + A1,macromode
B B B B B B B B
Equation B:
cCrea(sample,corr)micromode = A0,micromode cCrea(sample)macromode + A1,micromode
B B B B B B B B
where:
cCrea(sample,corr) = corrected measured creatinine concentration from a sample
cCreatinineuncorr(sample) = uncorrected measured creatinine concentration from a
B B
sample
A0 = instrument-dependent correction factor
B B
A1 = instrument-dependent cut-off
B B
*FM = FLEXMODE
Whole blood The ABL8x7 FLEX analyzers are designed to measure cCrea on whole blood. If
correction plasma, serum or NIST SRM is to be measured on the ABL8x7 FLEX analyzers,
cCrea must be corrected as follows:
where
cCrea(ABL8x7,whole blood) is the result obtained on the analyzer.
2-30
ABL800 FLEX reference manual 2. Amperometric measuring principles
References
2-31
2. Amperometric measuring principles ABL800 FLEX reference manual
2-32
3. Optical measuring principles
Overview
Introduction This chapter describes the optical system, its construction and the measuring
method used.
Optical system
Measured The optical system of the ABL800 FLEX analyzer is designed to measure the
parameters following parameters:
Parameter Description
ctHb
T T Concentration of total hemoglobin
sO2 B B Oxygen saturation
FO2Hb B B Fraction of oxyhemoglobin
FCOHb Fraction of carboxyhemoglobin
FHHb Fraction of deoxyhemoglobin
FMetHb Fraction of methemoglobin
FHbF Fraction of fetal hemoglobin
ctBil
T T Concentration of total bilirubin (the sum of unconjugated
and conjugated bilirubin) in plasma
Slit
Optical fiber
Sample out
Hemolyzer Cuvette
Lamp unit
Infrared filter
Lens
Sample in
3-2
ABL800 FLEX reference manual 3. Optical measuring principles
Construction The method used in the analyzer's optical system is visible absorption
(continued)
T spectroscopy.
Step Description
1
T T The blood sample is transported to the cuvette positioned in the
hemolyzer unit. The temperature of the cuvette is regulated to 37 oC.
P P
2
T T
1 L of the sample is ultrasonically hemolyzed in the cuvette at a
frequency of about 30 kHz in order to rupture the walls of the red
blood cells so that their content is mixed with the blood plasma,
giving an optically clear solution. There is no bilirubin in the red
blood cells, so after hemolyzation the red blood cell intracellular fluid
dilutes the plasma bilirubin. The calculation discussed in
Measurement and Corrections corrects for this dilution.
T T
3-3
3. Optical measuring principles ABL800 FLEX reference manual
Lambert-Beers Absorption spectroscopy is based on Lambert-Beer's law which states that the
law measured absorbance for a single compound is directly proportional to the
concentration of the compound and the length of the light path through the sample
[1]:
Ay = y cy l
where:
Ay = absorbance of compound y at wavelength
Absorbance The absorbance (A) of a compound is defined as the logarithm of the ratio of the
light intensity before and after transmission through the compound.
In practice it is the logarithm of the ratio of the light intensity transmitted through
water to the light intensity transmitted through the compound.
I0
A = log
I
where:
I0 = intensity of light transmitted through water (I0 is measured as the T B TB
Total For samples containing more than one optically active compound, the total
absorbance absorbance (Atotal) is the sum of the individual compounds absorbance, since
B B
Atotal
1
= Ay + Ay + Ay + Ay + Ay + Ay 1
1
1
1
2
1
3 4
1 1
5 6
(
= l y c y + y c y + y c y + y c y + y c y + y c y
1
1 1
1
2 2 3
1
3
1
4 4
1
5 5
1
6 6
)
If there are Y compounds and measurements are taken at n wavelengths, a general T T
Y
Atotal = y cy l
n n
y =1
where:
n = the individual wavelengths.
B B
3-4
ABL800 FLEX reference manual 3. Optical measuring principles
n
Continuous Atotal can be depicted graphically as a function of wavelength, and if the
spectrum
differences between the wavelengths are small enough, a continuous spectrum is
produced.
EXAMPLES:
T
The figure below shows three spectra; pure O2Hb, pure HHb in a low B B
Absorption
480 500 520 540 560 580 600 620 640 660 680
Wavelength/nm
O2Hb (9.2 mmol/L)
HHb (0.8 mmol/L)
92 % oxygenated hemoglobin (i.e., 92 % O2Hb + 8 % HHb)
0.1
0.08
Absorba nce
0.06
0.04
0.02
0
470 520 570 620 670
nm
3-5
3. Optical measuring principles ABL800 FLEX reference manual
Determining In the spectrum taken of a sample, the absorption recorded at each wavelength
concentrations contains contributions from each of the compounds in the sample. The task then is
to determine the magnitude of that contribution and thereby the concentration of
each compound in the sample.
The concentrations are determined using the following equation:
128
cy = K y Atotal
n n
n =1
where:
K y
n
= a constant specific to compound y at wavelength n. B B
Matrix of The constants ( K y n ) are determined using Multivariate Data Analysis [2] where
constants
the spectra of the calibration compounds were considered together with the
reference values of the calibration compounds. The essential interfering substances
were also taken into account.
3-6
ABL800 FLEX reference manual 3. Optical measuring principles
HbF versus Fetal hemoglobin (HbF) does not have the same spectrum as adult hemoglobin
HbA (HbA) due to a slight variation in molecular structure. The presence of HbF in a
sample will interfere with the result if it is not corrected for.
It is thus important when measuring hemoglobin levels in premature neonates and
neonates aged 0 to 3 months, as well as adults suffering from thalassemia, to take into
account this difference [3].
The ABL800 FLEX analyzers automatically correct for HbF.
NOTE: Hb types other than HbA and HbF interfere with haemoglobin
T T
measurements and are not compensated for in the ABL800 FLEX analyzers.
The diagram below shows the transition from fetal hemoglobin to adult
hemoglobin [4].
Deviation of If the difference between the two types of hemoglobin is not accounted for in
results measurements on samples containing HbF, e.g. from premature neonates and
neonates aged 0 to 3 months, then a deviation in the measurement will arise.
The deviation is most important for measurements of oxygen saturation (sO2) and B B
Detecting HbF The presence of HbF in a sample is detected from the difference spectrum between
fetal and adult oxyhemoglobin. From the size of the difference spectrum the
concentration of fetal oxyhemoglobin, cO2HbF, can be measured.
T T B B
Correcting for The amount of cO2HbF exceeding a certain level indicates HbF interference. The
T T B B
HbF analyzer automatically corrects for this interference by subtracting the difference
spectrum of fetal oxyhemoglobin from the measured spectrum. It then makes
further calculations, using cO2HbF to measure FHbF.
T T B B T T
3-7
3. Optical measuring principles ABL800 FLEX reference manual
Most likely Fetal hemoglobin and non-hemoglobin substances present in blood that absorb
interfering light within the same wavelength range used to measure the oximetry parameters
substances and bilirubin, will interfere with the true spectra of the blood samples.
The optical system in the ABL800 FLEX analyzers compensates for the most
likely interfering substances by repressing their spectra.
The interference from the following substances the analyzer compensates for when
measuring the oximetry parameters:
Intralipids (turbidity)
Sulfhemoglobin, SHb
Repressing Repressing the spectra of the likely interfering substances is done in two ways
spectra depending on the substance:
Either the substance is taken account of in the calculation of the matrix of
T T
constants, K (see the section Measuring Principle in this chapter). This applies
T T
The same action is taken if one of the following conditions exists and FHbderiv is B B
3-8
ABL800 FLEX reference manual 3. Optical measuring principles
cO 2 Hb
sO2 =
B B
ceHb
ceHb = cHHb + cO2Hb (effective hemoglobin)
T T T T T T B B
cO 2 Hb
FO2Hb =
B B
ctHb
cCOHb
FCOHb =
ctHb
cHHb
FHHb =
ctHb
cMetHb
FMetHb =
ctHb
FHbF cHbF
=
ctHb
where:
cO2Hb B B = concentration of oxyhemoglobin in the sample
cCOHb = concentration of carboxyhemoglobin in the sample
cHHb = concentration of deoxyhemoglobin in the sample
cMetHb = concentration of methemoglobin in the sample
cHbF
T T = concentration of fetal hemoglobin in the sample
3-9
3. Optical measuring principles ABL800 FLEX reference manual
Bilirubin 0.0301
Hct(calc) = ctHb
T
(continued) T
g / dL
For further details on Hct(calc) please refer to Interference Tests and the
T T
FHHb
ctHb < 1 mmol/L
ctBil
T T ctHb > 15.5 mmol/L
than 0.2.
"HbF correction" has No lower limit value for cO2HbF is required, i.e. T T B B
been activated even adult blood samples will be corrected for HbF.
It may be of value when analyzing blood samples
from newborns who received adult blood transfusion.
In these cases FHbF can be lower than 20 % and
significant deviations of oximetry parameters and
bilirubin can occur.
HbF suppression has The FHbF value is displayed by the ABL835/30
been activated FLEX analyzers.
Message HbF detected is displayed on the other
analyzer versions with the oximetry module
installed.
sO2 < 50 % or B B Message FHbF measurement is not possible is
displayed by the ABL835/30 FLEX analyzers if a
ctHb < 5 mmol/L
HbF suppression has been activated.
3-10
ABL800 FLEX reference manual 3. Optical measuring principles
ctHb(sample)
ctHb(sample, corr) =
Fcuv Fdil
where:
ctHb(sample,corr) = corrected ctHb
FcuvB B = analyzer-dependent constant determined at tHb
calibrations and automatically stored by the analyzer
FdilB B = analyzer-dependent constant determined during tests
against the reference method, which corrects for Hb
dilution in the different aspiration modes.
ABL8xx
T T Mode T Fdil
T B TB T EquationT
FLEX T
3-11
3. Optical measuring principles ABL800 FLEX reference manual
Corrections for
ctHb (continued)
T T T
ABL8xx Mode Fdil Equation
FLEX
35/25/15 S195 1.0000 A
S95 0.9630 A
S85 1.0050 A
C95 0.9630 A
C55 0.9220 A
C35OXI 0.9570 A
*FM (no message) 1.0110 A
*FM (message 897) 0.9630 A
*FM (message 895) 0.9630 A
*FM (message 894) 0.9630 A
*FM (message 873) 0.9630 A
*FM (message 872) 0.9490 A
*FM (message 871) 0.9440 A
*FM (message 870) 0.9230 A
*FM (message 869) 0.9230 A
30/20/10 S85 1.0050 A
10 BG only C55 0.9220 A
FLEX C35 OXI 0.9570 A
*FM (no message) 0.9750 A
*FM (message 872) 0.9490 A
*FM (message 871) 0.9440 A
*FM (message 870) 0.9230 A
*FM (message 869) 0.9230 A
00 BASIC S195 1.0000 A
S95 0.9630 A
S85 1.0050 A
C95 0.9630 A
C35OXI 0.9570 A
*FM = FLEXMODE
3-12
ABL800 FLEX reference manual 3. Optical measuring principles
Corrections for The uncorrected total bilirubin concentration, ctBil(sample), measured on capillary
ctBil
T T
or syringe samples is corrected as follows:
Equation A:
T
ctBil(sample)
ctBil(sample, corr) =
Fcuv Fdil
where:
ctBil(sample,corr) = corrected ctBil
Fcuv
B B = analyzer-dependent constant determined at tHb
calibrations and automatically stored by the analyzer
Fdil B B = analyzer-dependent constant determined during tests
against the reference method, which corrects for ctBil T T
ABL8xx
T T Mode
T T T Fdil
B TB Equation
T T
37 S250 1.0050 A
C125 0.9900 A
*FM (message 903) 0.9432 A
*FM (message 902) 0.9432 A
*FM (message 901) 0.9432 A
*FM (message 900) 0.9432 A
*FM (message 899) 0.9432 A
*FM (message 898) 0.9432 A
*FM = FLEXMODE
3-13
3. Optical measuring principles ABL800 FLEX reference manual
Corrections for
ctBil (continued)
T T T
ABL8xx Mode Fdil Equation
35 S195 1.0050 A
S95 0.9320 A
S85 1.0000 A
C95 0.9320 A
C55 0.8640 A
C35 OXI 0.9160 A
*FM (no message) 0.9900 A
*FM (message 897) N/A
*FM (message 895) N/A
*FM (message 894) N/A
*FM (message 873) N/A
*FM (message 872) N/A
*FM (message 871) N/A
*FM (message 870) N/A
*FM (message 869) N/A
30 S85 1.0000 A
C55 0.8640 A
C35 OXI 0.9160 A
*FM (no message) 0.9570 A
*FM (message 872) N/A
*FM (message 871) N/A
*FM (message 870) N/A
*FM (message 869) N/A
*FM = FLEXMODE
3-14
ABL800 FLEX reference manual 3. Optical measuring principles
References
List of The list of the references for chapter 3, The Optical Measuring Principles:
T T
references
1. Ewing GW. Instrumental methods of chemical analysis. 5th ed. McGraw-Hill,
1985.
2. Martens H. Multivariate calibration: quantitative interpretation of non-selective
chemical data. Dr. Techn. Thesis, NTH Univ. of Trondheim, 1986.
3. Krzeminski A. Why correct for fetal hemoglobin in blood oximetry
measurements? Radiometer Publication Info. No. 1992-3. Copenhagen:
Radiometer Medical A/S, 1992.
4. Huehns ER, Beaven GH. Developmental changes in human hemoglobins. Clin
Dev Med 1971; 37: 175-203.
3-15
3. Optical measuring principles ABL800 FLEX reference manual
3-16
4. User-defined corrections
Overview
Introduction This chapter describes the basis of the user-defined corrections available for all the
measured parameters.
4-1
4. User-defined corrections ABL800 FLEX reference manual
General information
Purpose of use User-defined corrections are most commonly implemented in situations where the
values measured for a particular parameter by two or more analyzers, deviate
consistently from each other.
NOTE:
T T Since the performance of all analyzers is tested as described in chapter
5, Performance Characteristics, and each instrument is assumed to
operate accurately and optimally, the unnecessary correction of
parameter values by the user can lead to inaccurate measurements
being reported.
User-defined User-defined corrections are based on a linear correlation between the measured
corrections values (without user-defined corrections) and the displayed values (with user-
defined corrections).
The correction factors for each measured parameter are the slope and the offset of
the correction line. With user-defined corrections it is possible to change the values
of either one or both of these correction factors, depending on the parameter type.
Slope = 1
Offset
Measured
(uncorrected)
0.0 parameter value
4-2
ABL800 FLEX reference manual 4. User-defined corrections
Entering The slope/offset for each parameter are configured in the General Setup >
user-defined Parameters Setup. User-corrected values are marked with a * after the result.
corrections
NOTE: The user-defined corrections will be applied to measurements on QC
solution unless the "Apply parameter corrections to QC" option was
deactivated in Miscellaneous Setup.
For detailed instructions on how to enter user-defined corrections, refer to the
section Parameter Setup in chapter 3 of the Operators Manual.
T T T T T T
4-3
4. User-defined corrections ABL800 FLEX reference manual
Allowed The following corrections can be user-defined for the oximetry parameters and
corrections bilirubin:
ctHb
T T T Yes No
sO2
T T B TB Yes Yes
FCOHb
T T T No Yes
FMetHb
T T T No Yes
FO2Hb
T T B B T No No
FHHb
T T T No No
FHbF
T T Yes Yes
ctBil
T T T Yes Yes
Item Description
Units g/dL; g/L; mmol/L
Sample Set ctHb of a SAT100 sample to 15 g/dL (9.3 mmol/L) and
T T
pH 7.4
ctHb, maximum Uncorrected or corrected: 15 g/dL or 9.3 mmol/L
point
Slope 0.950-1.050
sO2
B B The following recommendations apply to sO2 : B B
Item Description
Units Fraction
Sample Set ctHb of gas equilibrated SAT0 and SAT100 samples to
T T
4-4
ABL800 FLEX reference manual 4. User-defined corrections
7.4.
Offset 0.050
7.4.
Offset 0.050
4-5
4. User-defined corrections ABL800 FLEX reference manual
ctBil
T T The following recommendations apply to ctBil:
Item Description
Units mol/L
Sample Radiometer recommends that human plasma or serum is used
with pH 7.4 (the analyzer reading). Zero point sample could
be adult sample (ctBil 0 mol/L) and maximum point could
be an unconjugated bilirubin sample with ctBil 300-400 T T
mol/L.
Averaging repeated measurements on samples from different
donors gives an optimized accuracy of the correction.
Averaging repeated measurements on samples from the same
donor also improves the accuracy.
Commercial bilirubin standards can interfere with bilirubin
measurement because they may have an absorbance spectrum
different from that of human plasma.
Slope 0.5-1.5
Offset 100
FO2Hb and
B B
The units for FO2Hb and FHHb are [Fraction]. T T B B T T
FHHb
After the user-defined corrections of the parameters sO2, FCOHb and FMetHb T T B B T T T T
have been carried out, FO2Hb and FHHb are automatically calculated using the B B T T
formulae stated below, since the sum of the fractions FCOHb, FMetHb, FO2Hb T T T T B B
FO2Hb:
T B B T
FHHb:
T T T
4-6
ABL800 FLEX reference manual 4. User-defined corrections
Preparatory Prior to entering corrections for the electrolyte and metabolite parameters, the user
actions must obtain the reference values for the chosen parameters using the method
accepted in his/her laboratory.
Conditions in chapter 5.
T T T
Correcting the The following corrections to the slope are possible within the stated limits:
slope
Parameter
T T T Slope (mmol/L) T
cK+
T T P P 0.750-1.250
+
cNa
T T P P 0.850-1.150
2+
cCa
T T P P 0.800-1.200
cCl
T T P P 0.850-1.150
cGlu
T T 0.750-1.250
cLac
T T 0.750-1.250
cCrea
T T 0.75-1.250
Correcting the The following corrections to the offset are possible within the stated limits:
offset
Parameter:
T T T cK+
T P P T cNa+T P P cCa2+
T T P P
T cCl
T P P cGlu
T T cLac
T T cCrea
T T
Offset
T 0.3 5 0.05 5 0.5 0.5 100 mol/L
(mmol/L): T
4-7
4. User-defined corrections ABL800 FLEX reference manual
Resetting The Radiometer default values for the electrolyte and metabolite parameters must
corrections to be reset manually by the user to 1.000 for each parameter on the Parameters
T
4-8
5. Performance characteristics
Overview
+
Performance test results cK ................................................................... 5-18
P P X X
+
Performance test results cNa .................................................................. 5-20
P P X X
2+
Performance test results cCa ................................................................ 5-28
P P X X
5-1
5. Performance characteristics ABL800 FLEX reference manual
Definition of terms
ABL735 analyzer.
Repeatability
Reproducibility
Total variation range
Imprecision
Bias The bias of a quantity is defined as the mean difference between the measured
value on a group of test instruments and the estimated true value (as assayed by the
reference method). BiasRef is determined as follows:
B B
BiasABL is a relative bias between the ABL835 FLEX analyzer in FLEXMODE and
B B
Bias given in the tables in this chapter have been obtained experimentally.
Repeatability Samples, assumed to be identical, repeatedly measured on one analyzer will not
necessarily yield identical results. The degree of variation in the results is a
measure of the repeatability of the analyzer.
The repeatability is obtained from repeated measurements within a short interval of
time using:
The same instrument and location
The same measurement procedure
Identical portions of the same sample
One operator per instrument
The repeatability for each level is pooled for all test instruments and test days.
5-2
ABL800 FLEX reference manual 5. Performance characteristics
Reproducibility Reproducibility is obtained from repeated measurements over several days using:
Random instrument
Random sample
Random operators
Reproducibility for each level is pooled for all test instruments and test days.
Total analytical TEA, total analytical error is a quality specification that sets a limit for both the
TB TB
are using for total error allowable works at 95% probability to allow for 5% error.
Parameter Description
S0 B B Repeatability
T
SD B B Day-to-day variation
T
5-3
5. Performance characteristics ABL800 FLEX reference manual
S0, SD and SABL given in the tables are Radiometer requirements. Experimental data
B B B B B B
Confidence Confidence interval provides a range of values estimated from a study group that is
intervalsT highly likely to include the true, but unknown, value ("confidence interval" applies
to the results of a statistical analysis). A 95 % confidence interval means that there
is only a 5 % chance that the true value is not included in the interval.
Prediction The 95 % prediction interval is much wider than the 95 % confidence interval
interval about, for example, the mean regression line response. For any given value of the
independent variable, this interval represents the 95 % probability for the values of
the dependent variable.
5-4
ABL800 FLEX reference manual 5. Performance characteristics
Overview
+
Performance test results cNa ....................................................................... 5-20
P P X X
Performance test results cCl ......................................................................... 5-22
P P X X
5-5
5. Performance characteristics ABL800 FLEX reference manual
Test conditions
ABL8x0/8x5 Test conditions to determine biasABL, repeatability and total variation for pH,
B B
pCO2, pO2, cCa2+, cCl, cK+, cNa+, cGlu, cLac, ctHb were as follows:
B B B B P P P P P P P P
Item Description
Reference analyzers Five ABL735 with AutoCheck module were used as a
reference. The C195 mode was used as a reference for
all measured parameters.
Primary reference As specified for each parameter further in this chapter.
methods
Analyzers and test Five ABL835, three ABL830 and three ABL805 were
modes tested over 11 days in the following modes:
Syringe: S195, S165, S95, S85
Capillary: FLEXMODE, C95, C85, C55, C35
OXI, C35 MET
Blood samples Heparinized blood samples from healthy, voluntary
donors.
Eleven blood pools were prepared to cover test ranges
for all measured parameters.
Blood measurements The measurements were performed by different
operators.
Calibration solution and All calibration solutions and gases used for the tests
gases are traceable to Primary Reference Standards.
Traceability certificates for the ABL800 FLEX
calibration solutions and gases are found at the end of
chapter 7: Solutions. T T
NOTES:
T
The solutions used in the performance tests are those recommended by
T
5-6
ABL800 FLEX reference manual 5. Performance characteristics
BiasABL chart
B B The legend of the BiasABL chart is given below:
B B
description
Chart Description
"x" axis The ABL735 mean values obtained as follows:
To determine the best possible ABL735 reference value for each
parameter of a specific sample, the measurements on five
ABL735 analyzers are plotted as a function of time. A regression
line is made to represent the best possible mean ABL735
measurement at a given time thus compensating the metabolism
of the sample during repeated measurements on it.
"y" axis Bias in %; bias for pH in pH units.
95 % statistical confidence range for bias in macromodes.
95 % statistical confidence range for bias in micromodes.
Nmacro
B B Number of measurements in macromodes.
Nmicro
B B Number of measurements in micromodes.
5-7
5. Performance characteristics ABL800 FLEX reference manual
Chart Description
"x" axis The ABL800 FLEX mean value.
"y" axis Repeatability in %; repeatability for pH in pH units.
Repeatability in macromodes.
Repeatability in micromodes.
Nmacro
B B Number of measurements in macromodes.
Nmicro
B B Number of measurements in micromodes.
Total variation Total variation chart is presented as a difference plot against the regression line at
chart 5 ABL735 analyzers. The individual measurements are plotted directly.
Chart Description
"x" axis The ABL735 mean values obtained as follows:
To determine the best possible ABL735 reference value for each
parameter of a specific sample, the measurements on five
ABL735 analyzers are plotted as a function of time. A regression
line is made to represent the best possible mean ABL735
measurement at a given time thus compensating the metabolism
of the sample during repeated measurements on it.
"y" axis Total variation in %; total variation for pH in pH units.
At least 95 % statistical confidence range for total variation in
macromodes.
At least 95 % statistical confidence range for total variation in
micromodes.
o Observations in macromode.
x Observation in micromode.
Nmacro
B B
Number of measurements in macromode see the next page.
Nmicro B B
Number of measurements in micromode see the next page.
5-8
ABL800 FLEX reference manual 5. Performance characteristics
Number of The number of measurements in macro- and micromodes, and the total number of
measurements measurements during the test is listed below:
Parameter Nmacro
B B Nmicro
B B Total
pH 3334 421 3755
pCO2 B B 2768 397 3165
pO2 B B 282 2912 3194
+
cKP P 422 1364 1786
+
cNa P P 423 1362 1785
2+
cCa P P 407 1148 1555
cCl P P 426 1360 1786
cGlu 423 1825 2248
cLac 412 1829 2241
ctHb 415 3032 3447
5-9
5. Performance characteristics ABL800 FLEX reference manual
Reference Capillary-type glass pH electrode with a saturated calomel reference electrode and
method a liquid junction saturated with KCl (BMS Mk2) [1,2].
The calibration standards are traceable to the Primary Reference Standards for pH.
BiasREF
B B The FLEXMODE on the ABL805/30/35 FLEX analyzers was tested:
pH Bias REF
B B N
7.0 0.002 90
7.4 0.002 90
7.7 0.002 90
N = number of measurements on several analyzers used for the test.
BiasABL blood
B B This bias is presented by the following chart:
samples
Bias (pH)
ABL735 (pH)
5-10
ABL800 FLEX reference manual 5. Performance characteristics
Repeatability (pH)
ABL800 FLEX
ABL735
5-11
5. Performance characteristics ABL800 FLEX reference manual
BiasREF
B B The FLEXMODE on the ABL805/30/35 FLEX analyzers was tested:
pCO2 (mmHg)
B B Bias REFB B N
15 0.11 60
40 0.38 60
60 0.29 60
80 0.20 60
150 0.21 60
BiasABL blood
B B This bias is presented by the following chart:
samples
Bias (%)
ABL735 (mmHg)
5-12
ABL800 FLEX reference manual 5. Performance characteristics
Repeatability (%)
ABL735 (mmHg)
5-13
5. Performance characteristics ABL800 FLEX reference manual
Bias and The bias and imprecision for expired air samples are as follows*:
imprecision
expired air
samples pCO2 (mmHg)
T B B T Bias T
ABL835/30/25/20/15/10/05 T
15 0.2
40 0.2
60 0.4
80 0.2
150 1.6
pCO2
T B B S0
T B TB T SD B TB T SABLB TB T SX
B TB
(mmHg) T
* The Expired air mode is unchanged in the ABL800 FLEX analyzers compared to
the ABL700 Series and, consequently, was not retested for the ABL800 FLEX
analyzers.
5-14
ABL800 FLEX reference manual 5. Performance characteristics
BiasREF
B B The FLEXMODE on the ABL805/30/35 FLEX analyzers was tested:
pO2 (mmHg)
B B Bias REF B B N
15 0.47 60
50 0.24 60
150 0.45 60
250 2.17 60
530 1.01 60
BiasABL blood
B B This bias is presented by the following chart:
samples
Bias (%)
ABL735 (mmHg)
5-15
5. Performance characteristics ABL800 FLEX reference manual
Repeatability (%)
ABL835 (mmHg)
ABL735 (mmHg)
5-16
ABL800 FLEX reference manual 5. Performance characteristics
Bias and The bias and imprecision for expired air samples are as follows:
imprecision
expired air
samples pO2 (mmHg)
T B B T Bias T
ABL835/30/25/20/15/10/05 T
15 0.8
40 0.4
130 0.4
230 0.9
570 4.2
Imprecision:
pO2 (mmHg)
T B B T S0
T B TB T SD B TB T SABLB TB T SX
B TB
Fifteen ABL700 Series and ABL800 FLEX analyzers are tested over three days for
all levels. Bias is determined against certified gases at sea level.
5-17
5. Performance characteristics ABL800 FLEX reference manual
BiasREF
B B The FLEXMODE on the ABL805/35 FLEX analyzers was tested using SRM
909b:
cK+ (mmol/L)
P P Bias REF B B N
3.424 0.03 20
6.278 0.23 20
BiasABL blood
B B This bias is presented by the following chart:
samples
Bias (%)
ABL735 (mmol/L)
5-18
ABL800 FLEX reference manual 5. Performance characteristics
Repeatability (%)
ABL735 (mmol/L)
5-19
5. Performance characteristics ABL800 FLEX reference manual
Reference NIST-certified Standard Reference Material SRM 909b (human serum) and
method Radiometer specified standard serum material (specified using flame photometry).
BiasREF
B B The FLEXMODE on the ABL805/35 FLEX analyzers was tested:
cNa+ (mmol/L)
P P Bias REF B B N
120.76* 0.25 20
138.5** 0.28 30
N = number of measurements on several analysers used for the test.
(*NIST-certified Standard Reference Material
** Serum (Radiometer-specified).
BiasABL blood
B B This bias is presented by the following chart:
samples
Bias (%)
ABL735 (mmol/L)
5-20
ABL800 FLEX reference manual 5. Performance characteristics
Repeatability (%)
ABL735 (mmol/L)
5-21
5. Performance characteristics ABL800 FLEX reference manual
BiasREF
B B The FLEXMODE on the ABL805/35 FLEX analyzers was tested using SRM
909b:
cCl (mmol/L)
P P Bias REF B B N
89.11 0.6 20
119.43 2.4 20
BiasABL blood
B B This bias is presented by the following chart:
samples
Bias (%)
ABL735 (mmol/L)
5-22
ABL800 FLEX reference manual 5. Performance characteristics
Repeatability (%)
ABL735 (mmol/L)
5-23
5. Performance characteristics ABL800 FLEX reference manual
Reference The calcium transfer standards were used. These are traceable to NIST SRM915
method and have an ionic strength of 160.0 mmol per kg of water and pH 7.40 at 37 C,
using 1 mmol/L (37 C) HEPES buffer.
The standards were produced as indicated in [4].
BiasREF
B B The FLEXMODE on the ABL805/35 FLEX analyzers was tested:
cCa2+ (mmol/L)
P P BiasREFB B N
0.4879 0.038 150
1.2700 0.025 150
2.5657 0.052 150
BiasABL blood
B B This bias is presented by the following chart:
samples
Bias (%)
ABL735 (mmol/L)
5-24
ABL800 FLEX reference manual 5. Performance characteristics
ABL735 (mmol/L)
5-25
5. Performance characteristics ABL800 FLEX reference manual
BiasREF
B B The FLEXMODE on the ABL805/35 FLEX analyzers was tested:
cGlu(mmol/L) BiasREF
B B N
0.08 0.03 30
2.09 0.06 30
5.08 0.12 30
14.73 0.02 30
BiasABL blood
B B This bias is presented by the following chart:
samples
Bias (%)
ABL735 (mmol/L)
5-26
ABL800 FLEX reference manual 5. Performance characteristics
Repeatability (%)
ABL735 (mmol/L)
5-27
5. Performance characteristics ABL800 FLEX reference manual
BiasREF
B B The FLEXMODE on the ABL805/35 FLEX analyzers was tested:
BiasABL blood
B B This bias is presented by the following chart:
samples
Bias (%)
ABL735 (mmol/L)
5-28
ABL800 FLEX reference manual 5. Performance characteristics
ABL735 (mmol/L)
5-29
5. Performance characteristics ABL800 FLEX reference manual
BiasREF
B B The FLEXMODE on the ABL830/35 FLEX analyzers was tested:
BiasABL
B B This bias is presented by the following chart:
Bias (%)
ABL735 (g/dL)
5-30
ABL800 FLEX reference manual 5. Performance characteristics
Repeatability (%)
ABL735 (g/dL)
5-31
5. Performance characteristics ABL800 FLEX reference manual
Explanation The optical system is unchanged in the ABL800 FLEX analyzers compared to the
ABL700 Series. Test of ctHb on the ABL800 FLEX analyzers has been conducted
T T
(results given on pages 5-31 to 5-32). The other oximetry parameters have not been
retested; the information and results below are from the ABL700 Series.
Reference The reference method established for the oximetry parameters uses modified
methods ABL520 analyzers as the reference instruments. The ABL520 analyzers have been
validated and their performance specifications determined according to primary
reference methods.
The modified ABL520 analyzers are used in accordance with IFCCs
recommendations for traceability of reference methods.
The reference methods used for the oximetry parameters on the ABL520 analyzers
are those presented below.
with dithionite.
FCOHb Gas chromatography. The standards are carbon
monoxide mixtures with atmospheric air, whose
purity is validated in accordance with NIST SRM
1678 (50 ppm CO in N2). B B
Test conditions
for oximetry Test Description
parameters Reference To verify that the correction constants have been
accurately determined, 10 analyzers with all
parameters available are tested in C195 mode against
the reference methods.
Each parameter is tested on 3-6 levels over at least
three days, with five repetitions each day.
(Five new analyzers with all parameters available
were tested against the reference methods for FHbF).
Bias for each parameter in the C195 measuring mode
against the reference method is determined.
5-32
ABL800 FLEX reference manual 5. Performance characteristics
Test conditions
for oximetry Test Description
parameters Verification 6-10 ABL700 Series analyzers are tested over at least
(continued)
T
two days for all levels. Bias for the given mode is
calculated as difference compared to the C195 mode.
Bias against the reference method is determined as
follows:
Bias = bias against C195 + C195 bias against
reference method.
The following parameters: sO2, FCOHb, FMetHb and
B B
5-33
5. Performance characteristics ABL800 FLEX reference manual
sO2
B B
Bias:
macromodes
sO2 (%)
T T B B T ABL835/25/15
T T ABL830/20/10
T T
ctHb (g/dL)
T T T T sO2 (%) T B B T T S195 T FM*
T T T S85 T
sO2
B B Bias:
micromodes
sO2
T B TB T ABL835/25/15 T T ABL830/20/10 T
ctHb T T sO2
T B B T S95 T T C95 T T S85 T C55
T T C35
T T FM*
T T T C55 T T C35 T
(g/dL) T (%) T
5-34
ABL800 FLEX reference manual 5. Performance characteristics
FO2Hb
B B Bias:
macromodes
FO2Hb B B ABL835/25 ABL830/20
ctHb (g/dL)
T T FO2Hb (%)
T T B B S195 FM* S85
15 0 0.00 0.04 0.02
7 100 0.07 N/A N/A
15 100 0.03 N/A 0.15
25 100 0.05 N/A N/A
* FM = FLEXMODE (no message)
Imprecision:
ctHb (g/dL)
T T FO2Hb B B S0
B B SDB B SABL
B B SX
B B
(%)
15 0 0.05 0.05 0.25 0.30
7 100 0.25 0.20 0.50 0.60
15 100 0.15 0.15 0.45 0.50
25 100 0.10 0.10 0.40 0.45
FO2Hb
B B Bias:
micromodes
FO2Hb (%)
B B ABL835/25
ctHb (g/dL)
T T FO2Hb (%)
T T B B S95 C95 S85 C55 C35
15 0 0.04 0.02 0.02 0.03 0.03
7 100 0.47 0.39 N/A 0.48 0.18
15 100 0.33 0.40 0.15 0.39 0.31
25 100 0.29 0.46 N/A 0.36 0.33
FO2Hb B B ABL830/20
ctHb (g/dL)
T T FO2Hb (%)
T T B B C85 C55 C35
15 0 N/A 0.03 0.03
7 100 N/A 0.48 0.18
15 100 0.16 0.39 0.31
25 100 N/A 0.36 0.33
5-35
5. Performance characteristics ABL800 FLEX reference manual
FO2Hb
T T B B Imprecision:
micromodes
ctHb (g/dL) FO2Hb (%) S0 SD SABL SX
(continued)
T T B B B B B B B B B B
T T
FCOHb Bias:
macromodes
FCOHb ABL835/25 ABL830/20
ctHb (g/dL)
T T sO2 (%)
B B FCOHb
T T S195 FM* S85
(%)
15 100 0 0.03 0.08 0.12
7 100 20 N/A 0.47 N/A
15 100 20 N/A 0.10 N/A
25 100 20 N/A 0.47 N/A
* FM = FLEXMODE (no message)
Imprecision:
ctHb (g/dL)
T T sO2 (%)
B B FCOHb (%) S0
B B SD B B SABL
B B SX
B B
Imprecision (ABL837/27):
ctHb (g/dL)
T T sO2 (%)
B B FCOHb (%) S0
B B SD B B SABL
B B SX
B B
5-36
ABL800 FLEX reference manual 5. Performance characteristics
FCOHb Bias:
micromodes
FCOHb ABL835/25
ctHb T T sO2
B B FCOHb
T T S95 C95 S85 C55 C35
(g/dL) (%) (%)
15 100 0 0.10 0.10 0.12 0.08 0.08
7 100 20 N/A N/A N/A N/A N/A
15 100 20 N/A N/A N/A N/A N/A
25 100 20 N/A N/A N/A N/A N/A
FCOHb ABL830/20
ctHb (g/dL)
T T sO2 (%) B B FCOHb (%)
T T FM* C55 C35
15 100 0 0.02 0.08 0.08
7 100 20 N/A N/A N/A
15 100 20 N/A N/A N/A
25 100 20 N/A N/A N/A
* FM = FLEXMODE (no message)
Imprecision:
ctHb (g/dL)
T T sO2 (%)
T T B B FCOHb (%) S0 B B SD
B B SABL
B B SXB B
FMetHb Bias:
macromodes
FMetHb ABL835/25 ABL830/20
ctHb (g/dL)
T T sO2 (%) B B FMetHb (%)
T T S195 FM* S85
15 100 0 0.01 0.03 0.06
15 100 20 N/A 0.10 N/A
* FM = FLEXMODE (no message)
5-37
5. Performance characteristics ABL800 FLEX reference manual
FMetHb
T T Imprecision:
macromodes
ctHb (g/dL) sO2 (%) FMetHb (%) S0 SD SABL SX
(continued)
T T B B T T B B B B B B B B
T T
FMetHb
T T Bias:
micromodes
FMetHb ABL835/25
TctHb T sO2 (%)
B B FMetHb
T T S95 C95 S85 C55 C35
(g/dL) (%)
15 100 0 0.13 0.14 0.06 0.16 0.14
7 100 20 N/A N/A N/A N/A N/A
15 100 20 N/A N/A N/A N/A N/A
25 100 20 N/A N/A N/A N/A N/A
FMetHb ABL830/20
ctHb (g/dL)
T T sO2 (%) B B FMetHb (%)
T T FM* C55 C35
15 100 0 0.13 0.16 0.14
7 100 20 N/A N/A N/A
15 100 20 N/A N/A N/A
25 100 20 N/A N/A N/A
* FM = FLEXMODE (no message)
Imprecision:
ctHb (g/dL)
T T sO2 (%)
T T B B FMetHb(%) S0
B B SD B B SABL
B B SXB B
5-38
ABL800 FLEX reference manual 5. Performance characteristics
FHHb Bias:
macromodes
FHHb ABL835/25 ABL830/20
FHHb (%)
T T ctHb (g/dL)
T T S195 FM* S85
0 15 0.01 0.08 0.05
* FM = FLEXMODE (no message)
Imprecision:
FHHb (%) ctHb (g/dL)
T T S0
B B SD B B SABL
B B SXB B
FHHb Bias:
micromodes
FHHb ABL835/25 ABL830/20
TctHb T FHHb S95 C95 S85 C55 C35 FM* C55 C35
(g/dL) (%)
15 0 0.09 N/A N/A 0.15 0.10 N/A N/A 0.10
* FM = FLEXMODE (no message)
Imprecision:
ctHb (g/dL)
T T FHHb (%) S0
B B SD B B SABL B B SX B B
0 10 100 4 4 5 8
0 15 100 2 3 7 8
0 20 100 2 2 10 11
5-39
5. Performance characteristics ABL800 FLEX reference manual
ctHb
T T FHbF
T T S95 C95 S85 C55 C35 FM* C55 C35
(g/dL) (%)
1 0 3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3
0
1 0 5.5 5.5 5.5 5.5 5.5 5.5 5.5 5.5
5
2 0 5.6 5.6 5.6 5.6 5.6 5.6 5.6 5.6
0
* FM = FLEXMODE (no message)
Imprecision (micromodes):
ctHb (g/dL)
T T FHbF (%)
T T sO2 (%)
B B S0
B B SD
B B SABLB B SX B B
10 0 100 4 4 5 8
15 2 3 5 7
20 2 2 10 11
NOTES: a, b.
Imprecision (macromodes):
FHbF (%) ctHb (g/dL)
T T sO2 (%)
T T B B S0
B B SD
B B SABL
B B SX
B B
80 10 100 4 5 5 9
80 15 100 3 3 6 8
80 20 100 2 3 6 7
NOTES: a, b.
5-40
ABL800 FLEX reference manual 5. Performance characteristics
TctHb
T FHbF S95 C95 S85 C55 C35 FM* C55 C35
(g/dL) (%)
10 80 5.9 5.9 5.9 5.9 5.9 5.9 5.9 5.9
15 80 3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3
20 80 2.6 2.6 2.6 2.6 2.6 2.6 2.6 2.6
* FM = FLEXMODE (no message)
Imprecision (micromodes):
FHbF (%) ctHb (g/dL)
T T sO2 (%)
B B S0B B SD
B B SABL
B B SX
B B
80 10 100 4 5 6 9
15 3 3 6 8
20 2 3 6 7
NOTES: a, b.
Contribution to The following corrections should be geometrically added to SInst and SX for the B B B B
NOTES:
5-41
5. Performance characteristics ABL800 FLEX reference manual
Explanation As the optical system is unchanged in the ABL800 FLEX analyzers compared to
the ABL700 Series, the specifications for bilirubin have not been re-established.
Field test results The ABL735/30 performance specifications for bilirubin were made as a field test
the purpose of which was to optimize the bilirubin algorithm for neonatal blood
samples.
For neonatal use: The bilirubin method has been evaluated on whole blood
and plasma. The allowed analytical error is 10 % to
satisfy average clinical requirements for bilirubin
measurement [1,2,3,4,5]. This requirement is fulfilled for
plasma. For whole blood the analytical error is slightly
higher. The clinicians and clinical chemists have evaluated
bilirubin measurement on whole blood, the conclusion
being that the ABL735/30 analyzers have satisfactory
performance and can substitute other bilirubin measuring
methods.
For adult use: Adult samples within reference range:
The uncertainty in the bilirubin measurement on whole
blood can, in some cases, exceed the level required to
measure normal bilirubin levels for children older than 3
months and adults (bilirubin reference range 4-22 mol/L).
In these cases it is recommended to measure bilirubin on
plasma or serum.
The patient samples represented typical variations in ctBil, ctHb, sO2, pH and
T T T T B B
MCHC values.
A Hitachi analyzer calibrated with NIST SRM 916a standards was used as a
reference. ctBil was measured in mol/L. Each field test place had its own
T T
ABL735 analyzer.
5-42
ABL800 FLEX reference manual 5. Performance characteristics
Field test results The field test results are given below.
(continued)
T
Regression table: Regression results from field tests. N = #samples, Sy/x is standard
B B
5-43
5. Performance characteristics ABL800 FLEX reference manual
250
200
ABL735
Syx=12.0
150
100
50
0
0 50 100 150 200 250 300
Hitachi, NIST
Actual field test from a neonatal critical care hospital using whole blood. Values
are in mol/L.
50
40
30
Difference
20
10
0
0 50 100 150 200 250 300
-10
-20
ctBil
5-44
ABL800 FLEX reference manual 5. Performance characteristics
Imprecision The following parameters are used to describe performance of the ABL835/30
parameters FLEX analyzers for bilirubin measurements.
S0:
B B Repeatability. Measurement short time interval variation on the same
sample
SD:
B B Day-to-day variation
ST:
B B Patient-to-patient variation
S I:
B B ABL-to-ABL instrumental variation
SABL:
B B ABL uncertainty. Variation including ST, SI and reference uncertainty
B B B B
SX:
B B Reproducibility. Total variation including S0, SD and SABL B B B B B B
The above field test regression statistics Syx include variations from S0, SD and ST.
B B B B B B B
(mol/L) (g/dL)
0 Plasma 1.1 1.4 2.2 0.4 2.3 2.9
0 10 100 1.9 3.1 4.0 3.2 5.1 6.3
0 15 100 2.3 2.9 7.4 5.5 9.2 9.9
0 20 100 3.4 2.6 10.9 13.0 17.0 17.5
200 Plasma 1.3 1.7 3.1 4.7 7.4 7.7
200 10 100 2.4 4.4 5.8 6.6 10.1 11.3
200 15 100 2.6 3.7 8.5 9.3 13.6 14.4
200 20 100 4.2 5.0 12.1 15.4 20.4 21.4
400 Plasma 1.7 2.5 4.8 9.3 12.0 12.3
400 10 100 3.5 6.8 9.3 12.0 16.5 18.2
400 15 100 3.4 5.3 11.4 15.9 20.8 21.7
400 20 100 6.0 8.8 15.0 21.0 27.1 29.2
Notes: a, b, c
5-45
5. Performance characteristics ABL800 FLEX reference manual
NOTES:
References 1. Fraser CG. The application of theoretical goals based on biological variation
data in proficiency testing. Arch Pathol Lab Med 1988; 112: 402-15.
2. Ehrmeyer SS, Laessig RH, Leinweber JE, Oryall JJ. 1990 Medicare/CLIA
final rules for proficiency testing: minimum intralaboratory performance
characteristics (CV and bias) needed to pass. Clin Chem 1990; 36, 10: 1736-
40.
5-46
ABL800 FLEX reference manual 5. Performance characteristics
References 3. Fraser CG, Petersen PH, Ricos C, Haeckel R. Proposed quality specifications
(continued)
T T for the imprecision and inaccuracy of analytical systems for clinical chemistry.
Eur J CLin Chem Clin Biochem 1992; 30: 311-17.
4. Westgard JO, Seehafer JJ, Barry PL. Allowable imprecision for laboratory test
based on clinical and analytical test outcome criteria. Clin Chem 1994; 40, 10:
1909-14.
5. Vanderline RE, Goodwine J, Koch D, Scheer D, Steindel S, Cembrowski G.
Guidelines for providing quality stat laboratory services. 1987 Laboratory
Quality Assurance Commitee.
5-47
5. Performance characteristics ABL800 FLEX reference manual
These special studies were conducted for each of the individual parameter profiles.
The parameters with the variation exceeding the Performance Characteristics are
listed below.
5-48
ABL800 FLEX reference manual 5. Performance characteristics
Overview
Introduction This chapter describes performance characteristics of the ABL8x7 FLEX analyzers
for each measured parameter and test conditions to obtain them.
5-49
5. Performance characteristics ABL800 FLEX reference manual
Test conditions
ABL8x7 Test conditions to determine biasABL and imprecision for pH, pCO2, pO2, cCa2+,
B B B B B B P P
Item Description
Reference analyzers Five ABL735 with AutoCheck module were used as a
reference. The C195 mode was used as a reference for
all measured parameters.
Primary reference As specified for each parameter further in this chapter.
methods
Analyzers and test Ten ABL837 were tested over 30 days in the
modes following modes:
Syringe: S250
Capillary: C125, C35 MET
Blood samples Heparinized blood samples from healthy, voluntary
donors.
The blood is prepared to obtain the different
concentration levels of each measured parameter.
Blood measurements The measurements were performed by different
operators.
Calibration solution and All calibration solutions and gases used for the tests
gases are traceable to Primary Reference Standards.
Traceability certificates for the ABL8x7 FLEX
calibration solutions and gases are found at the end of
chapter 7: Solutions.
T T
Test conditions for cCrea see pages 5-73 to 5-86 in this chapter.
T T
NOTES:
T
The solutions used in the performance tests are those recommended by
T
5-50
ABL800 FLEX reference manual 5. Performance characteristics
Reference
methods Parameter Reference method
pH Capillary-type glass pH electrode with a saturated
calomel reference electrode and a liquid junction
saturated with KCl (BMS Mk2) [1,2].
pCO2 and pO2
B B B B
Tonometry [3].
The gases used for tonometry are traceable to NIST-
certified Standard Reference Material SRM 1701a,
1702a, 1703a.
pH Bias
7.0 0.003
7.4 0.002
7.7 0.005
pH Bias
7.0 0.004
7.4 0.001
7.7 0.001
5-51
5. Performance characteristics ABL800 FLEX reference manual
(mmHg)
10 0.25 0.35 0.51 0.90
40 0.40 0.30 0.59 0.70
60 0.60 0.50 1.10 1.80
80 0.80 0.80 1.40 2.40
150 1.50 2.00 3.76 6.10
(mmHg)
10 0.38 0.40 0.80 1.40
40 0.60 0.45 0.85 1.80
60 0.90 0.75 1.60 2.70
80 1.20 1.20 2.01 3.60
150 2.70 1.20 4.83 7.40
5-52
ABL800 FLEX reference manual 5. Performance characteristics
pO2
B B S250 mode bias:
pO2 (mmHg)B B Bias
15 0.42
50 0.33
150 0.11
230 3.82
550 23.4
5-53
5. Performance characteristics ABL800 FLEX reference manual
Reference
methods Parameter Reference method
cK+, cNa+, cCl
T T P P T T P P T T P P The standard sodium and potassium solutions are
traceable to NIST-certified Standard Reference Material
SRM 909b (human serum)
cCa2+
T T P P Radiometer method used.
The standard calcium solutions used are validated
against corresponding NIST standard SRM 915 [4].
cK+
P P S250 mode bias:
5-54
ABL800 FLEX reference manual 5. Performance characteristics
cNa+
P P S250 mode bias:
cNa+ (mmol/L)
P P Bias
120 0.58
140 0.69
180 0.57
cNa+ (mmol/L)
P P Bias
120 0.43
140 0.03
180 0.41
5-55
5. Performance characteristics ABL800 FLEX reference manual
cCl
P P S250 mode bias:
5-56
ABL800 FLEX reference manual 5. Performance characteristics
cCa2+
P P S250 mode bias:
cCa2+ (mmol/L)
P P Bias
0.5 0.012
1.25 0.010
2.5 0.008
cCa2+ (mmol/L)
P P Bias
0.5 0.003
1.25 0.023
2.5 0.046
5-57
5. Performance characteristics ABL800 FLEX reference manual
Reference
methods Parameter Reference method
cGlu
T T Spectrophotometry, using the hexokinase (HK) method
recommended by NCCLS [5], measured on serum
cLac
T T Spectrophotometry using a lactate dehydrogenase (LDH) method,
measured on serum.
5-58
ABL800 FLEX reference manual 5. Performance characteristics
5-59
5. Performance characteristics ABL800 FLEX reference manual
Reference
method Parameter Reference method
ctHb
T T
HiCN method recommended by NCCLS [6].
(g/dL)
15 0 0.30 0.09 0.27 0.40
7 100 0.30 0.13 0.22 0.40
15 100 0.30 0.10 0.27 0.40
25 100 0.50 0.10 0.48 0.70
C125 bias:
ctHb (g/dL) sO2 (%)
B B Bias
15 0 0.19
7 100 0.08
15 100 0.12
25 100 0.11
(g/dL)
15 0 0.50 0.15 0.36 0.80
7 100 0.50 0.20 0.352 0.80
15 100 0.50 0.17 0.35 0.80
25 100 0.70 0.15 0.66 1.00
5-60
ABL800 FLEX reference manual 5. Performance characteristics
Explanation The optical system is unchanged in the ABL800 FLEX analyzers compared to the
ABL700 Series. Test of ctHb on the ABL800 FLEX analyzers has been conducted
T T
(results given on the previous page). The other oximetry parameters have not been
retested; the information and results below are from the ABL700 Series.
Reference
methods Parameter Reference method
Oximetry The reference method established for the oximetry
parameters uses modified ABL520 analyzers as the field
reference instruments. The ABL520 analyzers have been
validated and their performance specifications
determined according to primary reference methods.
The modified ABL520 analyzers are used in accordance
with IFCCs recommendations for traceability of
reference methods.
The reference methods used for the oximetry parameters
on the ABL520 analyzers are those presented below.
sO2
B B Tonometry: whole blood is tonometered with a gas
mixture containing 94.4 % O2 and 5.6 % CO2.
B B B B
dithionite.
FCOHb Gas chromatography. The standards are carbon
monoxide mixtures with atmospheric air, whose purity is
validated in accordance with NIST SRM 1678 (50 ppm
CO in N2).
B B
Test conditions
for oximetry Test Description
parameters Reference To verify that the correction constants have been
accurately determined, 10 analyzers with all parameters
available are tested in C195 mode against the reference
methods.
Each parameter is tested on 3-6 levels over at least three
days, with five repetitions each day.
(Five new analyzers with all parameters available were
tested against the reference methods for FHbF.)
Bias for each parameter in the C195 measuring mode
against the reference method is determined.
5-61
5. Performance characteristics ABL800 FLEX reference manual
Test conditions
for oximetry Test Description
parameters Verification 6-10 ABL700 Series analyzers are tested over at least 2
(continued)
T
days for all levels. Bias for the given mode is calculated
as difference compared to the C195 mode.
Bias against the reference method is determined as
follows:
Bias = bias against C195 + C195 bias against reference
method.
The following parameters: sO2, FCOHb, FMetHb and
B B
(g/dL)
15 0 0.50 0.12 0.60 1.00
7 100 0.30 0.15 0.42 0.60
15 100 0.30 0.15 0.45 0.60
25 100 0.50 0.16 0.67 1.00
5-62
ABL800 FLEX reference manual 5. Performance characteristics
sO2 (continued)
T T B B T T C125 bias:
ctHb (g/dL) sO2 (%)
B B Bias
15 0 0.04
7 100 0.14
15 100 0.12
25 100 0.13
(g/dL)
15 0 0.50 0.15 0.36 1.00
7 100 0.30 0.20 0.41 0.60
15 100 0.30 0.15 0.42 0.60
25 100 0.50 0.12 0.65 1.00
15 0 0.12
7 100 0.03
15 100 0.02
25 100 0.01
(g/dL)
15 0 0.05 0.05 0.25 0.30
7 100 0.25 0.20 0.50 0.60
15 100 0.15 0.15 0.45 0.50
25 100 0.10 0.10 0.40 0.45
5-63
5. Performance characteristics ABL800 FLEX reference manual
FO2Hb
T T B B C125 mode bias:
(continued)
FO2Hb (%) Bias
T
B B
15 0 0.02
7 100 0.39
15 100 0.40
25 100 0.46
(g/dL)
15 0 0.05 0.05 0.25 0.30
7 100 0.25 0.20 0.50 0.60
15 100 0.15 0.15 0.45 0.50
25 100 0.10 0.10 0.40 0.45
g/dL) (%)
15 100 0 0.05 0.10 0.35 0.40
7 100 20 0.10 0.10 0.75 0.80
15 100 20 0.05 0.10 0.70 0.75
25 100 20 0.05 0.10 0.70 0.75
5-64
ABL800 FLEX reference manual 5. Performance characteristics
FCOHb
T T C125 mode bias:
(continued)
T
g/dL) (%)
15 100 0 0.05 0.10 0.35 0.40
7 100 20 0.10 0.10 0.75 0.80
15 100 20 0.05 0.10 0.70 0.75
25 100 20 0.05 0.10 0.70 0.75
g/dL) (%)
15 100 0 0.10 0.10 0.25 0.30
7 100 20 0.05 0.10 0.35 0.40
5-65
5. Performance characteristics ABL800 FLEX reference manual
FMetHb
T T C125 mode bias:
(continued)
FMetHb (%) Bias
T
ctHb (g/dL)
T T sO2 (%)
B B FMetHb (%)
15 100 0 0.14
7 100 20 N/A
15 100 20 N/A
25 100 20 N/A
g/dL) (%)
15 100 0 0.10 0.10 0.25 0.30
7 100 20 0.05 0. 10 0.35 0.40
5-66
ABL800 FLEX reference manual 5. Performance characteristics
(%) (g/dL)
0 10 100 4 4 5 8
0 15 100 2 3 7 8
0 20 100 2 2 10 11
NOTES: a, b.
(%) (g/dL)
0 10 100 4 4 5 8
0 15 100 2 3 5 7
0 20 100 2 2 10 11
NOTES: a, b.
5-67
5. Performance characteristics ABL800 FLEX reference manual
(%) (g/dL)
0 10 100 4 5 5 9
0 15 100 3 3 6 8
0 20 100 2 3 6 7
NOTES: a, b.
(%) (g/dL)
0 10 100 4 5 6 9
0 15 100 3 3 6 8
0 20 100 2 3 6 7
NOTES: a, b.
5-68
ABL800 FLEX reference manual 5. Performance characteristics
Contribution to The following corrections should be geometrically added to SInst and SX for the B B B B
NOTES:
5-69
5. Performance characteristics ABL800 FLEX reference manual
Reference The standard bilirubin solution is traceable to Bechman C20 Standard Reference
method Material.
As the optical system is unchanged in the ABL8x7 FLEX analyzers compared to
the ABL700 Series, the specifications for bilirubin have not been re-established
see the description of bilirubin in section ABL8x0/8x5 Performance characteristics
T T
ctBil
T T S250 mode bias:
ctBil (mol/L) ctHb (g/dL) Bias
0 Plasma 0.7
0 15 6.6
0 20 9.9
400 Plasma 5.0
400 15 7.0
400 20 8.1
(mol/L) (g/dL)
0 Plasma 1.1 2.3 3.4 6.0
0 15 3.0 2.9 5.7 9.9
0 20 4.0 5.5 9.4 17.5
400 Plasma 2.5 2.5 11.6 16.0
400 15 6.0 5.0 14.6 21.7
400 20 9.0 10.0 17.7 29.2
Notes a, b, c.
5-70
ABL800 FLEX reference manual 5. Performance characteristics
(mol/L) (g/dL)
0 Plasma 1.1 2.3 3.4 6.0
0 15 3.0 2.9 5.8 9.9
0 20 4.0 3.0 11.3 17.5
400 Plasma 5.0 2.5 11.6 19.0
400 15 9.0 5.0 14.6 22.3
400 20 11.0 6.5 19.6 33.9
Notes a, b, c.
NOTES:
5-71
5. Performance characteristics ABL800 FLEX reference manual
Introduction This section describes performance characteristics for the cCrea parameter and
T T
Definitions The following terms are used to describe the performance specifications of the
ABL8x7 FLEX analyzers:
Term Definition
Repeatability The term "within-run imprecision" is identical to the ISO term
(within-run "repeatability", i.e. the closeness of the agreement between
precision) results of successive measurements of the same measurand
carried out under the same conditions of measurement [11].
Reproducibili- The ISO term "reproducibility" describes the closeness of
ty (total agreement of results of measurements under changed
imprecision) conditions. Reproducibility may include the following:
within-run imprecision, run-to-run imprecision, day-to-
day imprecision or/and "Instrument-to-instrument
imprecision" [11].
Sy/x
B B Standard Deviation about regression line
X Mean value
R Correlation coefficient (used in the second power: R2) P P
5-72
ABL800 FLEX reference manual 5. Performance characteristics
Samples
Preparation: Different experiments were made in order to investigate the
cCrea performance on the ABL837 FLEX analyzer under
different conditions.
The concentration of creatinine in the samples was reached by
spiking with a stock solution.
The samples used in these experiments were serum/plasma,
whole-blood or aqueous samples. Aqueous and serum/plasma
samples were spiked directly. Whole-blood samples were
prepared by separating the erythrocyte and plasma/serum layer.
The plasma/serum layer was then spiked and afterwards mixed
with erythrocyte layer. In order to reach different hematocrit
concentrations in the samples, different volumes of
plasma/serum and erythrocyte layer were mixed. Equilibrium
in the whole-blood samples was reached by gently mixing the
samples for 2 hours at room temperature.
The whole blood samples were prepared the day of the analysis
and not stored.
Storage of In order to prevent creatinine creatine equilibrium in the
serum/plasma serum/plasma samples, they were stored in the freezer at either
samples: 20 C or 80 C.
whole blood
The performance on whole-blood samples was tested during three days. Five
samples
whole-blood samples with different creatinine concentrations were prepared every
day. Each sample was measured five times in succession on nine ABL837 FLEX
analyzers see the table below.
Day cCrea(ABL837)
T T Repeatability Reproducibility* N
(mol/L) (CV%) (CV%)
1 87 1.3 3.6 45
1 320 1.4 2.5 45
1 566 1.2 2.5 45
1 1090 1.1 2.9 45
1 1575 1.0 3.3 45
2 55 1.1 4.6 45
2 252 1.0 2.5 45
2 538 1.1 2.7 45
2 1059 1.4 2.8 45
2 1575 1.4 3.4 45
3 59 1.5 3.7 45
5-73
5. Performance characteristics ABL800 FLEX reference manual
Performance
whole blood Day cCrea(ABL837)
T T Repeatability Reproducibility* N
samples (mol/L) (CV%) (CV%)
(continued)
T
3 267 1.5 2.8 45
3 543 1.4 3.0 45
3 1046 1.1 3.0 45
3 1548 1.4 3.1 45
* Reproducibility includes within-run and instrument-to-instrument imprecisions.
plasma samples
The precision performance on plasma samples was tested following the guidelines
described in CLSI EP5-A [13]. The performance was evaluated during 20 test days
where two separate runs (run = double determination) were performed each day on
three different plasma samples with normal, medium and high concentration of
creatinine, respectively. The study was performed on two ABL837 FLEX
analyzers see the table below.
Analyzer cCrea(ABL837)
T T Repeatability Reproducibility* N
(mol/L) (CV%) (CV%)
1 63 0.8 2.2 80
1 241 0.9 1.9 80
1 568 0.6 2.2 80
2 64 0.9 1.9 80
2 244 1.1 1.9 80
2 574 0.8 2.2 80
* Reproducibility includes within-run, run-to-run and day-to-day imprecisions.
quality control
The precision performance on S7835, S7845 and S7855 AutoCheck6+ solutions
was tested during a period of 24 days see the table below.
cCrea(ABL837)
T T Repeatability (CV%) Reproducibility* (CV%) N
(mol/L)
238 1.4 2.5 490
30 1.8 3.1 494
460 1.1 2.3 486
* Reproducibility includes within-run, run-to-run, day-to-day and instrument-to-
instrument imprecisions.
5-74
ABL800 FLEX reference manual 5. Performance characteristics
NIST 909b
Bias against the NIST 909b was determined as follows: two levels of NIST 909b
standards
were tested during one day in order to check the bias of the creatinine parameter.
The two levels of NIST 909b were prepared according to the recommended
procedure; each level was measured twice on 10 ABL837 FLEX analyzers see
the table below.
NIST 909b cCrea(ABL8x7)
T T Bias Repeatability Reproducibility* N
(mol/L) (mol/L) (%) (CV%) (CV%)
56.18 0.55 57.3 2.1 0.3 1.4 20
467.4 5.3 470.7 0.7 0.8 1.3 20
* Reproducibility includes within-run and instrument-to-instrument imprecisions.
Linearity The creatinine measurement on the ABL837 FLEX analyzer in whole blood has
been standardized towards serum/plasma creatinine because it is an established
international point of reference for predicate laboratory measurements of creatinine
in the clinical setting.
This has been done in two steps:
The relation between the used reference method, HPLC, and the ABL837 FLEX
analyzer has been established on both serum and plasma samples.
The relation between plasma and whole blood samples has been established on
the ABL837 FLEX analyzer.
Traceability between whole-blood measurements on the ABL837 FLEX analyzer
and serum/plasma measurements on the HPLC reference method has thereby been
established.
Linearity The primary working standards are prepared from NIST SRM 914a (creatinine)
reference and used to determine the creatinine concentration of seven serum pool standards
method and seven plasma standards. The measurements are performed using Reversed
Phase HPLC (High Performance Liquid Chromatography). The method has been
validated, using NIST SRM 909b (human serum).
serum samples
A serum pool was dialyzed in order to remove all creatinine and creatine, and
seven serum pool levels with different creatinine concentrations (25 to 1900
mol/L) and zero creatine were prepared. The seven serum pools were measured
on an HPLC reference method [12] and the mean values of the HPLC method were
used to assign reference values to seven serum pool levels. The linear response of
the cCrea(ABL8x7) was studied by performing measurements on the seven serum
T T
pool levels during three days. Three measurements were made on each level every
day on nine ABL837 FLEX analyzers. A total of 535 measurements were made.
5-75
5. Performance characteristics ABL800 FLEX reference manual
Linearity The cCrea results from the HPLC reference method and the ABL837 FLEX
T T
Regression Plot
cCrea(ABL837)
T T
(mol/L)
cCrea(HPLC) (mol/L)
T T
2
where Sy/x = 22.4 mol/L, R = 0.999, N = 535
B B P P
The Bias % Plot shows comparison of ABL837 and HPLC cCrea measurements. T T
cCrea(ABL8x7) cCrea(HPLC)
Bias = 100 (%)
cCrea(HPLC)
5-76
ABL800 FLEX reference manual 5. Performance characteristics
95 %
prediction
limits
cCrea(HPLC) (mol/L)
T T
plasma samples
A plasma pool was dialyzed in order to remove all creatinine and creatine, and
seven plasma pool levels with different creatinine concentrations (25 to 2000
mol/L) and zero creatine were prepared. The seven plasma pools were measured
on an HPLC reference method [12] and the mean values of the HPLC method were
used to assign reference values to seven plasma pool levels. The linear response of
the cCrea(ABL8x7) was studied by performing measurements on the seven plasma
T T
pool levels. Three measurements were made on each level on nine ABL837 FLEX
analyzers. A total of 184 measurements were made.
The cCrea results from the HPLC reference method and the ABL837 FLEX
T T
analyzer (see regression plot on the next page) show linear relationship.
5-77
5. Performance characteristics ABL800 FLEX reference manual
(mol/L)
cCrea(HPLC) (mol/L)
T T
2
where Sy/x = 16.6 mol/L, R = 0.999, N = 184
B B P P
The Bias % Plot shows comparison of ABL837 and HPLC cCrea measurements.T T
cCrea(ABL8x7) cCrea(HPLC)
Bias = 100 (%)
cCrea(HPLC)
5-78
ABL800 FLEX reference manual 5. Performance characteristics
plasma samples
(continued)
T T
Bias (%)
95 %
prediction
limits
cCrea(HPLC) (mol/L)
T T
whole blood
Whole-blood samples with different creatinine concentrations in the range of 41 to
versus plasma
1852mol/L were used. Each sample was measured as duplicate or triplicate on
ABL837 FLEX analyzers. The samples were then centrifuged. The plasma samples
thus obtained were also measured as duplicates or triplicates on the same ABL837
FLEX analyzers. This experiment was performed both internally at Radiometer
and externally at a hospital on patient samples.
Correlation between whole blood and plasma measurements on the ABL837 FLEX
analyzer is shown on the regression plot.
5-79
5. Performance characteristics ABL800 FLEX reference manual
T T
plasma), mol/L
The plot shows a small difference between results on whole blood and plasma
(linear relationship).
The ABL8x7 FLEX analyzers are designed to measure cCrea on whole blood. If
plasma, serum or NIST SRM is to be measured on the ABL8x7 FLEX analyzers,
cCrea can be corrected as follows:
cCrea(ABL8x7,plasma/serum) mol/L = 0.950 cCrea(ABL8x7,whole
T T T T
blood) 0.4
cCrea(ABL8x7,plasma/serum) mg/dL = 0.950 cCrea(ABL8x7,whole
T T T T
blood) 0.005
where cCrea(ABL8x7,whole blood) are the results obtained on the analyzer.
T T
linearity at
Seven levels of creatinine serum pool were prepared in order to test the effect of
various creatine
creatine concentrations on the linearity of the cCrea(ABL8x7).
concentrations
T T
For each creatinine level three samples with 0, 100 and 250 mol/L creatine,
respectively, were prepared by spiking. The samples without creatine were
prepared in order to obtain reference values (the same volume was added to these
samples as for the 100 and 250 mol/L creatine samples).
Each sample (three creatine levels and seven creatinine levels; 21 samples in total)
was measured three times on eight ABL837 FLEX analyzers every day over three
days. A total of 72 measurements were made on each sample.
5-80
ABL800 FLEX reference manual 5. Performance characteristics
Creatinine The cCrea (ABL837) results on samples with 100 mol/L creatine show linear
linearity at relationship.
various creatine
Regression Plot
concentrations
(continued)
T T
2
where Sy/x = 35.6 mol/L, R = 0.999, N = 492
B B P P
The cCrea(ABL837) results on samples with 250 mol/L creatine show linear
relationship (see the next page):
5-81
5. Performance characteristics ABL800 FLEX reference manual
2
where Sy/x = 35.6 mol/L, R = 0.999, N = 492
B B P P
concentration
Five samples with different hematocrit concentrations in the range of 20 to 70 %
were prepared. Each sample was measured three times on 10 ABL837 FLEX
analyzers see the table below.
5-82
ABL800 FLEX reference manual 5. Performance characteristics
The detection limit of the cCrea(ABL8x7) parameter was determined following the
T T
mol/L and creatine concentrations of 0, 50 and 125 mol/L were prepared. The
samples were then measured on seven ABL837 FLEX analyzers over two days.
Limit of Blank (LoB) was determined, using the following equation:
LoB = mean + 1.645 Standard Deviation at cCrea = 0 mol/L T T
Limit of Detection (LoD): The same procedure was followed to determine LoD
on samples with cCrea = 10 mol/L at 0, 50 and 125 mol/L creatine
T T
LoB N LoD N
(mol/L creatinine) (mol/L creatinine)
3.2 70 5.3 70
The LoD of the cCrea was found to be 5.3 mol/L on the ABL837 FLEX analyzer.
The LoQ (Limit of Quantitation) is the lowest actual amount of creatinine that can
be reliably detected (the LoD) and at which the total error meets the requirements
(acceptable for clinical use). So if the total error of the measurement used in the
LoD study is acceptable, then LoQ = LoD.
The total analytical error is determined using the following equation:
Total Error = (|Bias| + 2 Standard Deviation)
The table below shows the cCrea(ABL8x7) results for samples with creatinine at
T T
10 and 25 mol/L:
Level Bias SD Total Error N
(mol/L) (mol/L) (mol/L) (mol/L)
10 1.7 1.3 4.4 70
25 1.7 1.5 4.7 67
5-83
5. Performance characteristics ABL800 FLEX reference manual
Detection limit The total Error of cCrea measurements on the ABL837 FLEX analyzer for the
(continued)
T T
LoD study (cCrea = 10 mol/L) is acceptable for clinical use and the limit of
T T
The lower detection limit of the ABL8x7 FLEX analyzer was set at 10 mol/L
creatinine; the values lower than 10mol/L will not be reported by the analyzer.
study (serum) In order to compare repeatability and bias of the cCrea(ABL8x7) parameter with
T T
enzymatic an enzymatic laboratory routine method, the guideline CLSI EP9-A [15] was
method followed.
In the study performed at a university hospital in Denmark, the enzymatic method
of COBAS Integra 700 from Roche (called Integra for short) was used as the
comparative method. 104 patient (serum) samples (CLSI recommends a minimum
of 40 samples) in a clinically significant range of 15-1263 mol/L were collected.
The samples were measured twice by both methods.
From duplicate 104 patient samples covering the range 15-1263 mol/L creatinine,
statistical calculation of repeatability was made for the Integra and the ABL837
FLEX analyzer:
Method Repeatability (CV%) N (number of duplicates)
Integra 1.5 104
ABL837 2.8 104
(meas1 - meas2) 2
Standard Deviation = 1
2N
where meas1 and meas2 are two measurements on the same sample, i.e. duplicates.
The regression plot (see the next page) describes the relationship between
cCrea(ABL8x7) and cCrea(Integra).
T T T T
5-84
ABL800 FLEX reference manual 5. Performance characteristics
method (mol/L)
(continued)
T T
cCrea(Integra) (mol/L)
T T
The Bias % Plot (see the next page) shows comparison of the cCrea(ABL8x7) and T T
cCrea(Integra).
T T
cCrea(ABL8x7) cCrea(Integra)
Bias = 100 (%)
Mean (cCrea(ABL8x7) + cCrea(Integra) )
5-85
5. Performance characteristics ABL800 FLEX reference manual
95 %
prediction
limits
Note that the results outside the prediction limits in the low concentration range
correspond to cCrea values of 20-30 mol/L.
T T
study (serum) In order to compare repeatability and bias of the cCrea (ABL8x7) parameter with a
T T
Jaff method Jaff laboratory routine method, the guideline CLSI EP9-A [15] was followed.
In the study performed at a university hospital in Denmark, the Jaff-rate blank
method of Modular from Roche (Hitachi instrument with Boehringer Manheim kit)
called Modular for short was used as the comparative method. 54 patient
(serum) samples (CLSI recommends a minimum of 40 samples) in a clinically
significant range of 21-1263 mol/L creatinine were collected. The samples were
measured twice by both methods.
From duplicate 54 patient samples covering the range 21-1263 mol/L creatinine,
statistical calculation of repeatability was calculated for the Modular and the
ABL837 FLEX analyzer:
Method Repeatability (CV%) N (number of duplicates)
Modular 1.4 54
ABL837 2.5 54
5-86
ABL800 FLEX reference manual 5. Performance characteristics
(meas1 - meas2) 2
Standard Deviation = 1
2N
where meas1 and meas2 are measurements on the same sample, i.e. duplicates.
The Regression Plot below describes the relationship between cCrea(ABL8x7) and
T T
cCrea(Modular).
T T
Regression Plot
T cCrea(ABL837)
T
(mol/L)
cCrea(Modular) (mol/L)
T T
5-87
5. Performance characteristics ABL800 FLEX reference manual
study (serum)
cCrea(ABL8x7) = 1.154 cCrea(Modular) 33.2
Jaff method
T T T T
(continued)
T T where Sy/x = 15.8 mol/L, R2 = 0.999, N = 108
B B P P
cCrea(Modular).
T T
cCrea(ABL8x7) cCrea(Modular)
Bias = 100 (%)
Mean (cCrea(ABL8x7) + cCrea(Modular))
Bias % Plot
Bias (%)
95 %
prediction
limits
study whole In order to compare repeatability and bias of the cCrea(ABL8x7) parameter with a T T
blood whole blood creatinine method, the guideline CLSI EP9-A [15] was followed.
In the study performed at a hospital in the USA, the i-STAT creatinine cartridges
were used as the comparative method. 55 patient (heparinized whole blood)
samples (CLSI recommends a minimum of 40 samples) in a clinically significant
range of 44-1743 mol/L were collected. The samples were measured twice by
both methods.
5-88
ABL800 FLEX reference manual 5. Performance characteristics
Comparison From duplicate 55 patient samples covering the range 44-1743 mol/L creatinine,
study whole statistical calculation of repeatability was calculated for the i-STAT and the
blood ABL837 FLEX analyzer:
(continued)
T
(meas1 - meas2) 2
Standard Deviation = 1
2N
where meas1 and meas2 are measurements on the same sample, i.e. duplicates.
The Regression Plot below describes the relationship between cCrea(ABL8x7) and
T T
cCrea(i-STAT).
T T
Regression Plot
cCrea(ABL837)
T T
(mol/L)
cCrea(i-STAT) (mol/L)
T T
5-89
5. Performance characteristics ABL800 FLEX reference manual
study whole
cCrea(ABL8x7) = 0.990 cCrea(i-STAT) 18.5
blood
T T T T
(continued)
T T where Sy/x = 38.2 mol/L, R2 = 0.997, N = 110
B B P P
The Bias % Plot below shows comparison of the cCrea(ABL8x7) and cCrea(i- T T T T
STAT).
cCrea(ABL8x7) cCrea(i - STAT)
Bias = 100 (%)
Mean (cCrea(ABL8x7) + cCrea(i - STAT) )
Bias % Plot
Bias (%)
95 %
prediction
limits
Item Description
Primary reference Reverse Phase HPLC
method
Analyzers and test 10 ABL837 were tested over three days in the following
modes modes:
syringe S250
capillary C125
5-90
ABL800 FLEX reference manual 5. Performance characteristics
Imprecision
(continued)
T
Item Description
Blood samples Heparinized blood from healthy voluntary donors.
Five blood pools were prepared to cover the test range.
Blood The measurements were performed by different operators
measurements
Calibration All calibration solutions and gases used for the tests are
solution and gases traceable to Primary Reference Standards.
Traceability certificates for the ABL800 FLEX calibration
solutions and gases are found at the end of chapter 7:
Solutions.
T T
S250 mode:
cCrea (mol/L) S0B B SDB B SABL
B B SX
B B
C125 mode:
cCrea (mol/L) S0B B SDB B SABL
B B SX
B B
5-91
5. Performance characteristics ABL800 FLEX reference manual
Interference tests
pH/blood gas The following interference results are found for the pH and blood gas electrodes:
Electrolytes The following interference results are found for the electrolyte electrodes:
Interference on
Substance Test conc. cK+
T T P P cNa+
T T P P cCa2+
T T P P
cCl
T T P P
Li+ P P 4 mmol/L 0 0 0
K+ P P 12 mmol/L 1 0.01
Na+ P P 100-180 0.1 to 0.1
mmol/L
NH4+ B PB P 1 mmol/L 0 0
Ca2+ P P 5 mmol/L 0
Mg2+ P P 5 mmol/L 0 0 0.05
Br P P 10 mmol/L 41
F P P 1 mmol/L 0
I
P P 3.0 mmol/L 30-90
ClO4 B PB P 1.5 mmol/L 8-30
HCO3 B PB P 25-50 mmol/L 0.1 mmol/L Cl P P
per mmol/L
HCO3 B PB P
Lactate 10 mmol/L 0
Continued on next page
5-92
ABL800 FLEX reference manual 5. Performance characteristics
Electrolytes T
(continued)T
Interference on
Substance Test conc. cK+
T T P P cNa+
T T P P cCa2+
T T P P
cCl
T T P P
Acetyl- 3.0 2
salicylic mmol/L
acid
Salicylic 4.0 7
acid mmol/L
Ascorbic 1.0 0
acid mmol/L
pH 7.2 7.2 0 0 0.01 1
pH 7.6 7.6 0 0 0.01 1
Glucose and The following interference results are found for the Glucose and Lactate
Lactate electrodes:
Interference on
Substance Test conc. cGlucose
T T TcLactate
T
5-93
5. Performance characteristics ABL800 FLEX reference manual
Glucose and
LactateT
Interference on
(continued)T
Substance Test conc. cGlucose T T cLactate
T T
cLactate % at :
T T
5-94
ABL800 FLEX reference manual 5. Performance characteristics
Oximetry The substances against which the oximetry parameters (ctHb, sO2, FO2Hb, T T B B B B
parameters FCOHb, FMetHb, FHHb, FHbF) and ctBil were tested for interference are given T T
Change on
Substance Test conc. TctHb
T sO2
T T B B FO2Hb
T T B B FCOHb
T T FMetHb
T T FHHb
T T FHbF
T T T TctBil T T
Intralipid 4 Vol % e) P P
0.5 0.1 1.3 0.5 0.9 0.1 11 0
b)
4 P P
f)
Intralipid 2 Vol % P P
0.4 0.1 0.3 0.3 0.1 0.1 11 7
2 b) P P
HbF a), c)
P P 20 % P P
0.02 1.17 0.04 0.73 0.37 1.14 0 14
SHb
T T 10 % 0 1.0 0.9 0.1 0.1 0.9 Not tested
pH 7.1 0.5 0.5 0.2 0.4 0.1 0.5 19 0
7.9 0.6 0.6 0.5 1.0 0.1 0.6 13 5
Cardio Green c) P P 5 mg/L 0.16 0.29 1.14 0.07 0.93 0.29 5 20
Evans Blue c) P P 5 mg/L 0.04 0.14 0.28 0.20 0.20 0.14 5 5
Betacarotene in 3.7 mol/L 0.0 0.02 0.03 0.01 0.04 0.02 0.1 0.2
c)
plasma P P
Notes: a) If function "Correction for HbF" is not activated, the change is 0 for all parameters.
b) Plasma sample.
c) Calculated value from mathematical superposition of measured pure interference
spectrum on measured reference spectrum.
d) ctBil = 400 mol/L.
T T
5-95
5. Performance characteristics ABL800 FLEX reference manual
Contribution to The process of HbF correction introduces additional noise compared to measure-
imprecision ment on adult samples. The following tables list the extra contribution which must
specifications be added geometrically to the imprecision specifications for adult samples in order
from HbF to obtain the imprecision specifications for fetal samples (also for adult samples if
correction function Correction for HbF levels less than 20 % is activated).
S fetal = S adult
2
+ S HbF
2
; geometrical addition of imprecision
where Sfetal is the calculated fetal imprecision; Sadult is the corresponding adult
B B B B
imprecision; SHbF is the extra contribution from HbF correction which is listed in
B B
sO2 %
B B 0.15 0.20 0.19 0.31
FHHb % 0.14 0.19 0.19 0.30
FO2Hb %B B 0.01 0.01 0.01 0.01
FCOHb % 0.09 0.13 0.12 0.20
FMetHb % 0.05 0.06 0.06 0.10
sO2 %
B B 0.09 0.12 0.29 0.33
FHHb % 0.09 0.11 0.28 0.32
FO2Hb %B B 0.00 0.00 0.01 0.01
FCOHb % 0.06 0.07 0.18 0.21
FMetHb % 0.03 0.04 0.09 0.11
sO2 %
B B 0.09 0.12 0.20 0.25
FHHb % 0.09 0.11 0.19 0.25
FO2Hb %B B 0.00 0.00 0.01 0.01
FCOHb % 0.06 0.07 0.13 0.16
FMetHb % 0.03 0.04 0.06 0.08
5-96
ABL800 FLEX reference manual 5. Performance characteristics
FHbF sensitivity FHbF is sensitive to pH deviations from the nominal value of pH = 7.4. If pH is
for pH changes T T
converted into cH+ (hydrogen ion concentration), the relationship between the
T T P P
changes in cH+ and FHbF is linear as seen from the following equation:
T T P P
ctBil sensitivity
T T
MCHC (Mean Corpuscular Hemoglobin Concentration) is used to estimate
for MCHC hematocrit, Hct, which is used in the ctBil measurement. MCHC is an average Hb
T T
variations concentration in the red blood cell (RBC). If the RBC volume decreases, MCHC
increases. If an RBC has iron deficit, MCHC decreases.
Hct is determined from ctHb as follows:
ctHb
Hct =
MCHC
A standard value of 332 g/L is assumed for MCHC which gives
Hct = ctHb 0.0301 if the unit for ctHb is g/dL.
MCHC can, however, deviate from this standard value as illustrated in the
following table (see the next page).
Erythrocytometric values given for apparently healthy white and black subjects
of different ages are taken from: Geigy Scientific Tables, Physical Chemistry,
Composition of Blood, Hematology, Somametric Data, CIBA-GEIGY, 1984; 3,
207.
5-97
5. Performance characteristics ABL800 FLEX reference manual
ctBil sensitivity
T T Subjects Age Hct Hct MCHC MCHC
for MCHC mean 95 % range mean, g/L 95 % range,
variations T
g/L
(continued) T
If MCHC is defined as MCHC = 332 g/L MCHC, then the contribution to the
relative error on the ctBil measurement is as follows:
T T
5-98
ABL800 FLEX reference manual 5. Performance characteristics
variations T
(continued) T
If the reference value for Hct is known, it is possible to correct the displayed ctBil T T
ctBil sensitivity
T T ctBil is slightly sensitive to pH deviations from the nominal value of pH = 7.4.
T T
for pH changes
The following table shows the changes in ctBil compared to the value at pH = T T
7.4.
Sample Type ctHb
T T
Nominal ctBil
T T ctBil
T T
g/dL ctBil
T T
(7.47.1) (7.47.9)
mol/L mol/L mol/L
Adult/fetal plasma 0 0 3 0
Adult blood, sO2 = 100 % B B 15 0 0 5
Fetal blood, sO2 = 100 % B B 15 0 13 4
Adult/fetal plasma spiked with 0 400 2 1
unconjugated bilirubin
Adult/fetal plasma spiked with 0 400 9 11
conjugated bilirubin
Adult blood spiked with un- 15 400 10 26
conjugated bilirubin, sO2 = 100 % B B
5-99
5. Performance characteristics ABL800 FLEX reference manual
Creatinine Stock solutions of the tested interference were prepared in concentrations 20 times
(continued)
T T the test concentration on the day of the analysis.
Prior to measurement, one serum sample was spiked with the interference stock
solution (sample T) and another serum sample was spiked with the same volume of
the diluent used to prepare the stock solution (sample C).
The test of interferences was then performed as relative measurements. The sample
with the tested interference (T) was compared to the control sample (C) measured
at the same time: C1T1C2T2C3T3. Each sample was measured three times. The aim
B B B B B B B B B B B B
to 92 mol/L.
5-100
ABL800 FLEX reference manual 5. Performance characteristics
Creatinine
(continued)
T
Substance Test concentration Interference (mol/L)
Dobutamine 10 g/L < |8|
Dopamin 5.9 mol/L < |8|
Doxycycline 67.5 mol/L < |8|
Ethanol 86.8 mmol/L < |8|
Fluoride 50 mmol/L < |8|
Gentisic acid 117 mol/L < |8|
Glutamate sodium salt 2 g/L < |8|
Gluthation oxidized 10 mg/L < |8|
Gluthation reduced 10 mg/L < |8|
HCO3B PB P 40 mmol/L < |8|
Heparin (Li-salt) 80000 U/L < |8|
Hepes 20 mmol/L < |8|
Hemoglobin 10 % hemolysis < |8|
Hemoglobin 3.5 % hemolysis < |8|
Hydroxyurea 100 mol/L < |8|
Ibuprofen 2.4 mmol/L < |8|
Intralipid 5% < |8|
Intralipid 2.5 % < |8|
L-DOPA 20 mol/L < |8|
L(+)-Glucose 60 mmol/L < |8|
Lithium nitrate 3.2 mmol/L < |8|
L-Lactic acid 30 mmol/L < |8|
L-Prolin 250 mol/L < |8|
Lidocaine hydrochloride 100 mol/L < |8|
Lidocaine powder 98 % 100 mol/L < |8|
6-Mercaptopurine (13.1 mmol/L)* < |8|
Magnesium nitrate 3 mmol/L < |8|
Methotrexate 2.0 mmol/L < |8|
*Saturated stock solution
5-101
5. Performance characteristics ABL800 FLEX reference manual
Creatinine
(continued)
T
Substance Test concentration Interference (mol/L)
Methyldopa 71 mol/L < |8|
Oxo-(2)-butyric acid 5 mmol/L < |8|
Paracetamol (acetaminophen) 1.7 mmol/L < |8|
pH 8.0 < |8|
pH 6.0 < |8|
Phenylbutazone 325 mol/L < |8|
Pyruvate 3 mmol/L < |8|
Rifampicin 78.1 mol/L < |8|
Sarcosine 1 mol/L < |8|
Sodium hydrogen carbonate 40 mmol/L < |8|
Sodium hydrogen phosphate 2 mmol/L < |8|
Theopyllin 222 mol/L < |8|
Theophyllin acetic acid 200 mol/L < |8|
Thiocyanate 24 mmol/L < |8|
Urea 50 mmol/L < |8|
Uric acid 3 mmol/L < |8|
5-102
ABL800 FLEX reference manual 5. Performance characteristics
References
5-103
5. Performance characteristics ABL800 FLEX reference manual
5-104
6. 6. Parameters
Overview
Introduction The measured, input and derived parameters are described in this chapter.
6-1
6. Parameters ABL800 FLEX reference manual
General information
The Deep The Deep Picture developed by Radiometer [1], (visit our website www.deep- H
Picture picture.com), expands traditional pH and blood gas analysis by evaluating the
H
capability of arterial blood to carry sufficient oxygen to tissues and to release it. It
simplifies interpretation by dividing the process into three stages:
Stage Description
Oxygen Oxygen uptake in the lungs indicates whether the pulmonary gas
uptake exchange is efficient enough to oxygenate arterial blood.
The uptake of oxygen in the lungs can be described by parameters
in combination, primarily the arterial oxygen tension (pO2(a)), B B
perfused blood (Qs/Qt) B B B B
FMetHb(a)).
Oxygen Oxygen release describes the ability of arterial blood to release
release oxygen to the tissues.
The release of oxygen from capillaries to tissues is determined by
the oxygen tension gradient between the two. This release of
oxygen is also influenced by the hemoglobin-oxygen affinity,
which is indicated by the oxygen tension at 50 % saturation, p50.
Symbols The symbols for the parameters are based on the principles described by Wandrup [2].
Each symbol consists of three parts, described below: T
1. Property
T T A symbol in italics p for pressure
T T
F for fraction
T T
V for volume
T T
etc.
2. Component An abbreviation of the O2 for oxygen B B
6-2
ABL800 FLEX reference manual 6. Parameters
Symbols
(continued) 3. (System) Specification of the system B for blood
P for plasma
T
component
Example:
T
T pO2(a)
T B B
property system
The parameters are listed by symbol in three groups: measured, input and derived.
Measuring The measuring range for a parameter is the range within which the
analyzer is physically capable of measuring. The measuring range
corresponds to the "range of indication" as defined in the
"International vocabulary of basic and general terms in metrology"
(VIM).
Reportable Is user-defined; is equal to or narrower than the measuring range.
Can be selected for all measured and derived parameters.
Reference "Reference ranges are valuable guidelines for the clinician, but they
should not be regarded as absolute indicators of health and disease.
Reference ranges should be used with caution since values for
healthy individuals often overlap significantly with values for
persons afflicted with disease. In addition, laboratory values may
vary significantly due to methodological differences and mode of
standardization" [10].
Ref. 10 has been the source for the reference ranges given in this
section. In some cases the values are taken from other sources
marked by their reference number.
When possible, the reference ranges for arterial blood have been
listed. Reference ranges must be used with caution as they depend on
a number of factors, such as sex, age and normal physiological
condition.
Critical limits are user-defined and can be entered into the analyzer software see
chapter 3: Setup Programs (section Analysis Setup) in the Operators Manual.
T T T T
6-3
6. Parameters ABL800 FLEX reference manual
If one or more default values have been used in the calculation, the result may
deviate significantly from the true value. The deviation on estimated oxygen status
parameters may become particularly significant if default values are used instead of
measured blood oximetry data.
In some cases, however, the default value is not accepted as the input for the
calculation. This is because the actual values of the missing parameter may deviate
significantly from the default value, thus making the estimation clinically
inappropriate. If sO2 cannot be measured due to severe errors, it will be calculated.
B B
Measured Some of the listed parameters are measured, depending on the analyzer
parameters configuration. In these cases the equation given only applies if that parameter is
not directly measured by the analyzer.
T T
Sample type Unless otherwise stated, a parameter will be calculated or estimated irrespective of
the choice on the Patient Identification screen: "Arterial", "Capillary", "Venous",
T T
"Mixed venous", or "Not specified". Some parameters, however, are defined for
arterial samples only; they will be calculated only for sample types entered as
"Arterial" or "Capillary".
The symbol for system (blood (B) or plasma (P)) is not stated in the equations
unless it is important for the calculation.
Units The units given for each parameter refer to the units available on the analyzer for that
parameter.
Default values The default values are listed in Default Values at the end of this chapter.
T T
6-4
ABL800 FLEX reference manual 6. Parameters
Measured parameters
pH
Definition Indicates the acidity or alkalinity of the sample
Unit -
Measuring range 6.300-8.000
Reference range 7.35-7.45 (m, f)
cH+
Definition Concentration of hydrogen ions in blood
T T P P
Unit nmol/L
Measuring range 10.0-501
Reference range 35.5-44.7 (m, f)
6-5
6. Parameters ABL800 FLEX reference manual
pCO2
Measuring range mmHg; torr: 5.0-250
T T B B
(continued)
T
kPa: 0.67-33.3
Reference range mmHg: 35-48 (m); 32-45 (f)
kPa: 4.67-6.40 (m); 4.27-6.00 (f)
Conversion of units p (kPa) = 0.133322 p(mmHg) = 0133322
. p (torr)
p (mmHg) = p (torr) = 7.500638 p (kPa)
Baro
T Definition Ambient barometric pressure (p(amb))
T T
6-6
ABL800 FLEX reference manual 6. Parameters
sO2
B B Can also be calculated.
Definition Oxygen saturation, the ratio between the concentrations
of oxyhemoglobin and the hemoglobin minus the
dyshemoglobins
Unit %; fraction
Measuring range %: 0.0-100.0
Fraction: 0.000-1.000
Reference range %: 95-99 (m, f)
Fraction: 0.95-0.99 (m, f)
6-7
6. Parameters ABL800 FLEX reference manual
sO2 (continued)
Reference Siggaard-Andersen O, Wimberley PD, Fogh-Andersen
T T B B T
S (1 FMetHb) FCOHb
sO 2 =
1 - FCOHb - FMetHb
where
S = ODC(P,A,T) T T
pO 2 FCOHb
P = pO 2 +
sO 2 (1 FCOHb FMetHb)
A=a
T = 37.0 oC
T T P P
6-8
ABL800 FLEX reference manual 6. Parameters
6-9
6. Parameters ABL800 FLEX reference manual
FHHb
Equation FHHb = 1 sO2 (1FCOHbFMetHb)FCOHb
T T
(continued) B B
FMetHb
T
equation 39.
If dyshemoglobins (FCOHb, FMetHb) are not known,
they are set to the default values.
cK+
T T P P Definition Concentration of potassium ions in plasma
Unit mmol/L; meq/L
Measuring range mmol/L; meq/L: 0.5-25.0
Reference range m, f: 3.4-4.5 mmol/L
Conversion of units mmol/L = meq/L
6-10
ABL800 FLEX reference manual 6. Parameters
cCa2+
T T P P Definition Concentration of calcium ions in plasma
Unit mmol/L; meq/L; mg/dL
Measuring range mmol/L: 0.20-9.99
meq/L: 0.40-19.98
mg/dL: 0.80-40.04
Reference range m, f: 1.15-1.29 mmol/L; 2.30-2.58 meq/L
Conversion of units meq/L = 2 mmol/L
mg/dL = 4.008 mmol/L
Reference Siggaard-Andersen O, Thode J, Wandrup JH. The
concentration of free calcium ions in the blood plasma
ionized calcium. In: Siggaard-Andersen O, ed.
Proceedings of the IFCC expert panel on pH and blood
gases held at Herlev Hospital 1980, Copenhagen:
Radiometer Medical A/S, 1981: 163-90. Available as
AS79.
cGlu
T T Definition Concentration of D-glucose in plasma
Unit mmol/L; mg/dL
Measuring range mmol/L: 0.0-60
mg/dL: 0-1081
Reference range m, f: 3.89-5.83 mmol/L; 70-105 mg/dL
Conversion of units cGlucose (mg/dL) = 18.016 cGlucose (mmol/L)
T T T T
6-11
6. Parameters ABL800 FLEX reference manual
cLac
T T Definition Concentration of L-lactate in plasma
Unit mmol/L; meq/L; mg/dL
Measuring range mmol/L: 0.0-30
meq/L: 0.0-30
mg/dL: 0-270
Reference range m, f: 0.5-1.6 mmol/L; 4.5-14.4 mg/dL
Conversion of units cLactate (mg/dL) = 9.008 cLactate (mmol/L)
T T
ctBil
T T Definition Concentration of total bilirubin in plasma
Total bilirubin includes its two forms: conjugated and
unconjugated.
Unit mol/L; mg/dL; mg/L
Measuring range mol/L: 0-1000
mg/dL: 0.0-58.5
mg/L: 0-585
Reference range See the table on the next page.
Conversion of units ctBil (mol/L) = 17.1 ctBil (mg/dL)
T T
6-12
ABL800 FLEX reference manual 6. Parameters
Age ctBil
T T
T cCrea
T Definition Concentration of creatinine in blood
Unit mol/L; mg/dL
Measuring range mol/L: 10-1800
mg/dL: 0.11-20.4
Reference range m: 53-106 mol/L, 0.6-1.2 mg/dL
f: 44-97 mol/L, 0.5-1.1 mg/dL
Conversion of units cCrea (mol/L) = 88.40 cCrea (mg/dL)
T T
6-13
6. Parameters ABL800 FLEX reference manual
Input parameters
Definition Input parameters are the parameters keyed in by the operator on the Patient T
T
Definition Patient temperature
T
o
Unit P C; oF
P P P
o
Measuring range P C: 15.0-45.0
P
o
P F: 59-113
P
Conversion 9 o 5
T F = T C + 32 ; T C = (T oF 32)
5 9
T T T T
FO2(I)
Definition Fraction of oxygen in dry inspired air
B B
Unit %; fraction
Input range %: 0-100
fraction: 0.000-1.000
Reference range 35.5-44.7 (m, f)
6-14
ABL800 FLEX reference manual 6. Parameters
pO2(v ) B B
Definition Oxygen tension of mixed venous blood
Input range/Unit mmHg; torr: 0.0-750.0
kPa: 0.00-100
Conversion p(kPa) = 0.133322 p(mmHg)
T T T T
sO2(v ) B B
Definition Oxygen saturation of mixed venous blood
Input range/Unit %: 0.0-100.0
fraction: 0.000-1.000
VO2 B B
Definition Oxygen consumption; total amount of oxygen
utilized by the whole organism per unit of time
Input range/Unit mL/min: 0-xxxx
mmol/min: 0.0-xxx.x
Conversion (mmol/L)min = (mL/dLmin)/22.41
VCO
Definition Volume of carbon monoxide added to the patient
for measurement and calculation of V(B) [5]
Input range/Unit 0.0-1000.0 mL
6-15
6. Parameters ABL800 FLEX reference manual
pH = 7.40
pCO2 = 5.33 kPa
B B
FCOHb(1)
Definition The fraction of COHb measured before the CO-
injection
Input range/Unit %: 0.0-100.0
fraction: 0.000-1.000
FCOHb(2)
Definition The fraction of COHb measured after the CO-
injection
Input range/Unit %: 0.0 - 100.0
fraction: 0.000 - 1.000
6-16
ABL800 FLEX reference manual 6. Parameters
Derived parameters
information
ms for measured parameters
dv for derived parameters
Acid-base
derived Symbol Definition Type Eq.
parameters pH(T) T T pH of blood at patient temperature. dv 1
T T
patient temperature.
pCO2(T) B B T T Partial pressure (or tension) of carbon dioxide at dv 3
T T
patient temperature.
cHCO3(P) B PB P Concentration of hydrogen carbonate in plasma dv 4
T T
cBase(Ecf)
T T Standard Base Excess, an in vivo expression of dv 7
T T
ctCO2(P)
T T B B Concentration of total carbon dioxide, (free CO2 B B dv 10
T T
6-17
6. Parameters ABL800 FLEX reference manual
Acid-base
derived Symbol Definition Type Eq.
parameters ctCO2(B)
T T B B Concentration of total carbon dioxide in whole dv 11
T T
(continued)
T
blood (also termed CO2 content).
B B
air)
Oximetry
derived Symbol Definition Type Eq.
parameters FHHb Fraction of deoxyhemoglobin in total hemoglobin ms/dv 41
T T
in blood.
Deoxyhemoglobin is the part of total hemoglobin
which can bind oxygen forming oxyhemoglobin.
It is also termed reduced hemoglobin, RHb.
FO2Hb B B Fraction of oxyhemoglobin in total hemoglobin in ms/dv 40
T T
blood.
sO2 B B Oxygen saturation, the ratio between the ms/dv 39
T T
6-18
ABL800 FLEX reference manual 6. Parameters
Oxygen derived
parameters Symbol Definition Type Eq.
pO2(T) B B T T Partial pressure (or tension) of oxygen at patient dv 14
T T
temperature.
pO2(A) B B Partial pressure (or tension) of oxygen in dv 15
T T
alveolar air.
pO2 (A,T) B B T T Partial pressure (or tension) of oxygen in dv 16
T T
FO2(I)
T T B B fraction of oxygen in dry inspired air
pO2(a,T)/ B B T T Oxygen tension ratio of arterial blood at patient dv 18
T T
FO2(I)
T T B B temperature and the fraction of of oxygen in
dry inspired air
p 50
T T Partial pressure (or tension) of oxygen at half dv 19
T T
pH = 7.40
pCO2 = 5.33 kPa
B B
6-19
6. Parameters ABL800 FLEX reference manual
Oxygen derived
parameters Symbol Definition Type Eq.
(continued)
T
pO2(a/A) B B Ratio of the partial pressure (or tension) of dv 24
T T
FO2(I)
T T B B Fraction of oxygen in dry inspired air. in
6-20
ABL800 FLEX reference manual 6. Parameters
Oxygen derived
parameters Symbol Definition Type Eq.
(continued)
T
FShunt
T T Relative physiological shunt or concentration- dv 34
T T
air)
Qx B B Cardiac oxygen compensation factor of arterial dv 38
T T
V(B)
T T Volume of blood, calculated when FCOHb and dv 42
T T
if non AA American
6-21
6. Parameters ABL800 FLEX reference manual
Calculated Derived parameters are calculated or estimated on the basis of measured and
versus estimated keyed-in data. Calculations are made using equations programmed into the
parameters analyzer. The accuracy of the calculations depends on the input parameters keyed
into the analyzers computer.
If the calculation of a parameter requires input from the operator, but this input is
not forthcoming, the analyzer will use certain default values (refer to the section
Default Values in this chapter).
T T
Not all input parameters are stored as defaults. In these instances the dependent
derived parameter will not be reported if the relevant input parameter(s) is/are not T T
entered.
If the default values are used in the calculation of a parameter, then a parameter is
considered estimated ("e") rather than calculated ("c").
T T T T
Acid-base The ABL83x FLEX analyzer corresponds to ABL82x FLEX analyzer, but it can
parameters measure ctBil and FHbF.
T T
+
cH (T)
T T P P T T nmol/L .x c c c T
T T
pCO2(T) B B T T mmHg; .x c c c T
T T
torr
kPa .xx
cHCO3(P) B PB P mmol/L .x c c c
cBase(B)
T T mmol/L Range c c c ctHb
30.0 e c c
cBase(B,ox)
T T mmol/L .x e c c ctHb
e c c
cBase(Ecf)
T T mmol/L Range c c c
30.0
cBase(Ecf,ox)
T T mmol/L .x e c c
cHCO3(P,st) B PB P mmol/L .x c c c ctHb
e c c
6-22
ABL800 FLEX reference manual 6. Parameters
Acid-base The ABL83x FLEX analyzer corresponds to ABL82x FLEX analyzer, but it can
parameters measure ctBil and FHbF.
T T
(continued)
Number of characters before "." is variable; number of decimals is constant.
T
ctCO2(B)
T T TB TB Vol %, .x c c c ctHb
mL/dL,
mmol/L
pH(st) - .xxx c c c
VCO2/V(dry
T T B B T T % .x c c c
air) fraction .xxx
Oximetry The ABL83X FLEX analyzer corresponds to ABL82X FLEX analyzer, but it can
parameters measure ctBil and FHbF).
T T
6-23
6. Parameters ABL800 FLEX reference manual
Oxygen The ABL83X analyzer corresponds to ABL82X analyzer, but it can measure ctBil T T
parameters and FHbF). Number of characters before "." is variable; number of decimals is
constant.
Symbol Unit Num- ABL ABL 81x/ ABL825/827/ Input Sample
ber of 805 820 83x parameter type
deci- FLEX FLEX FLEX
mals
pO2(T) B B T T mmHg; .x e e c T
T T
torr
kPa .xx
pO2(A) B B mmHg; .x c c c FO2(I)+RQ
T T B B Arterial,
torr
kPa .xx e e e capillary
pO2(A,T)B B T T mmHg; .x c c c FO2(I)+RQ+T Arterial,
T T B B T T
torr capillary
kPa .xx e e e
p 50
T T mmHg; .xx e e e*
torr
kPa .xx
p50(T)
T T T T mmHg; .xx e e c* T
T T
torr
kPa .xx
p50(st)
T T mmHg; .xx e e c*
torr
kPa .xx
pO2(Aa)B B
mmHg; .x c c c FO2(I)+ RQ
T T B B Arterial,
torr
kPa .xx e e e capillary
pO2(Aa,T)
B B T T
mmHg; .x e e c FO2(I)+RQ+T Arterial,
T T B B T T
torr
kPa .xx e e e capillary
pO2(a/A)B B % .x c c c FO2(I)+RQ
T T B B Arterial,
fraction .xxx e e e capillary
pO2(a/A, T)
B B T T % .x c c c FO2(I)+RQ+T Arterial,
T T B B T T
6-24
ABL800 FLEX reference manual 6. Parameters
Oxygen The ABL83x FLEX analyzer corresponds to ABL82x FLEX analyzer, but it can
parameters T measure ctBil and FHbF.
T T
(continued)
Number of characters before "." is variable; number of decimals is constant.
T
FO2(I)
T T B B fraction .xx
pO2(x) B B mmHg; torr .x e e* c* ctHb+p50(st) T T Arterial,
kPa .xx - e* c* capillary
pO2(x,T) B B T T mmHg; torr .x e e* c* ctHb+p50(st)+T T T T T Arterial,
kPa .xx - e* c* capillary
ctO2(B) B B Vol %, .x e e c ctHb
mL/dL,
mmol/L
arterial
mmol/L
BO2 B B Vol %, .x e e c ctHb
mL/dL,
mmol/L
ctO2(x) B B Vol %, .x e e* c* ctHb +p50(st) P P T T P P Arterial,
mL/dL, capillary
mmol/L
mL/min e e c Arterial,
DO2 B B Qt B B
mmol/min .x capillary
L/min .x e e c Venous +
Qt V O2
arterial
B B
B B
mL/min e e c Venous +
V O2 B B
Qt B B
mmol/min .x arterial
FShunt
T T % .x e e c* ctHb Venous
fraction .xxx + arterial
FShunt(T)
T T T T % .x e e c* ctHb + T T T Venous +
fraction .xxx arterial
6-25
6. Parameters ABL800 FLEX reference manual
Oxygen The ABL83x FLEX analyzer corresponds to ABL82x FLEX analyzer, but it can
parameters T measure ctBil and FHbF.
T T
(continued)
Number of characters before "." is variable; number of decimals is constant.
T
VO2/V (dry
T T B B T T % .x c c c
air) fraction .xxx
Qx B B - .x e e* c* ctHb1) P Arterial,
+p50(st) 1)
P T T P P capillary
e e* c*
V(B)
T T L .x c c c ctHb+VCO+ T T
FCOHb(1)+
FCOHb(2)
* If the sO2 value for establishing the ODC is greater than 0.97, the calculation of
B B
the parameter is not performed unless the p50(st) value is keyed in.
T T
1)
P If not measured, e.g. ctHb (or derived by analyzer, e.g. p50(st)).
P T T
Electrolyte Numerical format: number of characters before "." is variable; number of decimals
parameters is constant.
Symbol Unit Num- ABL8x5/8x7 Input Sample
ber of FLEX parameter type
deci-
mals
Anion Gap, K+ P P meq/L, mmol/L .x c2)P P
3)
Anion Gap meq/L, mmol/L .x c P P
mOsm
T T mmol/kg .x c5)P P
6-26
ABL800 FLEX reference manual 6. Parameters
Metabolite Numerical format: number of characters before "." is variable; number of decimals
parameters is constant.
Symbol Unit Num- ABL8x7 Input Sample
ber of FLEX parameter type
deci-
mals
GFR, if AA mol/L c6)
P P Crea, Sex, Arterial
Age
GFR, if non AA mol/L c6)
P P Crea, Sex, Arterial
Age
6) For patients >18 years [24].
6-27
6. Parameters ABL800 FLEX reference manual
List of equations
Units and All definitions and equations are based on SI units. If "T" for patient temperature is
symbols not stated, the calculation is based on a temperature of 37.0 C.
The following SI units are used:
concentration in mmol/L
temperature in C
pressure in kPa
fractions (not %)
ln(x) = loge(x) B B
If ctHb is not measured or keyed in, the default value will be used.
If sO2 is not measured, it will be calculated from equation 39.
B B
pH(T) T T Eq. 1
T [13]:
T T
cH + (T )=10 (
9 pH ( T ) )
pCO2(T)
T T B B Eq. 3
T [4]:
T T
cHCO3(P)
T T B PB P Eq. 4
T [5]:
T T
where
pK p =6.125log 1+10 (pH 8.7 ) [ ]
cHCO3(P) includes ions of hydrogen carbonate, carbonate and carbamate in the
B PB P
plasma.
6-28
ABL800 FLEX reference manual 6. Parameters
cBase(B)
T T Eq. 5
T [4,14]:
T
2
8a'-0.919 0.919 - 8a' 24.47 cHCO -3 (5.33)
cBase(B) = 0.5 + 0.5 4
a' a' a'
where
Eq. Description
5.1 a'= 4.04 10 -3 + 4.25 10 4 ctHb
5.2 ( pH(st) 6.161)
- 0.9524
cHCO 3 (5.33) = 0.23 5.33 10
cBase(B,ox)
T T Eq. 6
T T [4]:
cBase(B,ox) = cBase(B) 0.3062 ctHb (1 sO 2 )
cBase(Ecf)
T T Eq. 7
T T [5]:
cBase(Ecf) = cBase(B) for ctHb = 3 mmol/L
cBase(Ecf,ox)
T T Eq. 8:
T T
cHCO3(P,st)
T T B PB P Eq. 9
T [4,14]:
T
where
Eq. Description
9.1 a'= 4.04 10 -3 + 4.25 10 4 ctHb
9.2 Z = cBase(B)- 0.3062 ctHb (1- sO 2 )
ctCO2(P)
T T B B Eq. 10 [4,5]:
T T
6-29
6. Parameters ABL800 FLEX reference manual
ctCO2(B)
T T B B Eq. 11 [5]:
T T
Eq. Description
11.1 pH Ery = 7.19 + 0.77 ( pH - 7.40) + 0.035 (1 sO 2 )
pO2(T)
T T B B T T Eq. 14 [16,17]:
T T
The standard Oxygen Dissociation Curve (ODC) is used (i.e. p50(st) = 3.578 kPa) at
actual values of pH, pCO2, FCOHb, FMetHb, FHbF (see equations 46-47 in the
B B
where
6-30
ABL800 FLEX reference manual 6. Parameters
TpO2(T) T B B T T
2
14.4
pH
. 10 2 6.5 10 3 ( pH (37) 7.40)
14.8
= 146
(T )
When t i ( T ) = t i (37.0), then pO 2,i ( T ) = pO 2 ( T )
pO2(A)
T T B B Eq. 15 [5]: T T
[
pCO 2 RQ 1 FO 2 (I) RQ 1 1 ( )]
If FO2(I) and RQ are not keyed in, they are set to the default values.
B B
pO2(A,T)
T T B B T T Eq. 16 [4,5,18]:
T T
pH 2 O(T ) = 6.275 10
[ 2.3610 2
( T 37 .0 ) 9 .6 10 5 ( T 37 .0 )
2
]
If FO2(I) and RQ are not keyed in, they are set to the default values.
B B
6-31
6. Parameters ABL800 FLEX reference manual
pO2(a)/FO2(I)
B B T T B B Eq. 17:
T T
pO 2 (a)
pO 2 (a) / FO 2 (I) =
FO 2 (I)
The calculation cannot be performed on the basis of the default FO2(I) value, and
T T B B
pO2(a,T)/FO2(I)
B B T T T T B B Eq. 18:
T T
pO 2 (a , T )
pO 2 (a, T ) / FO 2 (I) =
FO 2 (I)
The calculation cannot be performed on the basis of the default FO2(I) value, and
T T B B
p50
T T Eq. 19 Refer to Eq. 46.10:
T T
P
p50 =
FCOHb
1+
0.5 (1- FCOHb - FMetHb )
where
Description See...
P = ODC(S,A,T) T T Eq. 47
0.5 (1 FCOHb - FMetHb) + FCOHb Eq. 46.11
S=
1- FMetHb
A=a
T = 37.0 oC
T T P P Eq. 46.13
p50(T)
T T T T Eq. 20:
The ODC is determined as described in equations 46-47 in the section
Oxyhemoglobin Dissociation Curve further in this chapter.
T T
P
p50(T )=
FCOHb
1+
0.5 (1- FCOHb - FMetHb )
where
6-32
ABL800 FLEX reference manual 6. Parameters
p50(T)
T T T T T
Description See
(continued) T
P = ODC(S,A,T) T T Eq. 47
0.5 (1 FCOHb - FMetHb) + FCOHb Eq. 46.11
S=
1- FMetHb
pH
A=a 1.04 (T 37.0)
(T )
pH
. 10 2 6.5 10 3 ( pH (37) 7.40)
= 146
(T )
T = patient temperature in oC (keyed-in)
T T P P
p50(st)
T T Eq. 21:
T T
p50 is calculated for pH = 7.40, pCO2 = 5.33 kPa, FCOHb = 0, FMetHb = 0, FHbF
B B
= 0.
The ODC is determined as described in equations 46-47 in the section
Oxyhemoglobin Dissociation Curve, see equation 47 further in this chapter.
T T
p50(st) = ODC(S,A,T) T T
where
Description See
S = 0.5 Eq. 46.11
A = a6 corresponds to pH = 7.40, pCO2 = 5.33 kPa, FCOHb = 0, B B Eq. 46.13
FMetHb = 0, FHbF = 0
T = 37.0 oC
T T P P
pO2(A-a)
T T B B Eq. 22:
T T T
pO 2 (A a) = pO 2 (A) - pO 2 (a)
The calculation requires entering the sample type as Arterial or Capillary.
pO2(A-a,T)
T T B B T T Eq. 23:
T T T
pO 2 (A a, T ) = pO 2 (A, T ) pO 2 (a, T )
The calculation requires entering the sample type as Arterial or Capillary.
6-33
6. Parameters ABL800 FLEX reference manual
pO2(a/A)
T T B B Eq. 24:
T T T
pO 2 (a)
pO 2 (a/A) =
pO 2 ( A )
The calculation requires entering the sample type as Arterial or Capillary.
pO2(a/A,T)
T T B B T T Eq. 25:
T T T
pO 2 (a, T )
pO 2 (a/A, T ) =
pO 2 (A, T )
The calculation requires entering the sample type as Arterial or Capillary.
pO2(x)
B B Eq. 26 [8]:
T T T
(or px) T TB B The ODC is determined as described in equations 46-47 in the section
Oxyhemoglobin Dissociation Curve further in this chapter.
T T
26.5 A=a
26.6 T = 37 oC
T T P P
When ti = ctO2 2.3 mmol/L, then pO2,i = pO2(x), where ctO2 is determined as
B B B B B B B B B B
pO2(x) can only be calculated if the measured sO2(a) 0.97 (or p50(st) keyed in).
B B B B
6-34
ABL800 FLEX reference manual 6. Parameters
ctO2
T T B B Eq. 27 [5]:
T T
ctO2(av )
T T B B
Eq. 28:
ctO2(a v ) = ctO2(a) ctO2(v )
B B B B B B
where ctO (a) and ctO (v ) are calculated from equation 27 for arterial and mixed
2
B B
2
B B
BO2
T T B B Eq. 29 [7]:
T T T
ctO2(x)
T T B B Eq. 30 [8]:
T T
(or cx)
The ODC is determined, as described in equations 46-47 in the section
T TB B
ctO 2 ( x) = ctO 2 ( a) t i
where
6-35
6. Parameters ABL800 FLEX reference manual
ctO2(x)
T T B B ctO2(a) is determined as described in equation 27.
B B
(or cx)
ctO2(x) cannot be calculated on the basis of a default ctHb value.
B B T
(continued)
B B
ctO2(x) can only be calculated if the measured sO2(a) 0.97 (or if p50(st) is keyed
B B B B
in).
The calculation requires entering the sample type as Arterial or Capillary.
Eq. 31:
D O2
. .
B B
D O 2 = ctO 2 Q t
Q t is the cardiac output and is an input parameter for calculation of DO2.
B B B B
If Q t is not keyed in, DO2 will not be calculated.
B B B B
Eq. 32:
Qt
.
B B
. V O2
Qt =
ctO 2 ( a v)
If V O2 is not keyed in, Q t will not be calculated.
B B B B
Eq. 33:
VO2
. .
B B
V O 2 = Q t ctO 2 (a v)
If Q t is not keyed in, VO2 will not be calculated.
B B B B
ctO 2 ( c) ctO 2 (a )
FShunt =
ctO 2 (c) ctO 2 ( v)
and
Eq. Description
34.1 ctO 2 (A ) ctO 2 ( a )
FShunt
ctO 2 ( A ) ctO 2 ( v)
6-36
ABL800 FLEX reference manual 6. Parameters
FShunt
T T
Eq. Description
(continued)
T T
1
34.2 ctO 2 (a ) ctO 2 ( v )
FShunt = 1 +
ctO 2 (A ) ctO 2 (a )
where
ctO2(c): total oxygen in pulmonary capillary blood
B B
entered
sO2(a): oxygen saturation in arterial blood; can be measured
B B
determine the ODC. If sO2(a) > 0.97 and no p50(st) has been keyed in, the
B B
If sO2(a) > 0.97, a keyed-in p50(st) will be used to determine the ODC.
B B
6-37
6. Parameters ABL800 FLEX reference manual
FShunt(T)
T T T T Eq. 35 [5,16]:
T T
1
ctO 2 (a, T ) - ctO 2 (v, T )
FShunt(T ) = 1 +
ctO 2 (A, T ) - ctO 2 (a, T )
where
ctO2(a,T): total oxygen in arterial blood at patient temperature
B B T T
ctO2(A,T): total oxygen in alveolar blood at patient temperature ctO2(v ,T): total
B B T T B B T T
O2 (T ) = 9.83 10 3 e [ ]
35.3 -1.1510 -2 ( T -37.0 ) + 2 .110 4 (T 37 .0 )
2
35.5 sO2(A,T) = SB B T T
35.8 pH
A = a 104
. (T 37.0)
(T )
35.9 T = patient temperature (keyed-in)
T T
35.10 pH
. 10 2 6.5 10 3 ( pH (37) 7.40)
= 146
(T )
If sO2(a) > 0.97, a keyed-in p50(st) will be used to determine the
B B
ODC. If sO2(a) > 0.97 and no p50(st) has been keyed in, the B B
mixed venous blood values of pO2 and sO2. If sO2(v ) > 0.97, a B B B B B B
If sO2(v )>0.97 and no p50(st) has been keyed in, the default
B B
6-38
ABL800 FLEX reference manual 6. Parameters
RI Eq. 36:
T T T
pO 2 (A ) pO 2 ( a)
RI =
pO 2 (a )
The calculation requires entering the sample type as Arterial or Capillary.
pO 2 (A , T ) pO 2 (a, T )
RI(T ) =
pO 2 (a , T )
The calculation requires entering the sample type as Arterial or Capillary.
Qx
B B Eq. 38 [8]:
T T
2.3
Qx =
ctO 2 (a ) t i
38.3 S = ODC(P,A,T) T T
6-39
6. Parameters ABL800 FLEX reference manual
sO2
T T B B Eq. 39:
T T T
The ODC is determined as described in equation 46 (points I and III). See the section
Oxyhemoglobin Dissociation Curve further in this chapter.
T T
S (1 FMetHb) FCOHb
sO 2 =
1 - FCOHb - FMetHb
where
Description See
S = ODC(P,A,T) T T
FO2Hb
T T B B Eq. 40:
FO 2 Hb = sO 2 (1 FCOHb FMetHb)
If sO2 is not measured, it will be calculated from equation 39.
T T B B
If dyshemoglobins (FCOHb, FMetHb) are not known, they are set to the default
values.
FHHb
T T Eq. 41:
FHHb = 1 sO 2 (1 FCOHb FMetHb) FCOHb FMetHb
If sO2 is not measured, it will be calculated from equation 39.
T T B B
If dyshemoglobins (FCOHb, FMetHb) are not known, they are set to the default
values.
V(B)
T T Eq. 42 [5]: T T
1 10 3 V (CO)
V ( B) =
24 ( FCOHb(2) FCOHb(1) ) 0.91 ctHb
6-40
ABL800 FLEX reference manual 6. Parameters
V(B)
T T Eq. Description
(continued)
42.1 V (CO)
T T
V ( B) =
2.184 10 ( FCOHb(2) FCOHb(1) ) ctHb
-2
42.2 V(CO) = volume (in mL) of carbon monoxide injected according to the
procedure and the value keyed in
42.3 FCOHb(1) = fraction of COHb measured before the CO injection
42.4 FCOHb(2) = fraction of COHb measured after the CO injection
cCa2+(7.4)
T T P P Eq. 45 Ref. [12]:
[
cCa 2 + (7.4) = cCa 2 + 1 0.53 (7.40 pH ) ]
Due to biological variations this equation can only be used for a pH value in the
range 7.2-7.6.
Eq. 46-47 See Oxyhemoglobin dissociation curve (ODC), page 6-44 in this chapter.
T T T T
mOsm
T T Eq. 48:
T
An iterative method is used to calculate FHbF. The input parameters are sO2, ceHb B B T T
moglobin).
In the calculations the following are assumed: pH = 7.4, pCO2 = 5.33 kPa, FCOHb B B
6-41
6. Parameters ABL800 FLEX reference manual
FHbF
T T T
5. cO 2 HbFmeas. cO 2 HbFest
FHbFest =
ceHb
6. If |FHbFest| 0.001, proceed to step 7.
T T B B T T
8. Return to step 2. T T
50.5 A=a
50.6 T = patient temperature
T T
6-42
ABL800 FLEX reference manual 6. Parameters
pO2(x,T)
T T B B T T
Eq. Description
(continued)
T
pO2(x,T) can only be calculated if the measured sO2(a) 0.97 (or p50(st) keyed in).
B B T T B B
pO2(x,T) is tagged with "?" if any of the following parameters: sO2, FMetHb,
B B T T B B
pCO 2
VCO 2 / V (dry air) =
p(amb) 6.275
VO2/V(dry air)
T T B B T T Eq. 52:
T T T
pO 2
VO 2 / V (dry air) =
p(amb) 6.275
1.210
T
6-43
6. Parameters ABL800 FLEX reference manual
ODC equations These equations account for the effect of FCOHb on the shape of the
Oxyhemoglobin Dissociation Curve (ODC) in accordance with the Haldane
equation.
Eq. 46 [16,18]:
T T T
[ (
y y o = ( x x o ) + h tanh k o x x o )]
where ko = 0.5343
P P
Eq. Description
46.1 x = ln p
46.2 s
y = ln
1- s
46.3 so
y o = ln where so = 0.867
1 - so
T TP P
The actual position of the ODC in the coordinate system (ln(s/(1s)) vs ln(p)) used in
the mathematical model, is expressed by equations 46.3 and 46.4.
The symbols "a" and "b" reflect the ODC displacement from the reference position
to its actual position in this coordinate system:
"a" describes the displacement at 37 C.
"b" the additional displacement due to the patient temperature difference from 37 C.
The ODC The reference position of the ODC was chosen to be the one that corresponds to the
reference default value for p50(st) = 3.578 kPa, which is traditionally considered the most
position likely value of p50 for adult humans under standard conditions, namely:
pH = 7.40
pCO2 = 5.33 kPa
B B
6-44
ABL800 FLEX reference manual 6. Parameters
The ODC The ODC displacement which is described by "a" and "b" in the coordinate system
displacement (ln(s/(1s))vsln(p)), is given by the change in p50 from the default to its actual value
in a more common coordinate system (sO2, pO2). B B B B
Eq. Description
46.5 p
x x o = ln ab
7
46.6 h = ho + a where ho = 3.5P P
46.7 b = 0.055 (T T o ) To = 37 oC
T TP P P P
46.8 p = pO 2 + M pCO
where M pCO is taken from the Haldane equation [20]:
pO 2 pCO
=M , to give eq. 46.9
cO 2 Hb cCOHb
46.9 pO 2 FCOHb
p = pO 2 + or equation 46.10
sO 2 1 - FCOHb - FMetHb
46.10
pO 2 =
[
p sO 2 (1 FCOHb FMetHb) ]
1 + FCOHb
Eq. Description
46.11 cO 2 Hb + cCOHb
s=
cO 2 Hb + cCOHb + cHHb
or
sO 2 (1 - FCOHb - FMetHb) + FCOHb
=
1 FMetHb
46.12 s (1 - FMetHb) FCOHb
sO 2 =
1 FCOHb FMetHb
6-45
6. Parameters ABL800 FLEX reference manual
The actual ODC The actual position of the ODC at 37 C for a given sample is, in principle,
position determined in two steps:
1. The calculation of the combined effect on the ODC position at 37 C of all
known causes for displacement (= ac in equation 46.13), and based on this
position.
2. The computation by a numerical method of the actual position of the ODC curve
by shifting it to pass through the known set of coordinates (P0, S0). B B B B
Eq. Description
46.13 a = ac + a6
46.14 ac = a1 + a2 + a3 + a4 + a5
46.15 a1 = 0.88 (pH 7.40)
46.16 pCO 2
a2 = 0.048 ln
5.33
46.17 a3 = 0.7 FMetHb
46.18 a4 = (0.06 0.02 FHbF) (cDPG 5)
Determining the
actual Step Description
displacement I: pO2, sO2 can be used.
B B B B
below. T
and (46.11).
If FCOHb and FMetHb are not known, the default values
are used.
The ODC is shifted from the reference position to a
position that corresponds to the effect of all measured
parameters according to step I.
The magnitude of the shift is ac.
The ODC is then further shifted to pass through the point
(P0, S0).
B B B B
6-46
ABL800 FLEX reference manual 6. Parameters
Determining the
actual Step Description
displacement T
II: sO2 > 0.97 (or erroneous) and p50(st) is keyed in.
B B
(continued)
Coordinates (P0, S0) are calculated from (p50(st), 0.5) using
T
B B B B
(III): sO2 > 0.97 (or erroneous) and no p50(st) has been keyed in.
B B
"ac".
NOTE:
T T The curves are used only to illustrate the principles of the ODC determination
6-47
6. Parameters ABL800 FLEX reference manual
S = ODC(P, A, T) or T T P = ODC(S, A, T)
T T
To calculate S or P and to further calculate sO2 and pO2, the other variables should
B B B B
6-48
ABL800 FLEX reference manual 6. Parameters
Conversion of units
SI units The equations stated above are based on the SI-unit system. If parameters are known
in other units, they must be converted into a SI unit before entering the equations.
The result will be in an SI unit.
After the calculation the result may be converted to the desired unit. Conversion of
units may be performed, using the equations stated below:
Temperature 9
T F = (T o C ) + 32
5
T T
5
T C = (T oF 32)
9
T T
cCa2+ P P
cCa2+ (meq/L)
T T P P
2+
= 2 cCa (mmol/L) or
T T P P
2+
cCa2+ (mg/dL)
T T P P = 4.008 cCa (mmol/L) T T P P
2+
cCa2+ (mmol/L)
T T P P = 0.5 cCa (meq/L)or
T T P P
2+
cCa2+ (mmol/L)
T T P P = 0.2495 cCa (mg/dL) T T P P
ctHb [4]
ctHb (g/dL)
T T = 1.61140 ctHb (mmol/L)
ctHb (g/L) = 16.1140 ctHb (mmol/L) or
ctHb (mmol/L) = 0.62058 ctHb (g/dL)
ctHb (mmol/L) = 0.062058 ctHb (g/L)
ctCO2, ctO2,
T T B B B B
Vol %
6-49
6. Parameters ABL800 FLEX reference manual
VO2 B B VO2 (mmol/L)/min = VO2/22.41 (mL/dL)/min
B B B B
T cGlucose
T
[22]
cLactate
T T
[22]
ctBil
T T
ctBil (mol/L)
T T
= 17.1 ctBil (mg/dL)
ctBil (mol/L) = 1.71 ctBil (mg/L) or
ctBil (mg/dL) = 0.0585 ctBil (mol/L)
ctBil (mg/L) = 0.585 ctBil (mol/L)
cCrea
T T
cCrea (mol/L) = 88.40 cCrea (mg/dL)
T T
NOTE:
T T All conversions of units are made by the analyzer.
6-50
ABL800 FLEX reference manual 6. Parameters
Default values
Values The following default values are used in the ABL800 FLEX analyzers, if other
values are not keyed in.
T
T T = 37.0 C (99 F)
FO2(I)
B B = 0.21 (21.0 %)
RQ = 0.86
ctHb = 9.3087 mmol/L, (15.00 g/dL or 150 g/L)
FCOHb = 0.004 (0.4 %)
FMetHb = 0.004 (0.4 %)
p50(st) = 3.578 kPa (26.84 mmHg)
In addition to the above default values, the ABL8x7 FLEX analyzers use the
following default:
Ambient temperature = 25.0 C (77 F).
6-51
6. Parameters ABL800 FLEX reference manual
Altitude correction
Equation for The barometric pressure is measured by the analyzer's built-in barometer, and the
altitude effect of barometric pressure on blood samples is compensated by the analyzers
correction software.
Quality control result for pO2 obtained on aqueous quality control solutions at low
B B
sea level can be expressed by an altitude correction that can be added to the control
ranges.
The relationship between the altitude and barometric pressure can be expressed by
the following equation:
Bref Bact
A = 16000 (1 + 0.004T )
Bref + Bact
where:
A
T T = altitude in m
T
T T
= temperature in C
Bref
T B TB = standard barometric pressure at sea level = 760 mmHg
Bact
T B TB = actual barometric pressure in mmHg.
Reference [23].
6-52
ABL800 FLEX reference manual 6. Parameters
References
List of 1. The Deep PictureTM, critical information from blood gas analysis. Copenhagen:
P P
6-53
6. Parameters ABL800 FLEX reference manual
References, Continued
T T
List of 15. Kokholm G. Simultaneous measurements of blood pH, pCO2, pO2 and
B B B B
in blood. Scand J Clin Lab Invest 1988; 48, Suppl 189: 85-88.
18. Siggaard-Andersen O, Siggaard-Andersen M. The oxygen status algorithm: a
computer program for calculating and displaying pH and blood gas data. Scand J
Clin Lab Invest 1990; 50, Suppl 203: 29-45.
19. Bartels H, Christoforides C, Hedley-Whyte J, Laasberg L. Solubility coefficients
of gases. In: Altman PL, Dittmer DS, eds. Respiration and circulation. Bethesda,
Maryland: Fed Amer Soc Exper Biol, 1971: 16-18.
20. Roughton FJW, Darling RC. The effect of carbon monoxide on the
oxyhemoglobin dissociation curve. Am J Physiol 1944; 141: 17-31.
21. Engquist A.. Fluids electrolytes nutrition. Copenhagen: Munksgaard, 1985: 56-
68 and 118.
22. Olesen H et al. A proposal for an IUPAC/IFCC recommendation, quantities and
units in clinical laboratory sciences. IUPAC/IFCC Stage 1, Draft 1, 1990: 1-
361.
23. Kokholm G, Larsen E, Jensen ST, ChristiansenTF. 3rd ed. Blood gas
measurements at high altitudes. Copenhagen: Radiometer Medical A/S, 1991.
Available as AS109.
24. U.S Department of Health and Human Services, National Institutes of Health,
National Institute of Diabetes and Digestive and Kidney Diseases: NKDEP
National Kidney Disease Education Program. Rationale for Use and Reporting of
Estimated GFR. NIH Publication No. 04-5509. Revised November 2005.
25. Myers GL, Miller WG, Coresh J, Fleming J, Greenberg N, Greene T, Hostetter
T, Levey AS, Panteghini M, Welch M, and Eckfeldt JH for the National Kidney
Disease Education Program Laboratory Working Group. Clin Chem, 52:5-18,
2006; First published December 6, 2005, 10.1373/clinchem.2005.0525144.
6-54
7. Solutions and gas mixtures
Overview
Introduction This chapter gives information about all the solutions and gases used with the
ABL800 FLEX analyzer, their composition, use and consumption.
The Certificates of Traceability for the calibrating solutions are found at the end of
the chapter.
7-1
7. Solutions and gas mixtures ABL800 FLEX reference manual
General information
In Vitro All the solutions described in this chapter are for in vitro diagnostic use.
T T
Diagnostic Use
Solution Each solution is identified with an "S" and is followed by 4 or 5 digits. The name
numbers of the solution comes after the number.
Gas names The two gas mixtures used by the analyzer are named Gas 1 and Gas 2.
Expiration date The expiration date of a solution found on the label or on a sticker on the side of
the container is stated as a year and month. Do not use a product after its expiration
date.
Safety Data Safety Data Sheets for all solutions are available from your Radiometer distributor.
Sheets
Reordering Information for reordering solutions from Radiometer can be found in the ABL800T
7-2
ABL800 FLEX reference manual 7. Solutions and gas mixtures
Calibration solutions
S1820 and Use: For calibration of the pH, electrolyte and metabolite
S1830 electrodes in the ABL835/30/25/20/15/10/05 FLEX
analyzers.
Quantity: 200 mL
Composition: Contains the following substances with the stated nominal
concentrations:
Solution Substance Concentration (mmol/L)
S1820 K+ P 4
+
Na P 145
Ca2+ P 1.25
Cl P
102
cGlu
T T
10
cLac 4
buffer Maintains a pH of 7.40
+
S1830 K P 40
+
Na P 20
Ca2+ P 5
Cl P
50
buffer Maintains a pH of 6.9
The exact values are included in the ba code.
T T
7-3
7. Solutions and gas mixtures ABL800 FLEX reference manual
7-4
ABL800 FLEX reference manual 7. Solutions and gas mixtures
S7770 tHb Use: For calibration of the cuvette optical path length.
Calibration The calibrated value can be ctHb, ctHb and ctBil, or ctBil
T T T T
7-5
7. Solutions and gas mixtures ABL800 FLEX reference manual
S4980 Rinse Use: For rinsing the liquid transport system after each measurement
Solution or calibration in the ABL835/30/25/20/15/10/05 FLEX
analyzers.
Quantity: 600 mL
Composition: Contains salts, buffer, anticoagulant, preservatives, and
surfactants.
Storage: At 2-32 oC (36-90 oF).
P P P P
Stability: Expiration date and Lot no. are printed on a separate label.
When stored between 2-32 oC (36-90 oF), S4980 is stable for 25
P P P P
S4987 Rinse Use: For rinsing the liquid transport system after each measurement
Solution or calibration in the ABL837/27/17 FLEX analyzers.
Quantity: 600 mL
Composition: Contains salts, buffer, anticoagulants, preservatives and
surfactants.
Storage: At 2-32 oC (36-90 oF).
P P P P
Stability: Expiration date and Lot no. are printed on a separate label.
When stored between 2-32 oC (36-90 oF), S4987 is stable for 25
P P P P
S8370 Cleaning
Use: For cleaning the liquid transport system automatically or called
Solution
by operator in the ABL835/30/25/20/15/10/05 FLEX analyzers.
Quantity: 200 mL
Composition: Contains salts, buffer, anticoagulant, preservatives and
surfactants.
Storage: At 2-32 oC (36-90 oF).
P P P P
Stability Expiration date and Lot no. are printed on a separate label.
S5370 Cleaning
Use: For adding to the S8370 Cleaning solution.
Additive
Composition: Contains powdered streptokinase.
Storage: At 2-10 C (36-50 F).
Stability: Expiration date and Lot no. are printed on a separate label.
The Cleaning Solution with the Cleaning Additive is stable for 2
months in use.
7-6
ABL800 FLEX reference manual 7. Solutions and gas mixtures
S5370 Cleaning May cause sensitization by inhalation and skin contact. Do not
WARNING/ T
Additive
T
CAUTION: breathe dust. Avoid contact with skin.. Wear suitable gloves. In
(continued)
T
T
case of accident or if you feel unwell, seek medical advice
immediately (show the label where possible). T
S8377 Cleaning Use: For cleaning the measuring system of the ABL837/27/17 FLEX
Met II Solution analyzers and for checking high creatinine level.
Quantity: 100 mL
Composition: Contains: cCrea = 1500 mol/L, salts, buffer, anticoagulants,
T T
Stability Expiration date and Lot no. are printed on a separate label.
The Cleaning Met II Solution is stable for 14 days in use.
WARNING/ Contains streptokinase. May cause allergic reaction.
CAUTION
7-7
7. Solutions and gas mixtures ABL800 FLEX reference manual
Electrolyte solutions
List of solutions The following electrolyte solutions contained in the electrode jackets of the
Radiometer electrodes are used:
contact with eyes, rinse immediately with plenty of water and seek medical advice. T
7-8
ABL800 FLEX reference manual 7. Solutions and gas mixtures
Storage
Temperature:
T T Electrolyte solution:
T T
Stability Expiration date and Lot No. are printed on a label on the side of the membrane
box.
7-9
7. Solutions and gas mixtures ABL800 FLEX reference manual
S5362
Use: For protein removal and decontamination according to the
Hypochlorite
procedures described in the Operator's Manual, chapter 4:
Solution
T T
7-10
ABL800 FLEX reference manual 7. Solutions and gas mixtures
Cylinder types The following types of Gas 1 cylinders are used depending on the geographical
location of the analyzer:
T T
Gas 1 T Gas 2 T
EU USA Japan
Cylinder volume 1L 1L 1L 1L
Gas volume 10 L 33 L 25 L 10 L
Fill pressure 140 psi 500 psi 375 psi 140 psi
at 25 oC
P P (10 bar) (34 bar) (26 bar) (10 bar)
Composition 19.76 % O2, 5.60 % CO2
B B B B
< 0.04 % O2, 11.22 % CO2
B B B B
74.64 % N2 B B
88.78 % N2 B B
WARNING/ Pressurized container. Non-flammable compressed gas. Do not breathe gas. Gas
T
CAUTION: mixtures containing less than 19.5 % oxygen may cause suffocation. Protect from
sunlight and do not expose to temperatures exceeding 50 oC (122 oF). Store and P P P P
use with adequate ventilation. Keep away from oil and grease. Do not refill. T
NOTE:
T T The exact composition of each gas mixture is given in the barcode on the gas
T
Stability Gas 1 and Gas 2 are stable for 25 months from the date of filling.
Storage The gas cylinders should be stored between 2-32 oC (36-90 oF). P P P P
7-11
7. Solutions and gas mixtures ABL800 FLEX reference manual
Traceability certificates
7-12
ABL800 FLEX reference manual 7. Solutions and gas mixtures
7-13
7. Solutions and gas mixtures ABL800 FLEX reference manual
7-14
ABL800 FLEX reference manual 7. Solutions and gas mixtures
7-15
7. Solutions and gas mixtures ABL800 FLEX reference manual
7-16
ABL800 FLEX reference manual 7. Solutions and gas mixtures
7-17
7. Solutions and gas mixtures ABL800 FLEX reference manual
7-18
ABL800 FLEX Reference Manual Index
Index
A
ABL837/27/17 performance characteristics .................................................................... 5-72
Absorbance ........................................................................................................................ 3-4
Additional information about FLEXMODE .................................................................... 5-48
Altitude Correction .......................................................................................................... 6-52
Amperometric method ....................................................................................................... 2-2
B
Bias .................................................................................................................................... 5-2
BiasABL chart description ................................................................................................... 5-7
B B
C
Calibration ..................................................................................................................1-3, 2-3
Calibration line .................................................................................................................. 1-4
Calibration materials...................................................................................................1-7, 2-3
Calibration Solutions ......................................................................................................... 7-3
Continuous spectrum ......................................................................................................... 3-5
Contribution to imprecision specifications from HbF correction .................................... 5-96
Conversion of Units ......................................................................................................... 6-49
Correcting for Interferences............................................................................................... 3-7
Correction Factors for Oximetry Parameters and Bilirubin ............................................... 4-4
Corrrection Factors for Electrolyte and Metabolite Parameters......................................... 4-7
Crea electrodes................................................................................................................. 2-23
Calibration material ..................................................................................................... 2-25
Description .................................................................................................................. 2-23
Drift ............................................................................................................................. 2-28
Measurements and corrections .................................................................................... 2-29
Sensitivity.................................................................................................................... 2-26
Sensitivity limits.......................................................................................................... 2-28
Zero current ................................................................................................................. 2-25
ctBil sensitivity for pH changes ....................................................................................... 5-99
T T
D
Default Values ................................................................................................................. 6-51
Defintion of terms.............................................................................................................. 5-2
Derived Parameters.......................................................................................................... 6-17
Determining concentrations ............................................................................................... 3-6
Drift ................................................................................................................................... 1-6
E
Electrolyte electrodes
Calibration solution values .......................................................................................... 1-26
Corrections .................................................................................................................. 1-30
Drift ............................................................................................................................. 1-28
Sensitivity.................................................................................................................... 1-27
Stability criteria ........................................................................................................... 1-35
Status ........................................................................................................................... 1-28
Electrolyte Electrodes ...................................................................................................... 1-23
Electrolyte Solutions.......................................................................................................... 7-8
F
FHbF sensitivity for pH changes ..................................................................................... 5-97
T T
Index ABL800 FLEX Reference Manual
G
Gas Mixtures (Gas 1 and Gas 2) ...................................................................................... 7-11
Glucose and lactate electrodes ......................................................................................... 2-13
Corrections .................................................................................................................. 2-18
Drift ............................................................................................................................. 2-17
Sensitivity.................................................................................................................... 2-16
Stability criteria ........................................................................................................... 2-21
Zero current ................................................................................................................. 2-14
H
HbF versus HbA ................................................................................................................ 3-7
Hypochlorite Solution...................................................................................................... 7-10
I
Imprecision ........................................................................................................................ 5-3
Imprecision chart ............................................................................................................... 5-8
Input Parameters .............................................................................................................. 6-14
Interference tests
cCrea............................................................................................................................ 5-99
T T
Electrolytes.................................................................................................................. 5-92
Metabolites .................................................................................................................. 5-93
Oximetry parameters ................................................................................................... 5-95
pH/blood gas................................................................................................................ 5-92
L
Lambert-Beers law ........................................................................................................... 3-4
List of Equations.............................................................................................................. 6-28
M
Matrix of constants ............................................................................................................ 3-6
Mean Corpuscular Hemoglobin Concentration
MCHC ......................................................................................................................... 5-97
Measured parameters ..................................................................................................3-2 ,6-5
Measuring time .................................................................................................................. 1-7
N
Nernst equation .........................................................................................................1-2, 1-25
O
Optical System................................................................................................................... 3-2
Oximetry and bilirubin
Measurement and Corrections ....................................................................................... 3-9
Oxyhemoglobin Dissociation Curve (ODC).................................................................... 6-44
P
Parameters
Ranges and limits .......................................................................................................... 6-3
Symbols ......................................................................................................................... 6-2
pCO2 electrode
T T B B
pH electrode
Corrections .................................................................................................................. 1-11
Drift ............................................................................................................................. 1-10
Sensitivity.................................................................................................................... 1-10
Stability criteria ........................................................................................................... 1-14
Status ........................................................................................................................... 1-10
pH Electrode ...................................................................................................................... 1-9
pO2 electrode
T T B B
Date of issue
Publication: 200801
Edition: F
Code number: 989-963
Date of issue ABL800 FLEX Reference manual