ABX Pentra Lactic Acid

ABX Pentra
Ref.: A11A01721
Volume R1: 103 ml
Lactic Acid
Volume R2: 10 x 10 ml

Intended use 2007/06/27

A93A00222E US
Diagnostic reagent for quantitative in-vitro
determination of Lactic Acid in plasma by
A11A01721
colorimetry.
103 ml

Clinical Interest (1) 10 x 10 ml

Lactic acid is the final product of anaerobic glycosis and represents the
main source of energy in certain tissues. It is considered to be the best
marker of the state of oxygenation in tissues.
It is mainly used for resuscitation in the treatment of states of shock
be it hypovolemic, toxi-infectious or cardiogenic as well as for treating
neonatal respiratory acidoses.
This determination is also used in athletic medicine to improve HORIBA ABX
athletic performance. BP 7290
34184 Montpellier- cedex 4 - France

Method (2,3,4)
Enzymatic colorimetric method. Trinder method.
Lactate is an intermediary metabolite of glycolysis involved in Handling
maintaining the blood's pH value. Lactate oxidase triggers the release 1. Dissolve reagent 2 in 10 ml of reagent 1 as shown on the vial of
of hydrogen peroxide, which reacts with 4-aminoantipyrine and ESPAS reagent 2.
to a coloured complex in the presence of peroxidase. The intensity of 2. Wait approx. 15 minutes before use.
the colouring is proportional to the amount of lactate present in the 3. Pour the necessary reagent volume into an appropriate 10 or 15ml
sample. container. Place it on the rack in the ABX Pentra 400 reagent
Lactate oxidase
compartment.
Lactate + O2 Pyruvate + H2O2
Calibrator
Peroxidase
For calibration, use:
2H2O2 + 4AAP + ESPAS Quinoneimine + 4H2O ABX Pentra MultiCal, Ref. A11A01652 (not included)
10 x 3 ml (lyophilisate)
(4 AAP = 4-aminoantipyrine, ESPAS = N-ethyl-N-sulfopropyl-m-anisidine)
Control
Reagents For internal quality control, use:
ABX Pentra Lactic Acid is lyophilized. ABX Pentra N Control, Ref. A11A01653 (not included)
Reagent 1: Phosphate buffer, pH 7.50 100 mmol/l 10 x 5 ml (lyophilisate)
ESPAS 1 mmol/l ABX Pentra P Control, Ref. A11A01654 (not included)
10 x 5 ml (lyophilisate)
Sodium azide 0.05 %
Sodium hydroxide 0.0009 %
Each control should be assayed daily and/or after each calibration.
Reagent 2: Lactate oxidase ≥ 450 U/l The frequency of controls and the confidence intervals should
Peroxidase ≥ 2,000 U/l correspond to laboratory guidelines and country-specific directives.
4-aminoantipyrine 0.40 mmol/l The results must be within the range of the defined confidence limits.
Bovine albumin 0.3 % Each laboratory should establish a procedure to follow if the results
exceed these confidence limits.
ABX Pentra Lactic Acid should be used according to this reagent
notice. HORIBA ABX cannot guarantee its performance if used
otherwise.
Materials required but not provided
• Automated clinical chemistry analyser.
• Standard laboratory equipment.
Form-0846 Rev. 2

S.A.S. au capital de 41.700.000 € - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
 ABX Pentra
Lactic Acid

Specimen (5) Detection limit:

• Plasma in lithium heparin. The detection limit is determined according to the Valtec protocol (7)
and equals 0.3 mg/dl.
Stability:
3 days at 4 - 8 °C Accuracy and Precision:
3 days at 20 - 25 °C • Repeatability (within-run precision)
3 days at -20 °C 3 specimens of low, medium and high concentration and 2 controls are
tested 20 times according to the recommendations found in the Valtec
Reference range (6) protocol (7).
Each laboratory should establish its own reference ranges. The values Mean value mg/dl CV %
given here are used as guidelines only. Normal control 14.6 0.60
Pathological control 29.2 0.70
4.5 - 20 mg/dl
Specimen 1 9.5 0.80
Specimen 2 31.2 0.40
Storage and Stability
Specimen 3 68.1 0.50
Reagents, in unopened vials, are stable up to the expiry date on the
label if stored at 2-8° C.
• Reproducibility (total precision)
Stability on-board: refer to the paragraph ’’Performance on ABX Pentra
2 specimens of low and high levels and 2 controls are tested in
400’’.
duplicate for 20 days (2 series per day) according to the
recommendations found in the CLSI (NCCLS), EP5-A protocol (8).
Stability of ABX Pentra Lactic Acid after reconstitution:
Mean value mg/dl CV %
8 hours at 20-25° C
Normal control 15.1 1.16
7 days at 2-8° C
Pathological control 29.8 1.16
Specimen 1 31.4 1.29
Assay Procedure
Test instructions for automated systems other than ABX Pentra 400 are Specimen 2 66.8 1.65
available on request (not available in the USA). Linearity and Measuring Range:
The reagent linearity is determined according to the recommendations
Waste Management found in the CLSI (NCCLS), EP6-A protocol (9).
1. Please refer to local legal requirements. Low linearity: 0.3 mg/dl
2. This reagent contains less than 0.1 % of sodium azide High linearity: 120 mg/dl, with automatic post-dilution: 360 mg/dl.
(preservative). As sodium azide may react with lead and copper to
form explosive metal azides, this reagent should be disposed of by Correlation:
flushing with copious amounts of water. 100 patient samples are correlated with a commercial reagent taken as
reference according to the recommendations found in the CLSI
General Precautions (NCCLS), EP9-A2 protocol (10).
1. Reagent, for professional in-vitro diagnostic use only. The equation for the allometric line obtained is:
2. The reagent vials should be discarded after use. Y = 1.04 x + 0.36 with a correlation coefficient r = 0.9986.
3. Take the necessary precautions for the use of laboratory reagents.
Interferences:
4. Please refer to the MSDS associated with the reagent.
Haemoglobin: No significant influence is observed up to 500 mg/dl
Performance on ABX Pentra 400 Triglycerides: No significant influence is observed up to 612.5 mg/dl
The performance data listed below have been obtained on the ABX (as Intralipid®, representative of lipemia)
Pentra 400 analyser. Total Bilirubin: No significant influence is observed up to 36 mg/dl
Direct Bilirubin: No significant influence is observed up to 36 mg/dl
Number of tests: 260 tests.
Calibration stability:
On-board Reagent Stability: 7 days The reagent is calibrated on Day 0. The calibration stability is checked
Sample volume: 3 μl/test by testing 2 control specimens.

The calibration stability is at least 7 days.

Note: A recalibration is recommended when reagent lots change, and

when quality control results fall outside the range established.

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 ABX Pentra
Lactic Acid

Conversion factor:
mmol/l x 90 = mg/l
mmol/l x 9 = mg/dl

Application releasea: 2.xx

Warning
It is the user's responsibility to verify that this document is applicable
to the reagent used.

Reference
1. Thomas L., Lactate, In: Thomas L., editor. Clinical Laboratory
Diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998.
p. 160-166.
2. Trinder P. Determination of glucose in blood using glucose oxidase
with an alternative oxygen acceptor. Ann. Clin. Biochem., 1969, 6:
24.
3. Barhan D., Trinder P. An improved colour reagent for the
determination of blood glucose by the oxidase system. Analyst 97,
1972: 142.
4. Olson G.F., Optimal Conditions for the Enzymatic Determination of
L-Lactic Acid, Clin. Chem., Feb 1962, 8: 1-10.
5. Guder W.G., Zawta B., The Quality of Diagnostics Samples. Samples:
From the Patient to the Laboratory. 1st Ed. Guder W.G., Narayanan
S., Zawta B. (WHILEY-VCH, Darmstadt, Germany), (2001), 43.
6. Toffaletti J., Hammes M.E., Gray R., Lineberry B. and Abrams B.,
Lactate measured in diluted and undiluted whole blood and
plasma: comparison of methods and effect on hematocrit, Clin.
Chem., Dec 1992, 38: 2430-2434.
7. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de validation
de techniques (document B), Ann. Biol. Clin., 1986, 44, 686-745.
8. Evaluation of Precision Performance of Clinical Chemistry Devices,
Approved Guideline, CLSI (NCCLS) document EP5-A, Vol. 19, No. 2,
february 1999.
9. Evaluation of the Linearity of Quantitative Analytical Methods,
Approved Guideline, CLSI (NCCLS) document EP6-A, Vol. 23, No.
16, april 2003.
10. Method Comparison and Bias Estimation Using Patient Samples,
Approved Guideline, 2nd ed., CLSI (NCCLS) document EP9-A2, Vol.
22, No. 19, 2002.

a.Modification from index D to E: suppression of minor index.

S.A.S. au capital de 41.700.000 € - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
 ABX Pentra
Lactic Acid

S.A.S. au capital de 41.700.000 € - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com