DIAGNOSTICS

Clinical Chemistry,
Immunoassay Traceability,
Uncertainty of Measurement
ARCHITECT
TABLE OF CONTENTS
INTRODUCTION 1

CLINICAL CHEMISTRY ASSAYS 2

ENZYME ASSAYS 10

IMMUNOASSAYS 11
 1

Welcome to the Abbott Calibrator Traceability and Uncertainty of Measurement document.

This document provides information about the metrological traceability of calibrators used by the Abbott Clinical
Chemistry and Immunoassay tests and the uncertainty of measurement (MU), commonly known as uncertainty, for
these methods. The uncertainty data have been calculated following the International Organization for Standardization
(ISO) Guide to the Expression of Uncertainty in Measurement (GUM) and the Eurachem Guide for Quantitative
Uncertainty in Analytical Measurement (Eurachem/CITAC Guide).1,2
The available reference materials and reference measurement procedures of the highest metrological order for each
calibrator are listed. An internationally recognized reference material or procedure may not be available for some
analytes. For other analytes, there may be two or more materials or procedures. Those materials and procedures listed
in the database of the Joint Committee for Traceability in Laboratory Medicine (JCTLM) are preferentially used. For
the large number of analytes lacking a reference material and/or procedure, manufacturers anchor assays by preparing
calibrators using the materials and/or procedures considered most appropriate. Therefore, the actual target value of a
calibrator may vary from lot to lot. The values given in this document represent target concentrations, and calibrator
concentrations are given in both SI and conventional units, as appropriate.
The calibrator uncertainty estimates listed reflect typical values and may be used to calculate the total uncertainty
of a test result. The total uncertainty depends on a variety of separate uncertainties, including those attributable to
all absorbance readings; reagent, diluent and sample volumes; matrix effects; instrument drift; and intraindividual
biological variation. As such, calibrator uncertainty is a small portion of a test result’s total uncertainty. Total analytical
uncertainty is driven by the assay system’s analytical imprecision, including the assay and instrumentation. Additional
sources include preanalytical and postanalytical uncertainties contributed by individual laboratories.
Analytical error is the difference between an observed sample value and the true value. In contrast, uncertainty is an
estimate of the true value of a test result. According to metrological theory, the “true value” of a calibrator cannot be
known, and only the range of values in which the true value lies can be estimated. Uncertainty is an estimate typically
describing the 95 percent confidence limits for the true value of a specific calibrator. Uncertainty is not intended to
describe a performance specification for a calibrator but is a statistical description of the likelihood the true value of the
calibrator will be found in the cited range and within the stated confidence limits.

The Eurachem/CITAC Guide describes two methods for estimating uncertainty, commonly called the bottom-up and
top-down approaches. The bottom-up method includes all possible sources of uncertainty identified and quantified
in an uncertainty budget for a calibrator as it is manufactured. The uncertainties are statistically combined to produce
the expanded total uncertainty. The top-down method estimates the uncertainty of measurement produced by an assay
based on performance data. The calibrator uncertainties provided in this document are estimated primarily using the
top-down approach.

This document will be updated with additional calibrator and uncertainty of measurement information as data become
available.

References
1. ISO/BIPM Guide to the Expression of Uncertainty in Measurement (GUM), 2008. www.bipm.org/en/publications/guides/gum.html.
2. Ellison SLR, Williams A, eds. Eurachem/CITAC Guide: Quantifying Uncertainty in Analytical Measurement, 3rd edition, 2012. ISBN 978-0-
948926-30-3. www.eurachem.org.
Clinical Chemistry Traceability and Uncertainty of Measurement 2

CALIBRATOR REFERENCE
CONVEN- UNCERTAINTY
ASSAY LIST LIST CALIBRATOR NOMINAL MATERIAL REFERENCE
ASSAY NAME TIONAL (SI)
NUMBER NUMBER – LEVEL VALUE (SI) (STANDARD- METHOD
UNITS (SI) K=2
NAME IZATION)
1 18 (0.18) 0.966 (0.010)
2 45 (0.45) 2.415 (0.024)
A-1-AGP 6K45 – mg/dL ERM-DA470/ Immunoturbi-
6L34 3 90 (0.90) 4.830 (0.048)
Serum/Plasma Proteins Standard (g/L) IFCC dimetric
4 135 (1.35) 7.245 (0.072)
5 180 (1.80) 9.660 (0.097)
1 31 (0.31) 1.664 (0.017)
2 77.5 (0.78) 4.159 (0.042)
A1-AT 6K45 – mg/dL ERM-DA470/ Immunoturbi-
6K99 3 155 (1.55) 8.318 (0.083)
Serum/Plasma Proteins Standard (g/L) IFCC dimetric
4 232.5 (2.33) 12.477 (0.125)
5 310 (3.10) 16.636 (0.166)
Acetaminophen
2K99 –
Acetaminophen µg/mL Reference Stan-
2K99 Acetaminophen 1 151 (999.62) 2.013 (13.328) Gravimetric
Serum/Plasma (µmol/L) dard (98–100%
Calibrator
purity)
1E65 –
Albumin BCG g/dL 1 1.75 (17.5) 0.026 (0.258) Visible
7D53 Multiconstituent ERM-DA470
Serum/Plasma (g/L) 2 5.20 (52.0) 0.077 (0.767) spectrometry
Calibrator
1E65 –
Albumin BCP g/dL 1 1.75 (17.5) 0.030 (0.297) Visible
7D54 Multiconstituent ERM-DA470
Serum/Plasma (g/L) 2 5.20 (52.0) 0.088 (0.884) spectrometry
Calibrator
1 0.0 (0.00) N/A**
5P04 – 2 3.0 (5.20) 0.091 (0.155)
Amikacin TDM µg/mL 3 10.5 (17.89) 0.312 (0.533) USP grade
6L35 Gravimetric
Serum/Plasma Multiconstituent (µmol/L) 4 19.7 (33.62) 0.586 (1.002) Amikacin
Calibrator 5 34.2 (58.4136) 1.018 (1.742)
6 48.7 (83.19) 1.450 (2.480)
6K89 – Ultrapure
Ammonia Ultra µg/dL
6K89 Ammonia Ultra 1 500 (293.50) 10.000 (5.870) Ammonium Gravimetric
Plasma (µmol/L)
Calibrator Sulphate
1 500 (3.35) 33.333 (0.223) ≥99% pure
Amphetamine/ 3L43 –
ng/mL 2 1000 (6.70) 66.667 (0.447) Methampheta-
Methamphetamine 3L37 DOA MC I Volumetric
(µmol/L) 3 1500 (10.05) 100.000 (0.670) mine stock
Urine Calibrators 1-4
4 2000 (13.40) 133.33 (0.893) standard
5P56 –
mg/dL WHO/IFCC/
Apolipoprotein A1 Lipid Multi- Radioimmuno-
9D92 (g/L) 1 145 (1.445) 3.166 (0.032) CDC
Serum/Plasma constituent assay
Standard SP1-01
Calibrator
5P56 – WHO/IFCC/
mg/dL
Apolipoprotein B Lipid Multi- CDC Immuno-
9D93 (g/L) 1 117 (1.17) 3.401 (0.034)
Serum/Plasma constituent Standard nephelometry
Calibrator SP3-08
WHO
International
ASO 6K46 – IU/mL 20.000 Immunoturbi-
6K38 1 300 (300.00) Standard for
Serum ASO Standard (IU/mL) (20.000) dimetric
ASO, NIBSC
code: 97/662
1st WHO
International
6K47 – Standard for
B2-Microglobulin mg/L Immunoturbi-
6K39 B2-Microglobulin 1 4.0 (4.00) 0.267 (0.267) Beta-2
Serum/Plasma (mg/L) dimetric
Standard microgloblin,
NIBSC code:
B2M
1 100 (0.42) 6.667 (0.028)
3L43 – ≥99% pure
Barbiturates ng/mL 2 200 (0.84) 13.333 (0.056)
3L38 DOA MC I Secobarbital stock Volumetric
Urine (µmol/L) 3 500 (2.10) 33.333 (0.140)
Calibrators 1-4 standard
4 1000 (4.20) 66.667 (0.280)

*Assay not available in the United States.

**Uncertainty estimations are not calculated for 0 level calibrators.
CUSTOMER SERVICE: Contact your local representative or find country-specific contact information at www.abbottdiagnostics.com.
Clinical Chemistry Traceability and Uncertainty of Measurement 3

CALIBRATOR REFERENCE
CONVEN- UNCERTAINTY
ASSAY LIST LIST CALIBRATOR NOMINAL MATERIAL REFERENCE
ASSAY NAME TIONAL (SI)
NUMBER NUMBER – LEVEL VALUE (SI) (STANDARD- METHOD
UNITS (SI) K=2
NAME IZATION)
1 100 (0.35) 6.667 (0.023)
3L43 – ≥99% pure
Benzodiazepine ng/mL 2 200 (0.70) 13.333 (0.047)
3L39 DOA MC I Oxazepam stock Volumetric
Urine (µmol/L) 3 500 (1.75) 33.333 (0.117)
Calibrators 1-4 standard
4 1000 (3.50) 66.667 (0.233)
Internal standard
6K90 –
Bile Acids* µmol/L obtained from Nitrotetrazolium
6K90 Bile Acids 1 39 (0.04) 1.744 (0.002)
Serum (mmol/L) cholic acid blue/NADH
Calibrator
derivatives
1E66 –
Bilirubin, Direct mg/dL 1 0.8 (13.68) 0.018 (0.306)
8G63 Bilirubin Human Samples Doumas
Serum/Plasma (µmol/L) 2 8.2 (140.22) 0.183 (3.135)
Calibrator
1E66 –
Bilirubin, Total mg/dL 1 1.4 (23.94) 0.031 (0.535)
6L45 Bilirubin NIST SRM 916 Doumas
Serum/Plasma (µmol/L) 2 17.0 (290.70) 0.380 (6.500)
Calibrator
1E65 –
Calcium mg/dL 1 8.3 (2.08) 0.111 (0.028)
3L79 Multiconstituent NIST SRM 956 ID-ICP-MS
Serum/Plasma/Urine (mmol/L) 2 12.0 (3.00) 0.161 (0.040)
Calibrator
3L43 –
DOA MC Neg
1 0 (0.00) N/A** ≥99% pure
Cal
2 20 (0.06) 1.333 (0.004) 11-nor-
Cannabinoids 3L41 – ng/mL
3L41 3 50 (0.15) 3.333 (0.010) Δ9-THC-9- Volumetric
Urine Cannabinoids (µmol/L)
4 100 (0.29) 6.667 (0.019) carboxylic acid
Calibrators
5 200 (0.58) 13.333 (0.039) stock standard
20, 50, 100,
200
1 0.00 (0.00) N/A**
5P04 – 2 1.69 (7.15) 0.035 (0.149)
Carbamazepine TDM Multi- µg/mL 3 3.45 (14.59) 0.072 (0.305) USP grade
5P05 Gravimetric
Serum/Plasma constituent (µmol/L) 4 7.12 (30.12) 0.149 (0.629) Carbamazepine
Calibrator 5 11.16 (47.21) 0.233 (0.985)
6 18.37 (77.71) 0.383 (1.622)
1E64 –
Carbon Dioxide mEq/L 1 22 (22) 0.667 (0.667)
3L80 Carbon Dioxide NIST 351 Gravimetric
Serum/Plasma (mmol/L) 2 43 (43) 1.333 (1.333)
Calibrator
6K31 –
Ceruloplasmin mg/dL Immunoturbidi-
6K91 Plasmaproteins 1 95.0 (0.95) 4.478 (0.045) ERM-DA470
Serum/Plasma (g/L) metric
Calibrator
1E46 –
Chloride mmol/L Low 80.0 (80.0) 1.000 (1.000)
2P32 ICT Serum NIST SRM 2202 Silver Titration
Serum/Plasma (mmol/L) High 120.0 (120.0) 1.000 (1.000)
Calibrator
1E47 –
Chloride mmol/L Low 50 (50) 1.333 (1.333) NIST SRM 918
2P32 ICT Urine Silver Titration
Urine (mmol/L) High 180 (180) 1.333 (1.333) NIST SRM 919
Calibrator
Abell-Kendall
1E65 – SPRL Total
Cholesterol mg/dL 1 98 (2.54) 1.315 (0.034) procedure
7D62 Multiconstituent Cholesterol
Serum/Plasma (mmol/L) 2 384 (9.95) 5.152 (0.133) (CDC reference
Calibrator Verification Set
method)
6K30 – DGKC
Cholinesterase* U/L e Hexacyanofer-
6K24 Clin Chem 1 5350 (89.18) 131.048 (2.185) Butyrylthiocho-
Serum/Plasma (µkat/L) rate (III)
Calibrator line 37°C

6K25 – IFCC
CK-MB* U/L
6K25 CK-MB 1 110 (1.83) 3.01 (0.050) e NADP (immunoinhibi-
Serum/Plasma (µkat/L)
Calibrator tion)

1 150 (0.53) 10.000 (0.035)

3L43 – DOA ≥99% pure
Cocaine ng/mL 2 300 (1.05) 20.000 (0.070)
3L40 MC I Benzoylecgonine Volumetric
Urine (µmol/L) 3 500 (1.75) 33.333 (0.117)
Calibrators 1-4 stock standard
4 1000 (3.50) 66.667 (0.233)

*Assay not available in the United States.

**Uncertainty estimations are not calculated for 0 level calibrators.
CUSTOMER SERVICE: Contact your local representative or find country-specific contact information at www.abbottdiagnostics.com.
Clinical Chemistry Traceability and Uncertainty of Measurement 4

CALIBRATOR REFERENCE
CONVEN- UNCERTAINTY
ASSAY LIST LIST CALIBRATOR NOMINAL MATERIAL REFERENCE
ASSAY NAME TIONAL (SI)
NUMBER NUMBER – LEVEL VALUE (SI) (STANDARD- METHOD
UNITS (SI) K=2
NAME IZATION)
1 53 (0.53) 0.755 (0.008)
1E78 –
2 105 (1.05) 1.495 (0.015)
Complement C3 Specific Proteins mg/dL ERM-DA470/
9D96 3 175 (1.75) 2.492 (0.025) Gravimetric
Serum/Plasma Multiconstituent (g/L) IFCC
4 245 (2.45) 3.489 (0.035)
Calibrator
5 350 (3.50) 4.984 (0.050)
1 9 (0.09) 0.148 (0.001)
1E78 –
2 18 (0.18) 0.296 (0.003)
Complement C4 Specific Proteins mg/dL ERM-DA470/
9D97 3 30 (0.30) 0.493 (0.005) Gravimetric
Serum/Plasma Multiconstituent (g/L) IFCC
4 42 (0.42) 0.690 (0.007)
Calibrator
5 65 (0.65) 1.068 (0.011)
6K93 –
Copper* µg/dL
6K93 Copper 1 100 (15.73) 2.000 (0.315) NIST SRM 3114 Gravimetric
Serum (µmol/L)
Calibrator
1E65 –
Creatinine mg/dL 1 0.89 (78.23) 0.024 (2.10)
3L81 Multiconstituent NIST SRM 967 ID-LC/MS†
Serum/Plasma (µmol/L) 2 5.00 (442.00) 0.134 (11.86)
Calibrator
1E65 –
Creatinine mg/dL 1 1.40 (0.12) 0.038 (0.003)
3L81 Multiconstituent NIST SRM 914 Gravimetric
Urine (mmol/L) 2 5.40 (0.48) 0.145 (0.013)
Calibrator
Creatinine – 6K30 –
mg/dL 4.00
Enzymatic 8L24 Clin Chem 1 0.059 (5.197) NIST SRM 967 IDMS
(µmol/L) (353.60)
Serum/Plasma/Urine Calibrator
1 0.5 (5.00) 0.017 (0.167)
2 1.0 (10.00) 0.020 (0.200)
CRP Vario, 6K26 –
mg/dL 3 2.0 (20.00) 0.040 (0.400) ERM-DA472/ Immunoturbidi-
Standard Method 6K26 CRP Calibrator
(mg/L) 4 4.0 (40.00) 0.080 (0.800) IFCC metric
Serum/Plasma Set
5 16.0 (160.00) 0.320 (3.200)
6 32.0 (320.00) 0.640 (6.400)
1 0.25 (2.50) 0.008 (0.080)
6K26 –
CRP Vario, 2 0.5 (5.00) 0.017 (0.167)
CRP Calibrator
High Sensitivity mg/dL 3 1.0 (10.00) 0.020 (0.200) ERM-DA472/ Immunoturbidi-
6K26 HS
Method (mg/L) 4 2.0 (20.00) 0.040 (0.400) IFCC metric
and CRP
Serum/Plasma 5 8.0 (80.00) 0.160 (1.600)
Calibrator Set
6 16.0 (160.00) 0.320 (3.200)
1 0.5 (5.00) 0.017 (0.167)
6K26 –
2 1.0 (10.00) 0.020 (0.200)
CRP Vario, CRP Calibrator
mg/dL 3 2.0 (20.00) 0.040 (0.400) ERM-DA472/ Immunoturbidi-
Wide Range Method 6K26 Set
(mg/L) 4 4.0 (40.00) 0.080 (0.800) IFCC metric
Serum/Plasma and CRP
5 16.0 (160.00) 0.320 (3.200)
Calibrator WR
6 48.0 (480.00) 0.960 (9.600)
1P93 –
Cystatin C* mg/L ERM-DA 471/
1P93 Cystatin C 1 8 (8.00) 0.231 (0.231) Nephelometric
Serum/Plasma (mg/L) IFCC
Calibrator
In-house standard
assigned following
the recommen-
dations of the
Scientific and
7K02 – Standardization
D-Dimer* ng/mL Immunoturbidi-
7K02 D-Dimer 1 1600 (1600.00) 106.67 (106.67) Committee of
Plasma (ng/mL) metric
Standard the Interna-
tional Society
on Thrombosis
and Haemostasis
(SSC of the
ISTH)
DGKC
6K30 –
Dibucaine CHE Liquid* U/L e Hexacyanofer- Butyrylthio-
6K92 Clin Chem 1 1000 (16.67) 32.66 (0.544)
Serum/Plasma (µkat/L) rate (III) choline Inhibition
Calibrator
37°C

*Assay not available in the United States.

†
Use IDMS-traceable MDRD equation with factor 175 to estimate GFR.
CUSTOMER SERVICE: Contact your local representative or find country-specific contact information at www.abbottdiagnostics.com.
Clinical Chemistry Traceability and Uncertainty of Measurement 5

CALIBRATOR REFERENCE
CONVEN- UNCERTAINTY
ASSAY LIST LIST CALIBRATOR NOMINAL MATERIAL REFERENCE
ASSAY NAME TIONAL (SI)
NUMBER NUMBER – LEVEL VALUE (SI) (STANDARD- METHOD
UNITS (SI) K=2
NAME IZATION)
1 0 (0.00) N/A**
2 5 (6.55) 0.667 (0.873)
6K48 – USP Digitoxin
Digitoxin* ng/mL 3 10 (13.10) 1.333 (1.747)
6K40 Digitoxin Reference Gravimetric
Serum (nmol/L) 4 20 (26.20) 2.000 (2.620)
Standard Standards
5 40 (52.40) 4.000 (5.240)
6 80 (104.80) 8.000 (10.480)
1 0.0 (0.00) N/A**
2 0.5 (0.64) 0.067 (0.085)
1E06 – ng/mL 3 1.0 (1.28) 0.100 (0.128) USP grade
Gravimetric
Digoxin Calibrator (nmol/L) 4 2.0 (2.56) 0.133 (0.171) Digoxin
5 3.0 (3.84) 0.200 (0.256)
Digoxin 6 5.0 (6.40) 0.200 (0.256)
1E06
Serum/Plasma 1 0.0 (0.00) N/A**
5P04 – 2 0.5 (0.63) 0.012 (0.015)
TDM ng/mL 3 0.9 (1.19) 0.022 (0.028) USP grade
Gravimetric
Multiconstituent (nmol/L) 4 1.9 (2.41) 0.028 (0.036) Digoxin
Calibrator 5 2.9 (3.69) 0.043 (0.055)
6 4.7 (6.00) 0.070 (0.089)
3L42 – ≥99% pure
1 250 (1.30) 16.667 (0.087)
Ecstasy 3,4-Methylene-
Ecstasy ng/mL 2 500 (2.60) 33.333 (0.173)
3L42 Calibrators dioxymetham- Volumetric
Urine (µmol/L) 3 750 (3.90) 50.000 (0.260)
250, 500, 750, phetamine stock
4 1000 (5.20) 66.667 (0.347)
1000 standard
3L36 –
Ethanol mg/dL 1 0 (0.00) N/A** >99% pure
3L36 Ethanol Volumetric
Serum/Plasma/Urine (mmol/L) 2 100 (21.70) 6.667 (1.447) Ethanol Standard
Calibrator
3rd WHO
International
1 25 (25.00) 2.500 (2.500)
Standard for
Ferritin 6K49 – ng/mL 2 100 (100.00) 10.000 (10.000) Immunoturbidi-
6K41 Ferritin
Serum/Plasma Ferritin Standard (µg/L) 3 200 (200.00) 20.000 (20.000) metric
(recombinant),
4 500 (500.00) 50.000 (50.000)
NIBSC code:
94/572
6K94 – Glycated poly-
Fructosamine* µmol/L
6K94 Fructosamine 1 350 (350.00) 7.144 (7.144) L-lysine/14C- Gravimetric
Serum/Plasma (µmol/L)
Calibrator glucose
1 0.0 (0.00) N/A**
5P04 – 2 0.4 (0.88) 0.009 (0.018)
Gentamicin TDM µg/mL 3 1.4 (2.84) 0.028 (0.059) USP grade
1E11 Gravimetric
Serum/Plasma Multiconstituent (µmol/L) 4 2.8 (5.77) 0.082 (0.172) Gentamicin
Calibrator 5 5.1 (10.55) 0.151 (0.315)
6 8.4 (17.62) 0.251 (0.525)
Glucose 1E65 –
mg/dL 1 100 (5.55) 2.683 (0.149)
Serum/Plasma/ 3L82 Multiconstituent NIST SRM 965 ID-LC/MS
(mmol/L) 2 447.5 (24.84) 12.008 (0.666)
Urine/CSF Calibrator
1 41 (0.41) 0.898 (0.009)
1E78 –
2 83 (0.83) 1.818 (0.018)
Haptoglobin Specific Proteins mg/dL ERM-DA470/
9D91 3 138 (1.38) 3.023 (0.030) Gravimetric
Serum/Plasma Multiconstituent (g/L) IFCC
4 193 (1.93) 4.228 (0.042)
Calibrator
5 275 (2.75) 6.025 (0.060)

IFCC Monitoring NGSP (HPLC)

HbA1c 4P52 – 5.2 (33.32) 0.62% (0.350)
%NGSP 1 Program and IFCC
Whole Blood/ 4P52 HbA1c 11.6 (103.28) 0.63% (0.798)
(µmol/L-IFCC) 2 Reference (capillary
Hemolysate Calibrators
Sample electrophoresis)

6K30 –
HBDH Liquid* U/L
6K23 Clin Chem 1 250 (4.17) 6.124 (0.102) e NADH DGKC 37°C
Serum/Plasma (µkat/L)
Calibrator

*Assay not available in the United States.

**Uncertainty estimations are not calculated for 0 level calibrators.
CUSTOMER SERVICE: Contact your local representative or find country-specific contact information at www.abbottdiagnostics.com.
Clinical Chemistry Traceability and Uncertainty of Measurement 6

CALIBRATOR REFERENCE
CONVEN- UNCERTAINTY
ASSAY LIST LIST CALIBRATOR NOMINAL MATERIAL REFERENCE
ASSAY NAME TIONAL (SI)
NUMBER NUMBER – LEVEL VALUE (SI) (STANDARD- METHOD
UNITS (SI) K=2
NAME IZATION)
CDC Abell-
Kendall Refer-
5P56 – ence Method;
HDL, Ultra Lipid mg/dL Cholesterol
3K33 1 60 (1.55) 1.073 (0.028) Human Samples
Serum/Plasma Multiconstituent (mmol/L) Reference
Calibrator Method
Laboratory
Network
1 105 (1.05) 1.572 (0.016)
1E78 –
2 210 (2.10) 3.144 (0.031)
Immunoglobulin A Specific Proteins mg/dL ERM-DA470/
9D98 3 350 (3.50) 5.240 (0.052) Gravimetric
Serum/Plasma Multiconstituent (g/L) IFCC
4 490 (4.90) 7.336 (0.073)
Calibrator
5 700 (7.00) 10.480 (0.105)
2nd WHO
International
1 50 (50.00) 3.333 (3.333)
Reference
2 100 (100.00) 6.667 (6.667)
Immunoglobulin E 6K50 – IU/mL Preparation for Immunonephelo-
6K42 3 200 (200.00) 13.333 (13.333)
Serum/Plasma IgE Standard (IU/mL) Human Serum metric
4 500 (500.00) 33.333 (33.333)
Immunoglobulin
5 1000 (1000.00) 67.667 (67.667)
E, NIBSC code:
75/502

1 608 (6.08) 7.548 (0.075)

1E78 –
2 1215 (12.15) 15.084 (0.151)
Immunoglobulin G Specific Proteins mg/dL ERM-DA470/
9D99 3 2025 (20.25) 25.140 (0.251) Gravimetric
Serum/Plasma Multiconstituent (g/L) IFCC
4 2835 (28.35) 35.197 (0.352)
Calibrator
5 4250 (42.50) 52.764 (0.528)

1 50 (0.50) 0.803 (0.008)

1E78 –
2 99 (0.99) 1.591 (0.016)
Immunoglobulin M Specific Proteins mg/dL ERM-DA470/
1E01 3 165 (1.65) 2.651 (0.027) Gravimetric
Serum/Plasma Multiconstituent (g/L) IFCC
4 231 (2.31) 3.711 (0.037)
Calibrator
5 330 (3.30) 5.302 (0.053)

1E65 –
Iron µg/dL
6K95 Multiconstituent 1 100 (17.90) 2.236 (0.400) NIST SRM 3126 Gravimetric
Serum/Plasma (µmol/L)
Calibrator

6K31 –
Kappa Light Chains* mg/dL ERM-DA470/ Immunoturbidi-
6K96 Plasmaproteins 1 635 (6.35) 12.221 (0.122)
Serum/Plasma (g/L) IFCC metric
Calibrator

9D89 1 42.5 (4.72) 1.20 (0.13)

1E65 –
Lactic Acid mg/dL Reagent Grade
Multiconstituent Titration
Plasma (mmol/L) 1 10.00 (1.11) 0.18 (0.02) Lactic Acid
9P18 Calibrator
2 42.50 (4.72) 0.76 (0.08)

6K31 –
Lambda Light Chains* mg/dL ERM-DA470/ Immunoturbidi-
4P80 Plasmaproteins 1 382 (3.82) 7.352 (0.074)
Serum/Plasma (g/L) IFCC metric
Calibrator

CDC Abell-
Kendall Refer-
5P56 –
ence Method;
LDL Lipid mg/dL
1E31 1 127.5 (3.30) 2.281 (0.059) Human Samples Cholesterol
Serum/Plasma Multiconstituent (mmol/L)
Reference
Calibrator
Method Labora-
tory Network

Purified Human
Lipase 3E16 – U/L Pancreatic Lipase
7D80 1 240.5 (240.5) 4.033 (4.033) Gravimetric
Serum/Plasma Lipase Calibrator (U/L) (>900 U/L
activity)

6K30 –
Lithium mmol/L
8L25 Clin Chem 1 1.500 (1.500) 0.031 (0.031) NIST SRM 956 Colorimetric
Serum/Plasma (mmol/L)
Calibrator

*Assay not available in the United States.

CUSTOMER SERVICE: Contact your local representative or find country-specific contact information at www.abbottdiagnostics.com.
Clinical Chemistry Traceability and Uncertainty of Measurement 7

CALIBRATOR REFERENCE
CONVEN- UNCERTAINTY
ASSAY LIST LIST CALIBRATOR NOMINAL MATERIAL REFERENCE
ASSAY NAME TIONAL (SI)
NUMBER NUMBER – LEVEL VALUE (SI) (STANDARD- METHOD
UNITS (SI) K=2
NAME IZATION)
1 6 (6.00) 0.509 (0.509)
Internal
2 12 (12.00) 1.018 (1.018)
7K00 – mg/dL Reference
3 27 (27.00) 2.291 (2.291) ELISA
Lp(a) Standard (mg/dL) Material for
4 57 (57.00) 4.837 (4.837)
Lipoprotein(a)
Lp(a) 5 95 (95.00) 8.061 (8.061)
7K00
Serum/Plasma 1 8.5 (8.5) 0.186 (0.186)
Internal
2 18.0 (18.0) 0.394 (0.394)
5P83 – mg/dL Reference
3 35.0 (35.0) 0.767 (0.767) ELISA
Lp(a) Calibrators (mg/dL) Material for
4 67.5 (67.5) 1.479 (1.479)
Lipoprotein(a)
5 91.0 (91.0) 1.994 (1.994)
1E69 –
Magnesium mEq/L 1 0.85 (0.43) 0.016 (0.008)
7D70 Iron/Magnesium NIST SRM 956 ID-ICP-MS
Serum/Plasma/Urine (mmol/L) 2 3.40 (1.70) 0.065 (0.032)
Calibrator
1E65 –
Magnesium* mg/dL 1 1.20 (0.49) 0.032 (0.013)
3P68 Multiconstituent NIST SRM 956 ID-ICP/MS
Serum/Plasma/Urine (mmol/L) 2 4.70 (1.93) 0.126 (0.052)
Calibrator
1 150 (0.48) 10.000 (0.032)
3L43 – ≥99% pure
Methadone ng/mL 2 300 (0.96) 20.000 (0.064)
3L35 DOA MC I Methadone stock Volumetric
Urine (µmol/L) 3 500 (1.60) 33.333 (0.107)
Calibrators 1-4 standard
4 1000 (3.20) 66.667 (0.213)
1 5 (5.00) 0.333 (0.333)
2K98 – 2 25 (25.00) 1.000 (1.000)
Microalbumin µg/mL ERM-DA470/ Immunoturbidi-
2K98 Microalbumin 3 100 (100.00) 3.333 (3.333)
Urine (mg/L) IFCC metric
Calibrator 4 300 (300.00) 8.000 (8.000)
5 500 (500.00) 10.000 (10.000)
1 0.0 (0.00) N/A**
6L33 – 2 62.5 (62.50) 4.167 (4.167)
Myoglobin* ng/mL Immunoturbidi-
6L32 Myoglobin 3 125 (125.00) 8.333 (8.333) In-house standard
Serum/Plasma (ng/mL) metric
Standard 4 250 (250.00) 16.667 (16.667)
5 500 (500.00) 33.333 (33.333)
3L34 –
Opiates 1 150 (0.53) 10.000 (0.035)
Opiate ≥99% pure
Urine ng/mL 2 300 (1.05) 20.000 (0.070)
3L34 Calibrators Morphine stock Volumetric
For Opi2Q and Opi6SQ (µmol/L) 3 500 (1.75) 33.333 (0.117)
150, 300, 500, standard
applications 4 1000 (3.50) 66.667 (0.233)
1000
Opiates 1 1000 (3.50) 66.667 (0.233)
3L43 – ≥99% pure
Urine ng/mL 2 2000 (7.00) 133.333 (0.467)
3L34 DOA MC I Morphine stock Volumetric
For Opi3Q and Opi1SQ (µmol/L) 3 4000 (14.00) 266.667 (0.933)
Calibrators 1-4 standard
applications 4 6000 (21.00) 400.00 (1.400)
6K30 –
Pancreatic Amylase* U/L IFCC Liquid EPS
6K22 Clin Chem 1 170 (2.83) 4.164 (0.069) e p-Nitrophenol
Serum/Plasma (µkat/L) 37°C
Calibrator
1 12.5 (0.05) 1.000 (0.004)
3L43 – ≥99% pure
Phencyclidine ng/mL 2 25 (0.10) 1.667 (0.007)
6L96 DOA MC I Phencyclidine Volumetric
Urine (µmol/L) 3 50 (0.21) 3.333 (0.014)
Calibrators 1-4 stock standard
4 100 (0.41) 6.667 (0.027)
1 0.00 (0.00) N/A**
5P04 – 2 4.75 (20.47) 0.099 (0.427)
Phenobarbital TDM µg/mL 3 10.01 (43.14) 0.209 (0.900) USP grade
5P07 Gravimetric
Serum/Plasma Multiconstituent (µmol/L) 4 19.54 (84.22) 0.408 (1.758) Phenobarbital
Calibrator 5 39.65 (170.89) 0.827 (3.567)
6 77.50 (334.03) 1.617 (6.971)
1 0.00 (0.00) N/A**
5P04 – 2 2.45 (9.70) 0.058 (0.231)
Phenytoin TDM µg/mL 3 4.83 (19.13) 0.115 (0.456) USP grade
5P08 Gravimetric
Serum/Plasma Multiconstituent (µmol/L) 4 9.71 (38.45) 0.232 (0.917) Phenytoin
Calibrator 5 19.88 (78.72) 0.474 (1.878)
6 39.07 (154.72) 0.932 (3.690)
1E65 –
Phosphorus mg/dL 1 3.90 (1.26) 0.080 (0.026) NIST SRM
7D71 Multiconstituent Gravimetric
Serum/Plasma/Urine (mmol/L) 2 7.85 (2.54) 0.161 (0.052) 2186-I
Calibrator

*Assay not available in the United States.

**Uncertainty estimations are not calculated for 0 level calibrators.
CUSTOMER SERVICE: Contact your local representative or find country-specific contact information at www.abbottdiagnostics.com.
Clinical Chemistry Traceability and Uncertainty of Measurement 8

CALIBRATOR REFERENCE
CONVEN- UNCERTAINTY
ASSAY LIST LIST CALIBRATOR NOMINAL MATERIAL REFERENCE
ASSAY NAME TIONAL (SI)
NUMBER NUMBER – LEVEL VALUE (SI) (STANDARD- METHOD
UNITS (SI) K=2
NAME IZATION)
1E46 –
Potassium mmol/L Low 3.40 (3.40) 0.033 (0.033) Flame
2P32 ICT Serum NIST SRM
Serum/Plasma (mmol/L) High 8.0 (8.0) 0.050 (0.050) Photometry
Calibrator
1E47 –
Potassium mmol/L Low 9.0 (9.0) 0.133 (0.133) NIST SRM 918 Flame
2P32 ICT Urine
Urine (mmol/L) High 90 (90) 1.333 (1.333) NIST SRM 919 Photometry
Calibrator
1 5.0 (0.05) 0.100 (0.001)
6E57 – 2 15.0 (0.15) 0.301 (0.003)
Prealbumin mg/dL ERM-DA470/ Immunoturbidi-
1E02 Prealbumin 3 30.0 (0.30) 0.602 (0.006)
Serum (g/L) IFCC metric
Calibrator 4 45.0 (0.45) 0.904 (0.009)
5 60.0 (0.60) 1.205 (0.012)
1 150 (0.44) 10.000 (0.029)
3L43 – ≥99% pure
Propoxyphene ng/mL 2 300 (0.88) 20.000 (0.059)
6L97 DOA MC I Propoxyphene Volumetric
Urine (µmol/L) 3 500 (1.47) 33.333 (0.098)
Calibrators 1-4 stock standard
4 1000 (2.95) 66.667 (0.196)
1E65 –
Protein, Total g/dL 1 3.95 (39.50) 0.053 (0.530)
7D73 Multiconstituent NIST SRM 927 Biuret
Serum/Plasma (g/L) 2 7.00 (70.00) 0.094 (0.939)
Calibrator
1 0.0 (0.00) N/A**
5P04 – 2 0.5 (1.51) 0.015 (0.045)
Quinidine TDM µg/mL 3 0.9 (2.71) 0.026 (0.081) USP grade
6L31 Gravimetric
Serum/Plasma Multiconstituent (µmol/L) 4 1.9 (5.73) 0.055 (0.171) Quinidine
Calibrator 5 3.5 (10.84) 0.105 (0.323)
6 7.4 (22.70) 0.220 (0.677)
WHO Rheumatoid
RF* 6K52 – IU/mL Arthritis Serum, Immunoturbidi-
6K44 1 200 (200.00) 13.333 (13.333)
Serum RF Standard (IU/mL) NIBSC, 2010, metric
W 1066
1 10 (10.00) 0.533 (0.533) WHO International
8G67 –
2 20 (20.00) 1.067 (1.067) Standard Prepara-
Rheumatoid Factor Rheumatoid IU/mL Immunoturbidi-
8G66 3 40 (40.00) 1.867 (1.867) tion of Rheumatoid
Serum Factor (IU/mL) metric
4 120 (120.00) 2.400 (2.400) Arthritis Serum,
Calibrator
5 200 (200.00) 4.000 (4.000) NIBSC code: 64/2
3K01 –
Salicylate mg/dL USP grade Manual Trinder
3K01 Salicylate 1 20.7 (1.50) 0.207 (0.015)
Serum/Plasma (mmol/L) Salicylate Absorbance
Calibrator
6L36 – 1 25 (0.09) 1.667 (0.006) ≥99% pure
Serum Benzodiazepines ng/mL
6L30 Tox Calibrators 2 50 (0.18) 3.333 (0.012) Diazepam in-house Volumetric
Serum/Plasma (µmol/L)
1-3 3 100 (0.35) 6.667 (0.023) standard
1E46 –
Sodium mmol/L Low 120.0 (120.0) 1.000 (1.000) Flame
2P32 ICT Serum NIST SRM
Serum/Plasma (mmol/L) High 160.0 (160.0) 1.000 (1.000) Photometry
Calibrator
1E47 –
Sodium mmol/L Low 50 (50) 1.333 (1.333) NIST SRM 918 Flame
2P32 ICT Urine
Urine (mmol/L) High 180 (180) 1.333 (1.333) NIST SRM 919 Photometry
Calibrator
1 0.00 (0.00) N/A**
5P04 – 2 2.58 (14.32) 0.062 (0.342)
Theophylline TDM µg/mL 3 5.14 (28.53) 0.123 (0.680) USP grade
5P06 Gravimetric
Serum/Plasma Multiconstituent (µmol/L) 4 10.21 (56.67) 0.244 (1.352) Theophylline
Calibrator 5 20.65 (114.61) 0.493 (2.734)
6 39.28 (218.00) 0.937 (5.200)
1 0.0 (0.00) N/A**
2 0.5 (1.07) 0.017 (0.036)
7F93 –
Tobramycin µg/mL 3 1.5 (3.21) 0.050 (0.107) USP grade
7F93 Tobramycin Gravimetric
Serum/Plasma (µmol/L) 4 3.0 (6.42) 0.100 (0.214) Tobramycin
Calibrator
5 6.0 (12.84) 0.200 (0.428)
6 10.0 (21.40) 0.333 (0.713)
1 86 (0.86) 1.570 (0.016)
1E78 –
2 171 (1.71) 3.122 (0.031)
Transferrin Specific Proteins mg/dL ERM-DA470/
1E04 3 285 (2.85) 5.203 (0.052) Gravimetric
Serum/Plasma Multiconstituent (g/L) IFCC
4 399 (3.99) 7.285 (0.073)
Calibrator
5 530 (5.30) 9.676 (0.097)

*Assay not available in the United States.

**Uncertainty estimations are not calculated for 0 level calibrators.
CUSTOMER SERVICE: Contact your local representative or find country-specific contact information at www.abbottdiagnostics.com.
Clinical Chemistry Traceability and Uncertainty of Measurement 9

CALIBRATOR REFERENCE
CONVEN- UNCERTAINTY
ASSAY LIST LIST CALIBRATOR NOMINAL MATERIAL REFERENCE
ASSAY NAME TIONAL (SI)
NUMBER NUMBER – LEVEL VALUE (SI) (STANDARD- METHOD
UNITS (SI) K=2
NAME IZATION)

Tricyclic 6L36 – 1 150 (570.00) 10.000 (38.000) ≥99% pure

ng/mL
Antidepressants 6L28 Tox Calibrators 2 300 (1140.00) 20.000 (76.000) Nortriptyline in- Volumetric
(nmol/L)
Serum/Plasma 1-3 3 500 (1900.00) 33.333 (126.667) house standard

1E65 – Gas
Triglyceride mg/dL 1 93 (1.05) 2.080 (0.023) ACS Grade
7D74 Multiconstituent Chromatog-
Serum/Plasma (mmol/L) 2 470 (5.31) 10.510 (0.119) Glycerol
Calibrator raphy
UIBC 6K95-40 – µg/dL
4P79 1 500 (89.50) 10.000 (1.790) NIST SRM 3126 Gravimetric
Serum/Plasma UIBC Calibrator (µmol/L)
1E65 – Differential
Urea Nitrogen*** mg/dL 1 18 (6.43) 0.362 (0.129)
7D75 Multiconstituent NIST SRM 912 Scanning
Serum/Plasma/Urine (mmol/L) 2 56 (19.99) 1.127 (0.402)
Calibrator Calorimetry
1E65 –
Uric Acid mg/dL 1 4.05 (0.24) 0.105 (0.006)
3P39 Multiconstituent NIST SRM 913 Gravimetric
Serum/Plasma/Urine (mmol/L) 2 9.00 (0.53) 0.233 (0.014)
Calibrator
1 10 (100) 1.333 (13.333)
1E71 –
2 20 (200) 1.333 (13.333)
Urine/CSF Protein Urine/CSF mg/dL
7D79 3 40 (400) 1.333 (13.333) NIST SRM 927 Biuret
Urine/CSF Protein (mg/L)
4 80 (800) 2.667 (26.667)
Calibrator
5 200 (2000) 6.667 (66.667)
1 0.0 (0.00) N/A**
5P04 – 2 12.2 (84.27) 0.181 (1.256)
Valproic Acid TDM µg/mL 3 25.3 (175.05) 0.377 (2.610) USP grade
1E13 Gravimetric
Serum/Plasma Multiconstituent (µmol/L) 4 50.5 (349.90) 0.753 (5.216) Valproic Acid
Calibrator 5 100.9 (699.38) 1.504 (10.426)
6 135.7 (940.68) 2.023 (14.023)
1 0.0 (0.00) N/A**
5P04 – 2 5.0 (3.44) 0.148 (0.102)
Vancomycin TDM µg/mL 3 10.0 (6.87) 0.297 (0.205) USP grade
6E44 Gravimetric
Serum/Plasma Multiconstituent (µmol/L) 4 25.2 (17.35) 0.750 (0.517) Vancomycin
Calibrator 5 48.4 (33.41) 1.444 (0.996)
6 107.4 (74.10) 3.202 (2.209)

*Assay not available in the United States.

**Uncertainty estimations are not calculated for 0 level calibrators.
***7D75 Urea Nitrogen assay reports concentrations of urea nitrogen (mg/dl) in conventional
units and concentrations of urea (mmol/L) in SI units.

CUSTOMER SERVICE: Contact your local representative or find country-specific contact information at www.abbottdiagnostics.com.
Clinical Chemistry Traceability for the Enzyme Assays Using 10
Calibration Factors

ASSAY NAME ASSAY LIST NUMBER ASSAY SHORT NAME METHODOLOGY REFERENCE METHOD TRACEABILITY

Acid Phosphatase Alpha- Original Procedure,

9D87 ACP Molar extinction factor
Serum naphthylphosphate Hillman G. (1971)1
Alanine
Aminotransferase 7D56 ALT NADH without pyridoxal phosphate NADH molar extinction factor Molar extinction factor
Serum/Plasma
Alanine Aminotrans-
IFCC Reference Procedure
ferase Activated 8L92 A-ALT NADH with pyridoxal phosphate IFCC
(2002)2
Serum/Plasma
IFCC Reference Procedure
Alkaline Phosphatase IFCC
7D55 AlkP para-Nitrophenyl-phosphate (2011)3
Serum/Plasma
p-nitrophenol molar extinction factor Molar extinction factor
IFCC Reference Procedure
IFCC
Amylase 2-chloro-4-nitrophenyl-α-D- (2006)4
7D58 Amy
Serum/Plasma maltotrioside 2-chloro-4-nitrophenol
Molar extinction factor
molar extinction factor
Aspartate
Aminotransferase 7D81 AST NADH without pyridoxal phosphate NADH molar extinction factor Molar extinction factor
Serum/Plasma
Aspartate Aminotrans-
IFCC Reference Procedure
ferase Activated 8L91 A-AST NADH with pyridoxal phosphate IFCC
(2002)5
Serum/Plasma
Creatine Kinase IFCC Reference Procedure
7D63 CK NADPH IFCC
Serum/Plasma (2002)6
IFCC Reference Procedure
Gamma-glutamyl IFCC
L-Gamma-glutamyl-3-carboxy-4- (2002)7
Transferase 7D65 GGT
nitroanilide 3-carboxy-4-nitroalanine
Serum/Plasma Molar extinction factor
molar extinction factor
Lactate Dehydrogenase IFCC Reference Procedure
2P56 LDH Lactate to Pyruvate IFCC
Serum/Plasma (2002)8

1. Hillman G. Continuous. Photometric Measurement of Prostate Acid Phosphatase Activity. Z Klin Chem. Klin Biochem. 1971; 9:273-4.
2. Schumann G, Bonora R, Ceriotti F, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C. International Federation of Clinical
Chemistry and Laboratory Medicine. Part 4. Reference procedure for the measurement of catalytic concentration of alanine aminotransferase. Clin Chem Lab Med. 2002; 40(7):718-24.
3. Schumann G, Klauke R, Canalias F, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C. International Federation of Clinical
Chemistry and Laboratory Medicine. Part 9. Reference procedure for the measurement of catalytic concentration of alkaline phosphatase. Clin Chem Lab Med. 2011; 49(9):1439-46.
4. Schumann G, Aoki R, Ferrero CA, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C. International Federation of Clinical
Chemistry and Laboratory Medicine. Part 8. Reference procedure for the measurement of catalytic concentration of a-amylase. Clin Chem Lab Med. 2006; 44(9):1146-55.
5. Schumann G, Bonora R, Ceriotti F, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C. International Federation of Clinical
Chemistry and Laboratory Medicine. Part 5. Reference procedure for the measurement of catalytic concentration of aspartate aminotransferase. Clin Chem Lab Med. 2002; 40(7):725-33.
6. Schumann G, Bonora R, Ceriotti F, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C. International Federation of Clinical
Chemistry and Laboratory Medicine. Part 2. Reference procedure for the measurement of catalytic concentration of creatine kinase. Clin Chem Lab Med. 2002; 40(6):635-42.
7. Schumann G, Bonora R, Ceriotti F, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C. International Federation of Clinical
Chemistry and Laboratory Medicine. Part 6. Reference procedure for the measurement of catalytic concentration of gamma-glutamyltransferase. Clin Chem Lab Med. 2002; 40(7):734-8.
8. Schumann G, Bonora R, Ceriotti F, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C. International Federation of Clinical
Chemistry and Laboratory Medicine. Part 3. Reference procedure for the measurement of catalytic concentration of lactate dehydrogenase. Clin Chem Lab Med. 2002; 40(6):643-8.

*Assay not available in the United States.

CUSTOMER SERVICE: Contact your local representative or find country-specific contact information at www.abbottdiagnostics.com.
Immunoassay Traceability and Uncertainty of Measurement 11

REFERENCE
CALIBRA-
ASSAY LIST CONVENTIONAL CALIBRATOR NOMINAL UNCERTAINTY MATERIAL
ASSAY NAME TOR LIST
NUMBER UNITS LEVEL VALUE K=2 (STANDARD-
NUMBER
IZATION)
A 0.0 N/A**
Internal Reference
B 8.0 0.081
Active B12 Standard
C 16.0 0.162
(Holotranscobalamin) 3P24 3P24 pmol/L (Recombinant human
D 32.0 0.27
Serum holotranscobalamin
E 64.0 0.67
[rHTC])***
F 128.0 1.46
A 0 N/A**
B 15 0.06
AFP
C 45 0.18 WHO 1st International
Serum/Plasma/ 3P36 3P36 ng/mL
D 300 1.23 Standard 72/225
Amniotic Fluid
E 1500 8.54
F 2000 10.96
A 0.0 N/A**
B 5.0 0.04 Internal Reference
Anti-CCP C 25.0 0.17 Standard
1P65 1P65 U/mL
Serum/Plasma D 50.0 0.71 (Positive Human
E 100.0 1.42 Plasma)***
F 200.0 2.57
Anti-HBs* 1 0 N/A** WHO 1st International
7C18 7C18 mIU/mL
Serum/Plasma 2 100 1.10 Standard W1042
A 0 N/A**
B 10 0.04
Anti-HBs* C 50 0.11 WHO 2nd International
7C18 7C18 mIU/mL
Serum/Plasma D 100 0.22 Standard 07/164
E 500 1.42
F 1000 2.83
A 0.0 N/A**
B 5.0 0.06
Anti-Tg C 62.5 0.56 WHO 1st International
2K46 2K46 IU/mL
Serum/Plasma D 125.0 0.81 Standard 65/093
E 500.0 4.74
F 1000.0 11.30
A 0.0 N/A**
B 5.0 0.08
International Reference
Anti-TPO C 20.0 0.18
2K47 2K47 IU/mL Preparation MRC
Serum/Plasma D 62.5 0.46
66/387***
E 250.0 2.18
F 1000.0 8.74
A 0 N/A**
B 10 0.08
AUSAB# C 50 0.33 WHO 1st International
1L82 1L82 mIU/mL
Serum/Plasma D 100 0.64 Standard W1042
E 500 3.29
F 1000 7.44
A 0 N/A**
B 110 0.71
B12 C 250 1.61 USP Cyanocobalamin
7K61 7K61 pg/mL
Serum/Plasma D 500 2.06 Reference Standard
E 1000 4.11
F 2000 8.22
A 0 N/A**
B 10 0.10
BhCG Total C 250 2.56 WHO 4th International
7K78 7K78 mIU/mL
Serum/Plasma D 1000 4.63 Standard 75/589
E 7500 32.15
F 15000 64.30

*Assay not available in the United States.

#Assay available only in the United States.
**Uncertainty estimations are not calculated for 0 level calibrators.
***See the Calibrator Package Insert for more information.

CUSTOMER SERVICE: Contact your local representative or find country-specific contact information at www.abbottdiagnostics.com.
Immunoassay Traceability and Uncertainty of Measurement 12

REFERENCE
CALIBRA-
ASSAY LIST CONVENTIONAL CALIBRATOR NOMINAL UNCERTAINTY MATERIAL
ASSAY NAME TOR LIST
NUMBER UNITS LEVEL VALUE K=2 (STANDARD-
NUMBER
IZATION)
A 0 N/A**
B 75 0.76 Internal Reference
BNP C 375 2.62 Standard (Synthetic
8K28 8K28 pg/mL
Plasma D 750 8.23
E 2500 14.67 BNP-32 [human])***
F 5000 51.87
A 0.0 N/A**
B 44.0 0.424 Internal Reference
BNP-JP§ C 218.0 2.079 Standard (Synthetic
2P14 2P14 pg/mL
Plasma D 435.0 2.97
E 1451.0 6.65 BNP-32 [human])***
F 2902.0 9.79
A 0 N/A**
B 20 0.13 Internal Reference
CA 125 II C 75 0.50 Standard (OC125
2K45 2K45 U/mL
Serum/Plasma D 225 1.56
E 500 3.75 Defined Antigen)***
F 1000 7.50
A 0 N/A**
B 20 0.13 Internal Reference
CA 15-3 C 80 0.54 Standard (DF3 Defined
2K44 2K44 U/mL
Serum/Plasma D 160 1.09
E 400 3.64 Antigen)***
F 800 8.52
A 0 N/A**
B 30 0.51 Internal Reference
CA 19-9xr C 100 0.89 Standard
2K91 2K91 U/mL (1116-NS-19-9 Defined
Serum/Plasma D 250 2.05
E 600 7.78 Antigen)***
F 1200 20.04
A 0.00 N/A**
USP Carbamazepine
B 2.00 0.011
Reference Standard
iCarbamazepine C 4.00 0.017
1P36 1P36 μg/mL (5H-Dibenz[b,f]
Serum/Plasma D 8.00 0.03
azepine-
E 12.00 0.06
5-carboxamide)
F 20.00 0.10
CEA 1 0 N/A** WHO 1st International
7K68 7K68 ng/mL
Serum/Plasma 2 10 0.08 Standard 73/601
A 0.0 N/A**
B 3.8 0.03 Internal Reference
Stat CK-MB C 12.0 0.09 Standard (Recombinant
2K42 2K42 ng/mL
Serum/Plasma D 60.0 0.55
E 135.0 1.24 CK-MB)***
F 300.0 2.75
A 0 N/A**
B 10.0 0.03 Internal Reference
CMV IgG* C 50.0 0.13 Standard (Human Anti-
6C15 6C15 AU/mL
Serum/Plasma D 75.0 0.20
E 125.0 0.33 CMV IgG)***
F 250.0 0.75
A 0.0 N/A**
B 3.0 0.03 Internal Reference
Cortisol C 5.4 0.07 Standard (Cortisol USP
8D15 8D15 µg/dL
Serum/Plasma/Urine D 10.7 0.10
E 25.2 0.23 Standard)***
F 59.8 0.45
A 0.00 N/A**
B 0.05 0.0004
C-Peptide C 0.24 0.002 WHO International
3L53 3L53 ng/mL
Serum/Plasma/Urine D 1.20 0.01 Standard 84/510
E 6.00 0.03
F 30.00 0.14

*Assay not available in the United States.

**Uncertainty estimations are not calculated for 0 level calibrators.
§
Assay available only in Japan.
***See the Calibrator Package Insert for more information.
CUSTOMER SERVICE: Contact your local representative or find country-specific contact information at www.abbottdiagnostics.com.
Immunoassay Traceability and Uncertainty of Measurement 13

REFERENCE
CALIBRA-
ASSAY LIST CONVENTIONAL CALIBRATOR NOMINAL UNCERTAINTY MATERIAL
ASSAY NAME TOR LIST
NUMBER UNITS LEVEL VALUE K=2 (STANDARD-
NUMBER
IZATION)
A 0 N/A**
B 40 1.08
Cyclosporine C 150 3.12 USP Cyclosporine
1L75 1L75 ng/mL
Whole Blood D 400 7.23 Reference Standard
E 800 13.37
F 1500 28.86
A 0.0 N/A**
B 2.5 0.021 Maintained Reference
CYFRA 21-1* C 10.0 0.067 Preparation
2P55 2P55 ng/mL
Serum/Plasma D 25.0 0.170 (Cytokeratin 8/19
E 50.0 0.300 Antigen)
F 100.0 0.610
Internal Reference
A 0 N/A** Standard (Purified
B 5 0.02 Synthetic DHEA-S),
DHEA-S C 12 0.04 Sigma D5297;
8K27 8K27 µg/dL Dehydroisoandro-
Serum/Plasma D 60 0.07
E 300 0.34 sterone
F 1500 1.88 3-sulfate sodium salt
dihydrate***
A 0.0 N/A**
B 0.5 0.005
i Digoxin C 1.0 0.01 USP Digoxin Reference
1P32 1P32 ng/mL
Serum/Plasma D 2.0 0.01 Standard
E 3.0 0.02
F 4.0 0.03
A 0 N/A**
B 50 0.74 Internal Reference
Estradiol C 100 1.47 Standard
7K72 7K72 pg/mL
Serum/Plasma D 250 1.30
E 500 2.30 (ß-Estradiol)***
F 1000 4.60
WHO Ferritin 1st
Ferritin 1 10 0.13
7K59 7K59 ng/mL International
Serum/Plasma 2 1000 12.75
Standard 80/602
A 0.0 N/A**
B 1.5 0.01
Folate II* WHO Serum Folate
C 3.0 0.02
Serum/Plasma/ 1P74 1P74 ng/mL International
D 5.0 0.03
Red Blood Cells Standard 03/178
E 10.0 0.05
F 20.0 0.09

A 0.0 N/A**
B 1.5 0.01
WHO Serum Folate
Folate# C 3.0 0.02
1P74 1P74 ng/mL International
Serum/Plasma D 5.0 0.03
Standard 03/178
E 10.0 0.05
F 20.0 0.09
Free PSA* 1 0 N/A** WHO 1st International
7K71 7K71 ng/mL
Serum 2 10 0.09 Standard 96/670

*Assay not available in the United States.

**Uncertainty estimations are not calculated for 0 level calibrators.
#Assay available only in the United States.
***See the Calibrator Package Insert for more information.

CUSTOMER SERVICE: Contact your local representative or find country-specific contact information at www.abbottdiagnostics.com.
Immunoassay Traceability and Uncertainty of Measurement 14

REFERENCE
CALIBRA-
ASSAY LIST CONVENTIONAL CALIBRATOR NOMINAL UNCERTAINTY MATERIAL
ASSAY NAME TOR LIST
NUMBER UNITS LEVEL VALUE K=2 (STANDARD-
NUMBER
IZATION)
Free PSA# 1 0 N/A** WHO 1st International
6C07 6C07 ng/mL
Serum 2 10 0.09 Standard 96/670
Internal Reference
Standard (L-Triiodo-
Free T3 1 1.4 0.01 thyronine sodium salt,
7K63 7K63 pg/mL and L-Thyroxine
Serum/Plasma 2 30.0 0.26
sodium pentahy-
drate)***
A 0.0 N/A**
B 0.5 0.005 Internal Reference
Free T4 C 1.0 0.005 Standard (L-Thyroxine
7K65 7K65 ng/dL
Serum/Plasma D 2.0 0.009 Sodium
E 3.5 0.038 Pentahydrate)***
F 6.0 0.128
FSH 1 0 N/A** WHO 1st International
7K75 7K75 mIU/mL
Serum/Plasma 2 100 0.84 Standard 92/510
A 0.0 N/A**
B 5.7 0.08 Maintained Reference
Galectin-3* C 11.4 0.11 Preparation
5P03 5P03 ng/mL
Serum/Plasma D 22.8 0.24 (Recombinant
E 68.4 1.08 Human Galectin-3)
F 114.0 1.67
A 0.00 N/A**
USP Gentamicin
B 0.30 0.001
Reference
iGentamicin C 1.50 0.003
1P31 1P31 μg/mL Standard
Serum/Plasma D 5.00 0.014
(Gentamicin
E 8.00 0.031
sulfate salt)
F 10.00 0.042

A 4.0 0.029
B 5.5 0.040 Internal Reference
HbA1c C 7.5 0.051 Standard
4P72 4P72 nmol/L (IFCC
Whole Blood D 9.0 0.07
E 12.0 0.09 Reference Standard)***
F 14.5 0.11

A 0.00 N/A**
B 0.70 0.03
Reference Standard
HBeAg Quantitative* C 1.50 0.06
6C32 7P24 PEI U/mL HBe-Referenzantigen
Serum/Plasma D 10.00 0.42
82
E 150.00 6.51
F 700.00 32.20
HBsAg* 1 0.5 0.01 WHO International
6C36 3M61 IU/mL
Serum/Plasma 2 250 4.43 Standard 80/549
A 0.0 N/A**
B 0.5 0.00
HBsAg* C 5.0 0.01 WHO International
6C36 3M61 IU/mL
Serum/Plasma D 28.0 0.06 Standard 80/549
E 100.0 0.28
F 250.0 0.60

*Assay not available in the United States.

#Assay available only in the United States.
**Uncertainty estimations are not calculated for 0 level calibrators.
***See the Calibrator Package Insert for more information.

CUSTOMER SERVICE: Contact your local representative or find country-specific contact information at www.abbottdiagnostics.com.
Immunoassay Traceability and Uncertainty of Measurement 15

REFERENCE
CALIBRA-
ASSAY LIST CONVENTIONAL CALIBRATOR NOMINAL UNCERTAINTY MATERIAL
ASSAY NAME TOR LIST
NUMBER UNITS LEVEL VALUE K=2 (STANDARD-
NUMBER
IZATION)

Internal Reference
A 0.00 N/A** Standard (Cal B-D:
B 10.00 0.18 Recombinant
HCV Ag* C 80.00 1.32 HCV Core Ag,
6L47 6L47 fmol/L
Serum/Plasma D 600.00 9.15 Cal E-F: Lactose
E 4500.00 62.03 Recombinant
F 20000.00 275.67
HCV Core Ag)***

Internal Reference
A 0 N/A** Standard (Recombinant
B 30 0.27 Ig-HE4
HE4 C 100 0.88 fusion protein consisting
2P54 2P54 pmol/L of a Human Fc antibody
Serum D 250 2.18
E 750 6.47 fragment and Human
F 1500 13.82 Epidydimis protein
[HE4])***
A 0.0 N/A**
B 2.5 0.03 Internal Reference
Homocysteine C 5.0 0.06 Standard (S-adenosyl-
1L71 1L71 µmol/L L-homocystein
Serum/Plasma D 10.0 0.08
E 20.0 0.16 in phosphate buffer)***
F 50.0 0.33
Internal Reference
Standard
A 0 N/A** (Recombinant Human
B 20 2.8 Cardiac
Stat High Sensitive
C 100 14.1 Troponin IC Complex).
Troponin-I* 3P25 3P25 pg/mL
D 500 70.7 Calibrator B is
Serum/Plasma
E 10000 1414.2 traceable to
F 50000 7071.1 NIST SRM 2921
at 20 pg/mL.***
A 0 N/A**
B 3 0.03
Insulin C 10 0.09 WHO 1st International
8K41 8K41 µU/mL
Serum/Plasma D 30 0.17 Standard 66/304
E 100 0.48
F 300 1.44
A 0.0 N/A**
B 4.8 0.02
Intact PTH C 24.0 0.10 WHO 1st International
8K25 8K25 pg/mL
Serum/Plasma D 120.0 0.27 Standard 79/500
E 600.0 1.21
F 3000.0 6.07
A 0.0 N/A**
B 1.0 0.01
WHO 2nd
LH C 3.5 0.02
2P40 2P40 mIU/mL International
Serum/Plasma D 15.0 0.08
Standard 80/552
E 50.0 0.30
F 250.0 1.56
A 0.000 N/A**
B 0.040 0.000
Methotrexate
Methotrexate* C 0.100 0.001
2P49 2P49 μmol/L Reference
Serum/Plasma D 0.250 0.002
Standard (USP)
E 0.700 0.005
F 1.500 0.014
A 0.0 N/A**
B 30.0 0.33 Internal Reference
Stat Myoglobin C 100.0 0.99 Standard (Purified
2K43 2K43 ng/mL human cardiac
Serum/Plasma D 300.0 3.18
E 600.0 5.69 myoglobin)***
F 1200.0 11.38

*Assay not available in the United States.

**Uncertainty estimations are not calculated for 0 level calibrators.
***See the Calibrator Package Insert for more information.

CUSTOMER SERVICE: Contact your local representative or find country-specific contact information at www.abbottdiagnostics.com.
Immunoassay Traceability and Uncertainty of Measurement 16

REFERENCE
CALIBRA-
ASSAY LIST CONVENTIONAL CALIBRATOR NOMINAL UNCERTAINTY MATERIAL
ASSAY NAME TOR LIST
NUMBER UNITS LEVEL VALUE K=2 (STANDARD-
NUMBER
IZATION)
A 0.0 N/A**
B 10.0 0.04 Internal Reference
Urine NGAL* C 100.0 0.28 Standard (Recombinant
1P37 1P37 ng/mL
Urine D 500.0 1.51
E 1000.0 2.45 human NGAL)***
F 1500.0 3.68
Internal Reference
Pepsinogen I* 1 0 N/A** Standard (Pepsinogen I
8D07 8D07 ng/mL
Serum/Plasma 2 70 1.92
Antigen)***
Internal Reference
Pepsinogen II* 1 0 N/A** Standard (Pepsinogen II
9D65 9D65 ng/mL
Serum/Plasma 2 5 0.13
Antigen)***
A 0.0 N/A**
B 2.5 0.02
i Phenytoin C 5.0 0.03 USP Phenytoin
1P34 1P34 µg/mL
Serum/Plasma D 10.0 0.07 Reference Standard
E 20.0 0.14
F 40.0 0.36
A 0.0 N/A**
B 5.0 0.04
i Phenobarbital C 10.0 0.08 USP Phenobarbital
1P33 1P33 µg/mL
Serum/Plasma D 20.0 0.16 Reference Standard
E 40.0 0.31
F 80.0 1.31
A 0 N/A**
B 40 0.8000 Internal Reference
PIVKA-II* C 100 1.5600 Standard
2P48 2P48 mAU/mL (purified human
Serum/Plasma D 300 4.3800
E 5000 124.0000 prothrombin)***
F 30000 1062.0000
USP
Progesterone 1 0.7 0.01
7K77 7K77 ng/mL Progesterone
Serum/Plasma 2 40.0 0.26
Reference Standard
A 0.0 N/A**
B 20.0 0.18 Internal Reference
ProGRP* C 80.0 0.78 Standard (Synthetic
1P45 1P45 pg/mL
Serum/Plasma D 320.0 2.86
E 1250.0 11.18 ProGRP)***
F 5000.0 33.54
WHO 3rd
Prolactin 1 5 0.05
7K76 7K76 ng/mL International
Serum/Plasma 2 30 0.23
Standard 84/500
A 0 N/A**
B 5 0.09
Rubella IgG* C 15 0.26 WHO 1st International
6C17 6C17 IU/mL
Serum/Plasma D 75 1.21 Standard RUBI-1-94
E 250 6.30
F 500 13.54
A 0 N/A**
B 1 0.01 Internal Reference
SCC* C 5 0.05 Standard (SCC Stock
8D18 8D18 ng/mL
Serum/Plasma D 20 0.21
E 40 0.42 Antigen)***
F 70 0.67
A 0.0 N/A**
B 2.0 0.01
SHBG C 6.0 0.03 WHO 2nd International
8K26 8K26 nmol/L
Serum/Plasma D 25.0 0.07 Standard 08/266
E 125.0 0.81
F 250.0 0.93

*Assay not available in the United States.

**Uncertainty estimations are not calculated for 0 level calibrators.
***See the Calibrator Package Insert for more information.

CUSTOMER SERVICE: Contact your local representative or find country-specific contact information at www.abbottdiagnostics.com.
Immunoassay Traceability and Uncertainty of Measurement 17

REFERENCE
CALIBRA-
ASSAY LIST CONVENTIONAL CALIBRATOR NOMINAL UNCERTAINTY MATERIAL
ASSAY NAME TOR LIST
NUMBER UNITS LEVEL VALUE K=2 (STANDARD-
NUMBER
IZATION)
A 0 N/A** Internal Reference
B 3 0.05 Standard (Sirolimus
Sirolimus C 6 0.07 powder, purity ≥ 92%
1L76 1L76 ng/mL
Whole Blood D 12 0.14 as anhydrous
E 20 0.20
F 30 0.30 powder)***

A 0 N/A** Internal Reference

B 3 0.04 Standard (Tacrolimus
Tacrolimus C 6 0.06 powder, purity
1L77 1L77 ng/mL
Whole Blood D 12 0.13 ≥ 98.0% as anhydrous
E 20 0.23
F 30 0.34 powder)***

A 0.0 N/A**
B 0.1 0.001
2nd Generation USP Testosterone
C 0.2 0.002
Testosterone 2P13 2P13 nmol/L Reference
D 1.6 0.01
Serum/Plasma Standard
E 12.5 0.08
F 30.0 0.19
A 0.0 N/A**
B 2.5 0.03
i Theophylline C 5.0 0.06 USP Theophylline
1P29 1P29 µg/mL
Serum/Plasma D 10.0 0.13 Reference Standard
E 20.0 0.23
F 40.0 0.47
WHO 1st International
Total PSA* 1 0 N/A**
7K70 7K70 ng/mL Standard (90:10)
Serum 2 15 0.17
96/670
WHO 1st International
Total PSA# 1 0 N/A**
6C06 6C06 ng/mL Standard (90:10)
Serum 2 15 0.17
96/670
Total T3 1 0.5 0.006 USP L-Triiodothyronine
7K64 7K64 ng/mL
Serum/Plasma 2 8.0 0.058 Reference Standard
Total T4 1 0.0 N/A** USP L-Thyroxine
7K66 7K66 µg/dL
Serum/Plasma 2 18.0 0.213 Reference Standard
A 0 N/A**
B 3 0.027
Total T4 C 6 0.049 USP L-Thyroxine
7K66 7K66 µg/dL
Serum/Plasma D 12 0.143 Reference Standard
E 18 0.215
F 24 0.287
A 0.00 N/A** Internal Reference
B 0.25 0.003 Standard (Recombinant
Stat Troponin-I C 0.50 0.005 Troponin IC
2K41 2K41 ng/mL
Serum/Plasma D 1.50 0.012
E 10.00 0.067 Complex)***
F 50.00 0.397
A 0.0 N/A**
B 5.0 0.01
Toxo IgG* C 25.0 0.05 WHO 1st International
6C19 6C19 IU/mL
Serum/Plasma D 50.0 0.11 Standard 01/600
E 100.0 0.33
F 200.0 0.66
TSH 1 0.0 N/A** WHO International
7K62 7K62 µIU/mL
Serum/Plasma 2 40.0 0.288 Standard 80/558
A 0.00 N/A**
B 0.40 0.004 Internal Reference
T-Uptake C 0.67 0.004 Standard (normal
2K48 2K48 T-Uptake Units human serum, T4
Serum/Plasma D 1.09 0.005
E 1.42 0.01 binding capacity)***
F 1.89 0.01

*Assay not available in the United States.

#Assay available only in the United States.
**Uncertainty estimations are not calculated for 0 level calibrators.
***See the Calibrator Package Insert for more information.
CUSTOMER SERVICE: Contact your local representative or find country-specific contact information at www.abbottdiagnostics.com.
Immunoassay Traceability and Uncertainty of Measurement 18

REFERENCE
CALIBRA-
ASSAY LIST CONVENTIONAL CALIBRATOR NOMINAL UNCERTAINTY MATERIAL
ASSAY NAME TOR LIST
NUMBER UNITS LEVEL VALUE K=2 (STANDARD-
NUMBER
IZATION)
A 0.00 N/A**
B 9.00 0.08
i Valproic Acid C 18.00 0.16 USP Valproic Acid
1P35 1P35 µg/mL
Serum/Plasma D 36.00 0.26 Reference Standard
E 75.00 0.68
F 150.00 1.22
A 0.0 N/A**
B 5.0 0.05
USP Vancomycin
i Vancomycin C 10.0 0.09
1P30 1P30 µg/mL Hydrochloride
Serum/Plasma D 25.0 0.24
Reference Standard
E 50.0 0.51
F 100.0 1.21

A 0.0 N/A** Internal Reference

B 4.0 0.038 Standard
25-OH Vitamin D C 10.0 0.094 (25-OH Vitamin D3),
3L52 3L52 ng/mL Sigma 17938;
Serum/Plasma D 30.0 0.252
E 75.0 0.444 25-Hydroxyvitamin D3
F 160.0 0.984 monohydrate***

A 0.0 N/A**
B 4.0 0.22
NIST Standard
25-OH Vitamin D C 10.0 0.42
5P02 5P02 ng/mL Reference
Serum/Plasma D 30.0 1.24
Material (SRM) 2972
E 75.0 3.02
F 160.0 8.03

ACS–American Chemical Society

ERM–European Reference Material
GFR–Glomerular Filtration Rate
ID-ICP-MS–Isotope Dilution Inductively Coupled Plasma Mass Spectrometry
ID-LC/MS–Isotope Dilution-Liquid Chromatography Mass Spectrometry
MDRD–Modification of Diet in Renal Disease
NIST–National Institute of Standards and Technology
SRM–Standard Reference Material

*Assay not available in the United States.

**Uncertainty estimations are not calculated for 0 level calibrators.
***See the Calibrator Package Insert for more information.

CUSTOMER SERVICE: Contact your local representative or find country-specific contact information at www.abbottdiagnostics.com.
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