Uncertainty calculation for calibrators and controls of laboratory diagnostic assays
-
Andrea Konnert
Abstract
The uncertainty of the results from calibrators and controls is an important component of the overall uncertainty of the results of medical samples. The purpose of this note is to review procedures of standardization and to describe the respective calculation of the uncertainty components for calibrators and controls of commercial routine diagnostic assays. The authors hope that the laying out of the procedures for uncertainty calculation of routine calibrators and controls contributes (i) to the transparency on how this component of uncertainty is derived and (ii) to a better understanding and use of the uncertainty concept in the routine laboratory.
Clin Chem Lab Med 2006;44:1175–82.
References
1. International Organization for Standardization. General requirements for the competence of testing and calibration (ISO/IEC 17025:2005). Geneva: ISO, 2005.Search in Google Scholar
2. International Organization for Standardization. Medical laboratories – particular requirements for quality and competence (ISO 15189:2003). Geneva: ISO, 2003.Search in Google Scholar
3. International Organization for Standardization. Guide to the expression of uncertainty in measurement. Geneva: ISO, 1995.Search in Google Scholar
4. Krouwer JS. Critique of the guide to the expression of uncertainty in measurement method of estimating and reporting uncertainty in diagnostic assays. Clin Chem 2003; 49:1818–21.10.1373/clinchem.2003.019505Search in Google Scholar PubMed
5. Thienpont LM, Van Uytfanghe K, Cabaleiro DR. Metrological traceability of calibration in the estimation and use of common medical decision-making criteria. Clin Chem Lab Med 2004; 42:842–50.10.1515/CCLM.2004.138Search in Google Scholar PubMed
6. Kristiansen J. The Guide to expression of uncertainty in measurement approach for estimating uncertainty: an appraisal. Clin Chem 2003; 49:1822–9.10.1373/clinchem.2003.021469Search in Google Scholar PubMed
7. Linko S, Örnemark U, Kessel R, Taylor PD. Evaluation of uncertainty of measurement in routine clinical chemistry – applications to determination of the substance concentration of calcium and glucose in serum. Clin Chem Lab Med 2002; 40:391–8.10.1515/CCLM.2002.063Search in Google Scholar PubMed
8. http://physics.nist.gov/cuu/Uncertainty/index.html. Assessed July 3, 2006.Search in Google Scholar
9. http://www.measurementuncertainty.org. Assessed July 3, 2006.Search in Google Scholar
10. Cox MG, Harris PM. Uncertainty evaluation, software support for metrology – best practice guide No. 6. Teddington: National Physics Laboratory, 2004.Search in Google Scholar
11. Philips SD, Eberhardt KR. Guidelines for expressing the uncertainty of measurement results containing uncorrected bias. J Res Natl Stand Tech 1997; 102:577.10.6028/jres.102.039Search in Google Scholar PubMed PubMed Central
12. Haesselbarth W. Accounting for bias in measurement uncertainty estimation. J Accred Qual Assur 2004; 9:509–14.10.1007/s00769-004-0782-5Search in Google Scholar
13. O'Donnell GE, Hibbert DB. Treatment of bias in estimating measurement uncertainty. Analyst 2005; 130:721–9.10.1039/b414843fSearch in Google Scholar PubMed
14. Neter J, Wassermann W, Kutner MH. Applied linear statistical models. Homewood: Irwin, 1985.Search in Google Scholar
15. Konnert A, Schubert S, Arends S, Berding C, Weykamp C, Siebelder C. Uncertainty calculation for calibrators of the IFCC HbA1c standardization network. J Accred Qual Assur 2006; DOI: 10.1007/s00769-006-0113-0.10.1007/s00769-006-0113-0Search in Google Scholar
16. Linnet K. Evaluation of regression procedures for method comparison studies. Clin Chem 1993; 39:424–32.10.1093/clinchem/39.3.424Search in Google Scholar
17. Wu CF. Jackknife, bootstrap and other resampling methods in regression analysis. Ann Stat 1986; 14:1261–95.Search in Google Scholar
18. Cheng CL, Van Ness JW. Statistical regression with measurement error. New York: Oxford University Press, 1999.Search in Google Scholar
19. Clinical and Laboratory Standards Institute. Metrological traceability and its implementation; a report. CLSI document X5-R (ISBN 1-56238-598-4). Wayne: CLSI, 2006.Search in Google Scholar
20. Searle S, Casella G, McCulloch C. Variance components. New York: John Wiley, 1992.10.1002/9780470316856Search in Google Scholar
21. Konnert A, Berding C. The statistical basis of standardization designs for diagnostic assays. J Accred Qual Assur 2004; 9:457–63.10.1007/s00769-004-0817-ySearch in Google Scholar
©2006 by Walter de Gruyter Berlin New York
Articles in the same Issue
- Multiplexed testing in the autoimmunity laboratory
- Uncertainty calculation for calibrators and controls of laboratory diagnostic assays
- Westgard multirule for calculated laboratory tests
- Frequency of a single nucleotide (A2317G) and 56-bp variable number of tandem repeat polymorphisms within the deoxyribonuclease I gene in five ethnic populations
- The influence of genetic polymorphisms of cytochrome P450 3A5 and ABCB1 on starting dose- and weight-standardized tacrolimus trough concentrations after kidney transplantation in relation to renal function
- Apolipoprotein B gene 3′VNTR polymorphism: association with plasma lipids and coronary heart disease in Han Chinese
- Paraoxonase-1 (PON1) activity, but not PON1Q192R phenotype, is a predictor of coronary artery disease in a middle-aged Serbian population
- A modified method of prothrombin time/International Normalised Ratio determination in capillary blood and monitoring oral anticoagulant therapy
- Inhibition of the ubiquitin-proteasome system: a new avenue for atherosclerosis
- Lipid peroxidation and antioxidative status in β-thalassemia major patients with or without hepatitis C virus infection
- Role of serum S100B as a predictive marker of fatal outcome following isolated severe head injury or multitrauma in males
- Preanalytical and analytical variation of surface-enhanced laser desorption-ionization time-of-flight mass spectrometry of human serum
- Effect of nitrogen mustard, a vesicant agent, on lymphocyte energy metabolism
- Partitioning reference values of several Gaussian subpopulations with unequal prevalence – a procedure with computer program support
- Biovariability of plasma adiponectin
- Multicentre evaluation of a new point-of-care test for the determination of NT-proBNP in whole blood
- Innotrac Aio!: a point-of-care or a routine analyzer? Analytical performance and plasma/whole blood comparison
- Serologic associations of anti-cytoplasmic antibodies identified during anti-nuclear antibody testing
- The importance of metrological traceability on the validity of creatinine measurement as an index of renal function: International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)
- Effect of seropositive rheumatoid factor on cardiac troponin I measurement using the Access® Immunoassay Analyzer
Articles in the same Issue
- Multiplexed testing in the autoimmunity laboratory
- Uncertainty calculation for calibrators and controls of laboratory diagnostic assays
- Westgard multirule for calculated laboratory tests
- Frequency of a single nucleotide (A2317G) and 56-bp variable number of tandem repeat polymorphisms within the deoxyribonuclease I gene in five ethnic populations
- The influence of genetic polymorphisms of cytochrome P450 3A5 and ABCB1 on starting dose- and weight-standardized tacrolimus trough concentrations after kidney transplantation in relation to renal function
- Apolipoprotein B gene 3′VNTR polymorphism: association with plasma lipids and coronary heart disease in Han Chinese
- Paraoxonase-1 (PON1) activity, but not PON1Q192R phenotype, is a predictor of coronary artery disease in a middle-aged Serbian population
- A modified method of prothrombin time/International Normalised Ratio determination in capillary blood and monitoring oral anticoagulant therapy
- Inhibition of the ubiquitin-proteasome system: a new avenue for atherosclerosis
- Lipid peroxidation and antioxidative status in β-thalassemia major patients with or without hepatitis C virus infection
- Role of serum S100B as a predictive marker of fatal outcome following isolated severe head injury or multitrauma in males
- Preanalytical and analytical variation of surface-enhanced laser desorption-ionization time-of-flight mass spectrometry of human serum
- Effect of nitrogen mustard, a vesicant agent, on lymphocyte energy metabolism
- Partitioning reference values of several Gaussian subpopulations with unequal prevalence – a procedure with computer program support
- Biovariability of plasma adiponectin
- Multicentre evaluation of a new point-of-care test for the determination of NT-proBNP in whole blood
- Innotrac Aio!: a point-of-care or a routine analyzer? Analytical performance and plasma/whole blood comparison
- Serologic associations of anti-cytoplasmic antibodies identified during anti-nuclear antibody testing
- The importance of metrological traceability on the validity of creatinine measurement as an index of renal function: International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)
- Effect of seropositive rheumatoid factor on cardiac troponin I measurement using the Access® Immunoassay Analyzer
