Application of traceability concepts to analytical quality control may reconcile total error with uncertainty of measurement

Clinical Chemistry and Laboratory Medicine

Volumn 48, Issue 1, 2010, Pages 7-10

  Panteghini, Mauro ^a  

^a UNIVERSITY OF MILAN   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ACCREDITATION; CALIBRATION; CLINICAL LABORATORY; CLINICAL PRACTICE; EDITORIAL; ERROR; LABORATORY TEST; MEDICAL SOCIETY; PERFORMANCE; PRIORITY JOURNAL; QUALITY CONTROL; RELIABILITY;

CLINICAL LABORATORY TECHNIQUES; DIAGNOSTIC ERRORS; QUALITY CONTROL; UNCERTAINTY;

EID: 74549137312     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/CCLM.2010.020     Document Type: Editorial

References (33)

1. Westgard JO. Managing quality vs. measuring uncertainty in the medical laboratory. Clin Chem Lab Med 2010;48:31-40.
2. Dybkaer R. From total allowable error via metrological traceability to uncertainty of measurement of the unbiased result. Accred Qual Assur 1999;4:401-405
3. Dybkaer R. Setting quality specifications for the future with newer approaches to defining uncertainty in laboratory medicine. Scand J Clin Lab Invest 1999;59:579-584
4. ISO 15189:2007. Medical laboratories-Particular requirements for quality and competence. ISO, Geneva, Switzerland.
5. JCGM 100:2008. Evaluation of measurement data-Guide to the expression of uncertainty in measurement. 1st ed. September 2008.
6. Linsinger TP, Pauwels J, Schimmel H, Lamberty A, van der Veen AM, Schumann G, et al. Estimation of the uncertainty of CRMs in accordance with GUM: application to the certification of four enzyme CRMs. Fresenius J Anal Chem 2000;368:589-594
7. Siekmann L. Requirements for reference (calibration) laboratories in laboratory medicine. Clin Biochem Rev 2007;28:149-154
8. Klauke R, Schumann G. Uncertainty sources of reference measurement procedures for enzymes. 2nd International Scientific Meeting "Standardization in clinical enzymology: a challenge for the theory of metrological traceability". November 25, 2008, Milano, Italy. Available at: http://users.unimi.it/cirme/ public/UploadAttach/2-Schumann-new.pdf. Accessed on October 20, 2009.
9. Krouwer JS. Point. Critique of the Guide to Expression of Uncertainty in Measurement method of estimating and reporting uncertainty in diagnostic assays. Clin Chem 2003;49:1818-1821
10. Kristiansen J. Countepoint. The Guide to Expression of Uncertainty in Measurement approach for estimating uncertainty: an appraisal. Clin Chem 2003;49:1822-1829
11. Kristiansen J, Christensen JM. Traceability and uncertainty in analytical measurements. Ann Clin Biochem 1998;35:371-379
12. Linko S, Ö rnemark U, Kessel R, Taylor PD. Evaluation of uncertainty of measurement in routine clinical chemistry-Application to determination of the substrate concentration of calcium and glucose in serum. Clin Chem Lab Med 2002; 40:391-398
13. Panteghini M. Traceability as a unique tool to improve standardization in laboratory medicine. Clin Biochem 2009;42: 236-240
14. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on In Vitro Diagnostic Medical Devices. Official Journal of the European Communities 1998 (Dec 7);L331:1-37.
15. ISO 17511:2003. In vitro diagnostic medical devices-Measurement of quantities in biological samples-Metrological traceability of values assigned to calibrators and control materials. ISO, Geneva, Switzerland.
16. ISO 18153:2003. In vitro diagnostic medical devices-Measurement of quantities in biological samples-Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials. ISO, Geneva, Switzerland.
17. Dati F. The new European Directive on in vitro diagnostics. Clin Chem Lab Med 2003;41:1289-1298
18. White GH. Basics of estimating measurement uncertainty. Clin Biochem Rev 2008;29(Suppl):S53-60.
19. NCCLS. Estimation of total analytical error for clinical laboratory methods; approved guideline. NCCLS document EP21- A. Wayne, PA: NCCLS, 2003.
20. Kallner A, Waldenström J. Does the uncertainty of commonly performed glucose measurements allow identification of individuals at high risk for diabetes? Clin Chem Lab Med 1999; 37:907-912
21. Stöckl D, Reinauer H. Development of criteria for the evaluation of reference method values. Scan J Clin Lab Invest 1993; 53(Suppl 212):16-18
22. http://www.bipm.org/en/committees/jc/jctlm/jctlm-wg2/. Accessed on October 22, 2009.
23. Guerra E, Carobene A, Ferrero CA, Ceriotti F. Calcolo dell'incertezza per la determinazione dell'attività catalitica della gamma- GT: confronto fra tre approcci. Biochim Clin 2009;33:507.
24. Miller WG. Specimen materials, target values and commutability for external quality assessment (proficiency testing) schemes. Clin Chim Acta 2003;327:25-37.
25. Lasky FD. Proficiency testing linked to the National Reference System for the Clinical Laboratory: a proposal for achieving accuracy. Clin Chem 1992;38:1260-1267
26. Thienpont LM, Stöckl D, Friedecky B, Kratochvila J, Budina M. Trueness verification in European external quality assessment schemes: time to care about the quality of the samples. Scand J Clin Lab Invest 2003;63:195-202.
27. Baadenhuijsen H, Kuypers A, Weykamp K, Cobbaert C, Jansen R. External Quality Assessment in The Netherlands: time to introduce commutable survey specimens. Lessons from the Dutch "Calibration 2000" project. Clin Chem Lab Med 2005; 43:304-307
28. Panteghini M on behalf of the IFCC Scientific Division. Enzymatic assays for creatinine: time for action. Clin Chem Lab Med 2008;46:567-572 (Pubitemid 351820369)
29. Panteghini M. The future of laboratory medicine: understanding the new pressures. Clin Biochem Rev 2004;25:207-215
30. Myers GL, Miller WG, Coresh J, Fleming J, Greenberg N, Greene T, et al. Recommendations for improving serum creatinine measurement: a report from the Laboratory Working Group of the National Kidney Disease Education Program. Clin Chem 2006;52:5-18.
31. Panteghini M. A critical appraisal of experimental factors influencing the definition of the 99th percentile limit of cardiac troponins. Clin Chem Lab Med 2009;47:1179-1182
32. Plebani M. What information on quality specifications should be communicated to clinicians, and how? Clin Chim Acta 2004;346:25-35.
33. Petersen PH, Stöckl D, Westgard JO, Sandberg S, Linnet K, Thienpont L. Models for combining random and systematic errors. Assumptions and consequences for different models. Clin Chem Lab Med 2001;39:589-595