Metrological traceability of calibration in the estimation and use of common medical decision-making criteria

Clinical Chemistry and Laboratory Medicine

Volumn 42, Issue 7, 2004, Pages 842-850

  Thienpont, Linda M ^a   Van Uytfanghe, Katleen ^a   Cabaleiro, Diego Rodríguez ^a  

^a GHENT UNIVERSITY   (Belgium)

Author keywords

Metrological traceability chain; Reference materials; Reference measurement laboratories; Reference measurement procedures; Reference measurement system; Trueness based standardization

Indexed keywords

ANALYTIC METHOD; ARTICLE; BIOCHEMISTRY; BLOOD ANALYSIS; BLOOD CHEMISTRY; CALIBRATION; HUMAN; IMMUNOASSAY; LABORATORY DIAGNOSIS; LABORATORY TEST; LEGAL ASPECT; MEASUREMENT; MEDICAL DECISION MAKING; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; PREDICTION AND FORECASTING; PRIORITY JOURNAL; REFERENCE VALUE; STANDARDIZATION; VALIDATION PROCESS;

CALIBRATION; DECISION SUPPORT TECHNIQUES; DIAGNOSTIC TECHNIQUES AND PROCEDURES; EQUIPMENT AND SUPPLIES; EQUIPMENT FAILURE ANALYSIS; REFERENCE STANDARDS;

EID: 4344681290     PISSN: 14346621     EISSN: None     Source Type: Journal    
DOI: 10.1515/CCLM.2004.138     Document Type: Article

References (46)

1. Pyorala K, De Backer G, Graham I, Poole-Wilson P, Wood D. Prevention of coronary heart disease in clinical practice. Recommendations of the Task Force of the European Society of Cardiology, European Atherosclerosis Society and European Society of Hypertension. Eur Heart J 1994;15:1300-31.
2. National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation 2002; 106:3143-421.
3. Sacks DB, Bruns DE, Goldstein DE, Maclaren NK, McDonald JM, Parrott M. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem 2002;48:436-72.
4. Cali JP. An idea whose time has come. Clin Chem 1973;19:291-3.
5. Tietz NW. A model for a comprehensive measurement system in clinical chemistry. Clin Chem 1979;25:833-9.
6. Müller MM. Implementation of reference systems in laboratory medicine [opinion]. Clin Chem 2000;46:1907-9.
7. McNamara JR, Leary ET, Ceriotti F, Boersma-Cobbaert CM, Cole TG, Hassemer DJ, et al. Point: status of lipid and lipoprotein standardization. Clin Chem 1997; 43:1306-10.
8. Stenman UH. Immunoassay standardization: is it possible, who is responsible, who is capable? Clin Chem 2001;47:815-20.
9. 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):L 331/1-L 331/37.
10. European Diagnostic Manufacturers Association (EDMA) position paper. General concepts of medical and metrological traceability in laboratory medicine, March 2001.
11. BIPM, IEC, IFCC, ISO, IUPAC, IUPAP, OIML. Vocabulaire International des Termes Fondamentaux et Généraux de Métrologie (VIM), 2nd ed. Geneva: ISO, 1993.
12. In Vitro Diagnostic Medical Devices, Measurement of quantities in biological samples, metrological traceability of values assigned to calibrators and control materials, EN/ISO 17511. 2002.
13. In Vitro Diagnostic Medical Devices, Measurement of quantities in samples of biological origin, metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials, EN/ISO 18153.2002.
14. In Vitro Diagnostic Systems, Measurement of Quantities in Samples of Biological Origin, Presentation of Reference Measurement Procedures, ISO 15193 (EN 12286).
15. In Vitro Diagnostic Medical Devices, Measurement of Quantities in Samples of Biological Origin, Description of Reference Materials, ISO 15194 (EN 12287).
16. Laboratory Medicine, Requirements for Reference Measurement Laboratories, EN/ISO 15195.
17. Miller WG, Kaufman HW, McLendon WW, editors. College of American Pathologists Conference XXIII. Matrix effects and accuracy assessment in clinical chemistry. Arch Pathol Lab Med 1993;117:343-436.
18. European Diagnostic Manfacturers Association (EDMA) position paper. Interpretation of the CEN/ISO standards prEN ISO 17511 and prEN ISO 18153 on metrological traceability of values assigned to calibrators and control materials, March 2001.
19. Roche Diagnostics Scandinavia. Realizing the traceability concept. Newsletter, Special Issue February 2003.
20. Dybkaer R. Metrology in laboratory medicine - reference measurement systems. Accred Qual Assur 2001;6:16-9.
21. Thienpont LM, Van Uytfanghe K, De Leenheer AP. Reference measurement systems in clinical chemistry. Clin Chim Acta 2002;323:73-87.
22. Thienpont LM, Franzini C, Kratochvila J, Middle J, Ricós C, Siekmann L, et al. Analytical quality specifications for reference methods and operating specifications for networks of reference laboratories. Recommendations of the European EQA-Organizers Working Group B. Eur J Clin Chem Clin Biochem 1995;33:949-57.
23. Thienpont LMR. Quality specifications for reference methods. Scand J Clin Lab Invest 1999;59:535-8.
24. Stöckl D, Franzini C, Kratochvila J, Middle J, Ricos C, Thienpont LM. Current stage of standardization of measurements of specific polypeptides and proteins discussed in light of steps needed towards a comprehensive measurement system. Eur J Clin Chem Clin Biochem 1997;35:719-32.
25. Rymer JC, Sabatier R, Daver A, Bourleaud J, Assicot M, Bremond J, et al. A new approach for clinical biological assay comparison and standardization: application of principal component analysis to a multicenter study of twenty-one carcinoembryonic antigen immunoassay kits. Clin Chem 1999;45:869-81.
26. Moss DW, Whicher JT. Reference materials and reference measurement systems in laboratory medicine. Commutability and the problem of method-dependent results. Eur J Clin Chem Clin Biochem 1995;33:1003-7.
27. Franzini C. Commutability of reference materials in clinical chemistry. J Int Fed Clin Chem 1993;5:169-73.
28. National Committee of Clinical Laboratory Standards. Evaluation of matrix effects; approved guideline. NCCLS document EP14-A (ISBN 1-56238-434-1). Wayne, PA: NCCLS; 2000.
29. National Committee of Clinical Laboratory Standards. Preparation and validation of commutable frozen human serum pools as secondary reference materials for cholesterol measurement procedures; approved guideline. NCCLS document C37-A (ISBN 1-56238-392-2). Wayne, PA: NCCLS; 2000.
30. Lasky FD. Achieving accuracy for routine clinical chemistry methods by using patient specimen correlations to assign calibrator values. A means of managing matrix effects. Arch Pathol Lab Med 1993;117:412-9.
31. Thienpont LM. A reference system for cortisol. Clin Biochem 1998;31:483-8.
32. Thienpont LMR, De Leenheer AP, Siekmann L, Kristiansen N, Linsinger T, Schimmel H, et al. The characterisation of cortisol concentrations in a serum reference panel (IRMM/IFCC No 451). European Commission, Directorate General, Joint Research Centre, IRMM/IFCC Information, Reference Materials, EUR 19007 EN (1999).
33. International Organization for Standardization. Guide to the expression of uncertainty in measurement (GUM), 1st ed. Geneva: ISO, 1993.
34. EURACHEM/CITAC. Quantifying uncertainty in analytical measurement. EURACHEM/CITAC Guide CG4. Berlin: BAM, 2000.
35. 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.
36. Kristiansen J. The Guide to Expression of Uncertainty in Measurement approach for estimating uncertainty: an appraisal. Clin Chem 2003;49:1822-9.
37. 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;39:589-95.
38. Kristiansen J. Description of a generally applicable model for the evaluation of uncertainty of measurement in clinical chemistry. Clin Chem Lab Med 2001;39:920-31.
39. Stöckl D, Baadenhuijsen H, Fraser CG, Libeer J-C, Hyltoft Petersen P, Ricós C. Desirable routine analytical goals for quantities assayed in serum. Eur J Clin Chem Clin Biochem 1995;33:157-69
40. www.westgard.com/biodatabase1.htm
41. Fraser CG, Kallner A, Kenny D, Petersen PH. Strategies to set global analytical quality specifications in laboratory medicine. Consensus Statement, Stockholm 1999. Scand J Clin Lab Invest 1999;59:585.
42. Bristow AF, Das Re. WHO international reference reagents for human proinsulin and human insulin C-peptide. J Biol Stand 1988;16:179-86.
43. Use of External Quality Assessment Schemes in the Assessment of the Performance of In Vitro Diagnostic Procedures. EN 14136.
44. Thienpont LM, Stöckl D, Kratochvila J, Friedecky B, Budina M. Pilot external quality assessment survey for post-market vigilance of in vitro diagnostic medical devices and investigation of trueness of participants' results. Clin Chem Lab Med 2003;41:183-6.
45. 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;63:195-201.
46. Miller WG. Specimen materials, target values and commutability for external quality assessment (proficiency testing) schemes. Clin Chim Acta 2003;327:25-37.