A "Step-Up" approach for harmonization

Clinica Chimica Acta

Volumn 432, Issue , 2014, Pages 62-67

  Van Uytfanghe, Katleen ^a   De Grande, Linde A ^a   Thienpont, Linda M ^a  

^a GHENT UNIVERSITY   (Belgium)

Author keywords

Commutable samples; Complex analytes; Harmonization; Method comparison study; Statistical derived target

Indexed keywords

ANALYTIC METHOD; ARTICLE; ASSAY; DATA PROCESSING; HEALTH CARE ORGANIZATION; INTERMETHOD COMPARISON; INTERNATIONAL STANDARD UNIT; PRIORITY JOURNAL; STANDARDIZATION; STEP UP METHOD; DIAGNOSTIC PROCEDURE; HEALTH CARE QUALITY; HUMAN; INTERPERSONAL COMMUNICATION; RESEARCH; STANDARD; STANDARDS; STATISTICAL ANALYSIS;

CLINICAL LABORATORY TECHNIQUES; COMMUNICATION; DATA INTERPRETATION, STATISTICAL; HUMANS; QUALITY ASSURANCE, HEALTH CARE; REFERENCE STANDARDS; RESEARCH REPORT;

EID: 84901592531     PISSN: 00098981     EISSN: 18733492     Source Type: Journal    
DOI: 10.1016/j.cca.2013.12.015     Document Type: Article

References (18)

1. Vesper H.W., Thienpont L.M. Traceability in laboratory medicine. Clin Chem 2009, 55:1067-1075.
2. ISO 17511:2003 In vitro diagnostic medical devices-measurement of quantities in biological samples-metrological traceability of values assigned to calibrators and control materials 2003, International Organization for Standardization, Geneva.
3. Thienpont L.M. Accuracy in clinical chemistry - who will kiss Sleeping Beauty awake?. Clin Chem Lab Med 2008, 46:1220-1222.
4. Thienpont L.M., Van Houcke S.K. Traceability to a common standard for protein measurements by immunoassay for in-vitro diagnostic purposes. Clin Chim Acta 2010, 411:2058-2061.
5. Miller G.W., Myers G.L., Gantzer L.M., et al. Roadmap for harmonization of clinical laboratory measurement procedures. Clin Chem 2011, 57:1108-1117.
6. Rymer J.C., Sabatier R., Daver A., 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, 45:869-881.
7. Lawton W.H., Sylvestre E.A., Young-Ferraro B.J. Statistical comparison of multiple analytic procedures - application to clinical-chemistry. Technometrics 1979, 21:397-409.
8. Carey R.N., Wold S., Westgard J.O. Principal component analysis: an alternative to "referee" methods in method comparison studies. Anal Chem 1975, 47:1824-1829.
9. Van Houcke S.K., Van Aelst S., Van Uytfanghe K., Thienpont L.M. Harmonization of immunoassays to the all-procedure trimmed mean - proof of concept by use of data from the insulin standardization project. Clin Chem Lab Med 2012, 12:1-3.
10. Van Houcke S.K., Thienpont L.M. "Good samples make good assays" - the problem of sourcing clinical samples for a standardization project. Clin Chem Lab Med 2012, 6:1-6.
11. Thienpont L.M., Van Uytfanghe K., Beastall G., et al. IFCC Working Group on Standardization of Thyroid Function Tests, Report of the IFCC Working Group for Standardization of Thyroid Function Tests; part 1: thyroid-stimulating hormone. Clin Chem 2010, 56:902-911.
12. Thienpont L.M., Van Uytfanghe K., Van Houcke S. IFCC Working Group for Standardization of Thyroid Function Tests (WG-STFT), Standardization activities in the field of thyroid function tests: a status report. Clin Chem Lab Med 2010, 48:1577-1583.
13. Stöckl D., Van Houcke S.K., Van Aelst S., Van Uytfanghe K., Thienpont L.M. A statistical basis for harmonization of thyroid stimulating hormone assays using a robust factor analysis method. AACC 2013 annual meeting, poster A-322 2013, [http://www.aacc.org/events/Annual_Meeting/abstracts/Documents/AACC_13_AM_A279-A363.pdf, page 16, last visited August 2013. Full paper accepted in Clin Chem Lab Med.].
14. CLSI. Preparation and validation of commutable frozen human serum pools as secondary reference materials for cholesterol measurement procedures; approved guideline. CLSI document C37-A, CLSI 1999.
15. CLSI Method comparison and bias estimation using patient samples; approved guideline. CLSI document EP09-A2-IR, CLSI 2010.
16. CLSI Evaluation of precision performance of quantitative measurement methods; approved guideline. CLSI document EP05-A2, CLSI 2004.
17. Donadio S., Pascual A., Thijssen J.H., Ronin C. Feasibility study of new calibrators for thyroid-stimulating hormone (TSH) immunoprocedures based on remodeling of recombinant TSH to mimic glycoforms circulating in patients with thyroid disorders. Clin Chem 2006, 52:286-297.
18. Donadio S., Morelle W., Pascual A., Romi-Lebrun R., Michalski J.C., Ronin C. Both core and terminal glycosylation alter epitope expression in thyrotropin and introduce discordances in hormone measurements. Clin Chem Lab Med 2005, 43:519-530.