Commutability assessment of potential reference materials using a multicenter split-patient-sample between-field-methods (twin-study) design: study within the framework of the Dutch project "Calibration 2000".
Publication year
2002Source
Clinical Chemistry, 48, 9, (2002), pp. 1520-1525ISSN
Publication type
Article / Letter to editor

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Organization
Clinical Chemistry
Tumorimmunology
Journal title
Clinical Chemistry
Volume
vol. 48
Issue
iss. 9
Page start
p. 1520
Page end
p. 1525
Subject
Innovation and Quality assurance in laboratory medicine; Ontwikkeling en kwaliteitsborging in de laboratoriumgeneeskundeAbstract
BACKGROUND: The Dutch project "Calibration 2000" aims at harmonization of laboratory results via calibration by development of commutable, matrix-based, secondary reference materials. An alternative approach to the NCCLS EP14 protocol for studying commutability of reference materials is presented, the "twin-study design", which in essence is a multicenter, split-patient-sample, between-field-methods protocol. METHODS: The study consisted of the simultaneous analysis of fresh patient sera and potential reference materials (PRMs) for HDL-cholesterol (HDL-C) by 86 laboratories forming 43 laboratory couples. Six subgroups of method combinations were formed. The patient sera were selected and interchanged by each laboratory couple. The PRMs consisted of three types: C37, prepared according to the NCCLS C37 protocol; Fro, frozen selectively pooled human serum; and Lyo, which was the same serum pool as Fro but lyophilized in the presence of sucrose. All PRMs were provided in three HDL-C concentrations. The regression line residuals for the PRMs were normalized by expressing them as multiples of the state-of-the-art within laboratory SD (SD(SA)). In addition, the extra contribution of each PRM to the total measurement uncertainty, CV(Netto), was calculated. RESULTS: Averaged over the three PRM concentrations, 1.6% of the C37 residuals were outside the 3 SD(SA) limit. For the Fro and Lyo PRMs, these values were 2.4% and 11.1%. CV(Netto) values for C37, Fro, and Lyo were 2.9%, 4.3%, and 5.3%, respectively. CONCLUSIONS: The present twin-study design, as a practical alternative to the NCCLS EP14 protocol, is a viable way of studying commutability characteristics of PRMs. The study suggests that the C37 PRMs are the best candidates for a future reference material.
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- Academic publications [205104]
- Faculty of Medical Sciences [81055]
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