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Clinical Chemistry 48: 1520-1525, 2002;
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(Clinical Chemistry. 2002;48:1520-1525.)
© 2002 American Association for Clinical Chemistry, Inc.

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"

Henk Baadenhuijsen1a, Herman Steigstra1, Christa Cobbaert2,3, Aldy Kuypers1, Cas Weykamp4 and Rob Jansen5

1 Dutch Foundation for Quality Assessment in Clinical Laboratories (SKZL), University Hospital Nijmegen, NL 6500 HB Nijmegen, The Netherlands.

2 Amphia Hospital, 4819 EV Breda, The Netherlands.

3 Lipid Reference Laboratory, University Hospital Rotterdam, 3000 CA Rotterdam, The Netherlands.

4 Queen Beatrix Hospital, 7100 GG Winterswijk, The Netherlands.

5 St. Anna Hospital, 5660 AB Geldrop, The Netherlands.

aAddress correspondence to this author at: University Medical Center Nijmegen, Department of Clinical Chemistry/116 SKZL, PO Box 9101, NL 6500 HB Nijmegen, The Netherlands. Fax 31-24-356-0686; e-mail hbaadenhuijsen{at}skzl.nl.

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 (SDSA). In addition, the extra contribution of each PRM to the total measurement uncertainty, CVNetto, was calculated.

Results: Averaged over the three PRM concentrations, 1.6% of the C37 residuals were outside the 3 SDSA limit. For the Fro and Lyo PRMs, these values were 2.4% and 11.1%. CVNetto 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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