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'
| Autor: | Christa M. Cobbaert, Rob Jansen, H. Baadenhuijsen, Cas Weykamp, Aldy Kuypers, Herman Steigstra |
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| Rok vydání: | 2002 |
| Předmět: |
Protocol (science)
Serum pool Blood Specimen Collection Calibration (statistics) Sample (material) Biochemistry (medical) Clinical Biochemistry Cholesterol HDL Total measurement Ontwikkeling en kwaliteitsborging in de laboratoriumgeneeskunde Reference Standards Laboratory results Innovation and Quality assurance in laboratory medicine Field methods Statistics Design study Humans Algorithms Mathematics Netherlands |
| Zdroj: | Clinical Chemistry, 48, 1520-5 Scopus-Elsevier Clinical Chemistry, 48, 9, pp. 1520-5 Europe PubMed Central |
| ISSN: | 0009-9147 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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