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1 Amphia Hospital, 4819 EV Breda, The Netherlands.
2 Lipid Reference Laboratory, University Hospital Rotterdam, 3000 CA Rotterdam, The Netherlands.
3 Queen Beatrix Hospital, 7100 GG Winterswijk, The Netherlands.
4 Dutch Foundation for Quality Assessment in Clinical Laboratories (SKZL), University Hospital Nijmegen, 6500 HB Nijmegen, The Netherlands.
5 St. Anna Hospital, 5660 AB Geldrop, The Netherlands.
aAddress correspondence to this author at: Amphia Hospital, Langendijk, Department of Clinical Chemistry, Langendijk 75, 4819 EV Breda, The Netherlands. Fax 31-76-5277043; e-mail cobbaert{at}worldonline.nl.
Background: The Dutch project "Calibration 2000" aims at harmonization of laboratory results via calibration by development of matrix-based secondary reference materials. We considered the selection, preparation, and characterization of 34 potential reference materials (PRMs).
Methods: Sixteen PRMs were prepared either strictly according to the NCCLS C37-A protocol or in a less stringent and more convenient way. In addition, 18 commercial, so-called human serum-based calibrators or controls were purchased and tested. Lipoprotein integrity was evaluated by examining the physicochemical characteristics of the materials. Commutability of the PRMs was assessed in 86 Dutch clinical laboratories, using a multicenter split-patient-sample between-field-method (twin-study) design. Normalized residuals of the PRMs with respect to the patient regression lines were calculated; in addition, the extra contribution of each PRM to the total measurement uncertainty (CVNetto) was calculated. On the basis of these results, the most native PRM was selected to investigate its potential to reduce interlaboratory variation and to improve lipid and apolipoprotein standardization.
Results: In general, only the NCCLS C37-A-type materials displayed normalized residuals below the decision limit for commutability and had small CVNetto values ranging between 0 and 3.8%. This contrasts with the findings in regularly pooled frozen sera and lyophilized cryoprotected PRMs. In two subsequent external quality assessment surveys, the NCCLS type C37-A materials contributed to reducing the intermethod lipid and (apo)lipoprotein variation to
24%.
Conclusions: NCCLS C37-A materials have a strong potential as secondary reference materials, not only for cholesterol but also for HDL-cholesterol, LDL-cholesterol, triglyceride, and apolipoprotein measurements.
The following articles in journals at HighWire Press have cited this article:
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H. Baadenhuijsen, H. Steigstra, C. Cobbaert, A. Kuypers, C. Weykamp, and R. Jansen 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" Clin. Chem., September 1, 2002; 48(9): 1520 - 1525. [Abstract] [Full Text] [PDF] |
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