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Clinical Chemistry 46: 133-134, 2000;
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(Clinical Chemistry. 2000;46:133-134.)
© 2000 American Association for Clinical Chemistry, Inc.

Letters

Total Error Evaluation of Roche Direct HDL-Cholesterol Reagent and Calibrator across 31 Lot Combinations: A 2-Year Experience

Christa M. Cobbaert1,a

a Address correspondence to this author at: De Baronie Hospital, Department of Clinical Chemistry, Langendijk 75, 4819 EV Breda, The Netherlands. Fax 31-76-5277-043; e-mail cobbaert@worldonline.nl.

Thomas K. J. Luderer2

1 Lipid Reference Laboratory, University Hospital Rotterdam, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands, and, Hospital de Baronie, Department of Clinical Chemistry, Langendijk 75, 4819 EV Breda, The Netherlands

2 Roche Diagnostics Nederland B.V., Markerkant 13-10, 1314 AN Almere, The Netherlands


To the Editor:

Professionally set quality specifications are needed as major considerations in development of new reagents (1). Two years ago, the Dutch Lipid Reference Laboratory, a permanent international member of the CDC Cholesterol Reference Method Laboratory Network (2)(3), in collaboration with Roche Diagnostics Nederland B.V. (formerly Boehringer Almere, The Netherlands), began evaluating lot-to-lot differences of the new direct HDL-cholesterol (HDL-C) reagent from Kyowa Medex (cat. no. 1731157) and of the HDL-C/LDL-cholesterol cfas calibrator (cat. no. 1778501) before distribution on the Dutch market. To this end, a scaled down split-sample comparison protocol was used, essentially according to the design described in the HDL Cholesterol Method Evaluation Protocol for Manufacturers (4)(5). The accuracy platform was the CDC Designated Comparison Method (DCM) for HDL-C (2)(4); . . . [Full Text of this Article]


References




The following articles in journals at HighWire Press have cited this article:


Home page
 Clin. Chem.Home page
C. Cobbaert, C. Weykamp, H. Baadenhuijsen, A. Kuypers, J. Lindemans, and R. Jansen
Selection, Preparation, and Characterization of Commutable Frozen Human Serum Pools as Potential Secondary Reference Materials for Lipid and Apolipoprotein Measurements: Study within the Framework of the Dutch Project "Calibration 2000"
Clin. Chem., September 1, 2002; 48(9): 1526 - 1538.
[Abstract] [Full Text] [PDF]


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