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1
Department of Clinical Chemistry, University Hospital Rotterdam, 3015 GD Rotterdam, The Netherlands.
2
Department of Clinical Chemistry, De Baronie Hospital,
4819 EV Breda, The Netherlands.
3
Department of Epidemiology and Biostatistics, Erasmus
University Rotterdam, 3015 GE Rotterdam, The Netherlands.
Departments of
4
Clinical Chemistry and
5
General Internal Medicine, University Hospital Nijmegen,
6500 HB Nijmegen, The Netherlands.
6
Department of Clinical Chemistry, Queen Beatrix
Hospital, 7101 BN Winterswijk, The Netherlands.
a Address correspondence to this author at: Department of Clinical Chemistry, De Baronie Hospital, Langendijk 75, 4819 EV Breda, The Netherlands. Fax 31 (0)76-5277043; e-mail cobbaert{at}worldonline.nl
Background: Standardization of HDL-cholesterol is needed for risk assessment. We assessed for the first time the accuracy of HDL-cholesterol testing in The Netherlands and evaluated 11 candidate reference materials (CRMs).
Methods: The total error (TE) of HDL-cholesterol measurements was assessed in native human sera by 25 Dutch clinical chemistry laboratories. Concomitantly, the suitability of lyophilized, saccharose-containing CRMs (n = 11) for HDL-cholesterol was evaluated.
Results: In the precipitation method group, which included 25
laboratories and four methods, the mean (minimummaximum) TE was
11.5% (2.725.2%), signifying that 18 of 25 laboratories satisfied
the TE goal of
13% issued by the National Cholesterol Education
Program (NCEP). In the homogeneous HDL-cholesterol method group, which
included five laboratories, each performing two different methods, the
mean (minimummaximum) TE was 9.5% (6.017.3%) for the Boehringer
assay and 15.7% (3.330.7%) for the Genzyme assay. For the
Boehringer homogeneous assay, one of five laboratories did not meet the
TE criterion, whereas for the Genzyme homogeneous assay, three of five
laboratories exceeded the 13% criterion. The biases on the
HDL-cholesterol values found by various precipitation methods were
highly variable in all CRMs, irrespective of the quality, whereas the
biases found by the homogeneous method from Boehringer were far less
than ±5% for the highest-quality CRMs (CRMs 46).
Conclusions: The NCEP goal was met by 24 of 35 laboratories assessed by use of native human sera. Selectively pooled, lyophilized CRMs that are cryoprotected with 200 g/L saccharose have ample potential for use in the standardization of homogeneous HDL-cholesterol methods. © 1999 American Association for Clinical Chemistry
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R. M. Weggemans, P. L. Zock, S. Meyboom, H. Funke, and M. B. Katan Apolipoprotein A4-1/2 polymorphism and response of serum lipids to dietary cholesterol in humans J. Lipid Res., October 1, 2000; 41(10): 1623 - 1628. [Abstract] [Full Text] |
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C. M. Cobbaert and T. K. J. Luderer Total Error Evaluation of Roche Direct HDL-Cholesterol Reagent and Calibrator across 31 Lot Combinations: A 2-Year Experience Clin. Chem., January 1, 2000; 46(1): 133 - 134. [Full Text] [PDF] |
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