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Clinical Chemistry 45: 360-370, 1999;
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(Clinical Chemistry. 1999;45:360-370.)
© 1999 American Association for Clinical Chemistry, Inc.


Articles

Survey of Total Error of Precipitation and Homogeneous HDL-Cholesterol Methods and Simultaneous Evaluation of Lyophilized Saccharose-containing Candidate Reference Materials for HDL-Cholesterol

Christa Cobbaert1,2,a, Paul G.H. Mulder3, Henk Baadenhuijsen4, Louwerens Zwang1, Cas W. Weykamp6 and Pierre N.M. Demacker5

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 (minimum–maximum) TE was 11.5% (2.7–25.2%), 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 (minimum–maximum) TE was 9.5% (6.0–17.3%) for the Boehringer assay and 15.7% (3.3–30.7%) 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 4–6).

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




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


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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"
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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.
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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.
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