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M. Nauck, M. S. Graziani, J. Jarausch, D. Bruton, C. Cobbaert, T. G. Cole, F. Colella, F. Lefevre, P. Gillery, B. Haas, T. Law, M. König, M. Macke, W. März, C. Meier, W. Riesen, M. van Vliet, H. Wieland, N. Rifai

A New Liquid Homogeneous Assay for HDL Cholesterol Determination Evaluated in Seven Laboratories in Europe and the United States

We evaluated a new liquid homogeneous assay for the direct measurement of high density lipoprotein cholesterol (HDL-C Plus) in seven laboratories. The assay includes two reagents which can be readily used in most available clinical chemistry analyzers.

The total CVs of the new method were below 4.6% and the bias in relation to the designated comparison method was below 3.9%. The total error ranged between 4 to 7%. HDL-C values determined by this method were in good agreement with those obtained by the old homogeneous assay using lyophilized reagents, and other homogeneous and precipitation assays (0.944 < r < 0.996). The assay was linear up to at least 3.89 mmol/l HDL-C.

Hemoglobin did not interfere, whereas in icteric samples slight deviations were observed. Lipemia up to 11.3 to 22.6 mmol/l triglycerides did not interfere with this homogeneous HDL-C assay. In samples of patients with paraproteinemia, discrepant results were seen. This liquid homogeneous HDL-C assay was easy to handle and produced similar results in all laboratories participating in this study. This method will enable clinical laboratories to reliably measure HDL-C for risk assessment of coronary heart disease.

Clinical Chemical Laboratory Medicine, Walter de Gruyter

Print ISSN: 1434-6621
Volume: 37, 11/1999
Pages: 1067 - 1076

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