1. A new liquid homogeneous assay for HDL cholesterol determination evaluated in seven laboratories in Europe and the United States.
- Author
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Nauck M, Graziani MS, Jarausch J, Bruton D, Cobbaert C, Cole TG, Colella F, Lefevre F, Gillery P, Haas B, Law T, König M, Macke M, März W, Meier C, Riesen W, van Vliet M, Wieland H, and Rifai N
- Subjects
- Artifacts, Clinical Chemistry Tests standards, Europe, Humans, Laboratories, Reproducibility of Results, Sensitivity and Specificity, United States, Cholesterol, HDL blood, Clinical Chemistry Tests methods
- Abstract
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.
- Published
- 1999
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