Abstract
We evaluated the new VITROS direct high density lipoprotein cholesterol (dHDL) slide assay, based on the precipitation of apolipoprotein B-containing lipoproteins by phosphotungstic acid/magnesium chloride (PTA/MgCl2). We determined linearity, within-run and between-run imprecision for the VITROS dHDL slide assay, and compared it to the RANDOX two-step PTA/MgCl2 method for 300 fresh sera. Moreover, triglyceride and cholesterol interference were tested. The VITROS dHDL slide assay was linear from 0 to 3.13 mmol/l. Within-run and between-run imprecision were 1.6%, 1.8%, 3.3% and 3.2% for target values at 1.00 and 1.40 mmol/l, respectively. For 300 fresh serum samples, the linear regression equation between the VITROS dHDL slide assay (y) and the RANDOX PTA/MgCl2 2 method (x) was: y (mmol/l)=0.934 x+0.043 (CI=0.916-0.952 for slope and 0.017-0.069 for intercept) . The bias of the VITROS assay compared to the RANDOX PTA/MgCl2 method was less than 5% for HDL cholesterol concentrations used for medical decision (1.04 and 1.50 mmol/l). Total error remained below 13% for triglyceride and LDL cholesterol concentrations below 6.6 mmol/l. The VITROS dHDL slide assay is rapid, linear over a broad range of concentrations, and satisfies the National Cholesterol Education Program goals for precision and accuracy.
Published Version
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