Eight compact analysis systems evaluated for measuring total cholesterol

Abstract

We examined the analytical performance of eight compact systems for measuring total cholesterol: AccuMeter, Cobas Ready, Discovery f2, DT60, L-D-X, Reflotron, QCA, and Vision. We determined average bias at two decision levels, the mean absolute bias, and the percentage of results differing from the comparison method results by > 8.9% allowable total error limit for multiple reagent lots. Average bias was < 3% for all lots tested for AccuMeter, Discovery f2, and DT60, but > 3% for one or more lots or sample types tested with the other systems. Of results from each reagent lot, > 95% were within the 8.9% total error specifications with Discovery f2, DT60, and QCA, whereas the performance of L-D-X, Vision, and Reflotron depended on reagent lot and (or) sample type. Of all results from each lot tested with AccuMeter and Cobas Ready, > 5% exceeded the total allowable error limit. We determined imprecision for five systems: Cobas Ready, Discovery f2, and QCA had CVs < 3%, whereas CVs for AccuMeter and L-D-X were > 3% but < 5%.