Abstract
Cellulomonas has been shown to be a good source of cholesterol oxidase in addition to Streptomyces for serum cholesterol determination by the endpoint method, inexpensive in cost, and showing excellent performance. For clinical use, we have assessed the reliability of Cellulomonas reagent for cholesterol determination. We constructed the user‐defined endpoint methods on three automated analyzers. The analytical performances (linearity, precision, recovery, interference, stability, and comparison with the standardized method) of Cellulomonas cholesterol reagents were evaluated and compared to those of Streptomyces reagents. Linearity (18.1–23.3 mmol/L) and stability of reagents (6–11 weeks) depended on the analyzers being used. The average within‐run and between‐day % coefficients of variation (CVs) ranged from 1.44 to 2.45 and 1.98 to 2.99, respectively, and were within National Cholesterol Education Program analytical criteria (≤3%). All assays using both reagents compared favorably with the commercial method and appeared accurate near the clinical decision cut‐points. Hemoglobin concentration at 7.5 g/L only affected the assay using single wavelength measurement. Bilirubin decreased in serum cholesterol recovery while lipemia generated a positive interference with all methods. Cellulomonas enzyme is analytically reliable when used for serum cholesterol determination by the endpoint method. Its analytical performance is equivalent to Streptomyces enzymes and meets the analytical goals. It has an advantage over the other enzymes in that it does not ship in the frozen state. J. Clin. Lab. Anal. 22:50–58, 2008.© 2008 Wiley‐Liss, Inc.