ANALYTICAL EVALUATION OF THE TESTOSTERONE ASSAY ON THE BAYER-IMMUNO-1(TM) SYSTEM

Objectives: To evaluate the analytical performance of the testosterone assay performed on the Bayer Immune 1(TM) system from Bayer Corporati on. Design and Methods: The precision was measured using three sayer T ESTpoint(TM) Ligand controls, three Medical Decision Pools and the Bay er SETpoint(TM) Testosterone calibrators. The linearity was verified b y diluting two serum samples containing high testosterone concentratio ns with the zero calibrator and the minimum delectable concentration d etermined by repetitive analysis of the zero calibrator. The assay was correlated with the Diagnostic Products Corporation (DPC) Total Testo sterone assay using 342 serum samples. The reference values were deter mined using serum samples from 75 women and 60 men. Results: The assay showed within-run coefficients of variation (CVs) varying from 1.1-8. 4% and between-day CVs from 1.5-4.9% for testosterone concentrations v arying from 1.77 to 66.96 nmol/L. The minimum detectable concentration was estimated at 0.11 nmol/L. The assay linearity proved excellent. A good correlation between the sayer Immune 1 and the DPC assays was ob served with different categories of serum samples (Immune 1 = 1.11 x D PC - 0.32, r = 0.989, Sy\x = 2.07 nmol/L). The reference values were e stimated at 0.3-3.2 nmol/L for females and 9.3-35.6 nmol/L for males. Conclusions: The Bayer Immune 1 Testosterone assay demonstrates the an alytical characteristics required for its utilization in the clinical laboratory.