Analytical evaluation of the testosterone assay on the Bayer Immuno 1 system.
OBJECTIVE
To evaluate the analytical performance of the testosterone assay performed on the Bayer immuno 1 system from Bayer Corporation.


METHODS
The precision was measured using three Bayer TESTpoint Ligand controls, three Medical Decision Pools and the Bayer SETpoint Testosterone calibrators. The linearity was verified by diluting two serum samples containing high testosterone concentrations with the zero calibrator and the minimum detectable concentration determined by repetitive analysis of the zero calibrator. The assay was correlated with the Diagnostic Products Corporation (DPC) Total Testosterone assay using 342 serum samples. The reference values were determined 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 varying 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 Bayer Immuno 1 and the DPC assays was observed with different categories of serum samples (Immuno 1 = 1.11 x DPC-0.32, r = 0.989, Sy[symbol: see text]x = 2.07 nmol/L). The reference values were estimated at 0.3-3.2 nmol/L for females and 9.3-35.6 nmol/L for males.


CONCLUSIONS
The Bayer Immuno 1 Testosterone assay demonstrates the analytical characteristics required for its utilization in the clinical laboratory.
Lévesque
A
A
Centre for Research and Evaluation in Immunodiagnostics, Centre Universitaire de Santé de l'Estrie, Site Fleurimont, Sherbrooke, Québec, Canada.
Letellier
M
M
Swirski
C
C
Lee
C
C
Grant
A
A
D000328:Adult; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods / Q000592:standards*; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011863:Radioimmunoassay / Q000379:methods / Q000592:standards; D011933:Reagent Kits, Diagnostic; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013223:Statistics as Topic; D013739:Testosterone / Q000097:blood*
D011933:Reagent Kits, Diagnostic; D013739:Testosterone