Analytical evaluation of the testosterone assay on the Bayer Immuno 1 system.

Abstract:

OBJECTIVES:To evaluate the analytical performance of the testosterone assay performed on the Bayer immuno 1 system from Bayer Corporation. DESIGN AND 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.

journal_name

Clin Biochem

journal_title

Clinical biochemistry

authors

Lévesque A,Letellier M,Swirski C,Lee C,Grant A

doi

10.1016/s0009-9120(97)00140-9

subject

Has Abstract

pub_date

1998-02-01 00:00:00

pages

23-8

issue

1

eissn

0009-9120

issn

1873-2933

pii

S0009912097001409

journal_volume

31

pub_type

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