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Analytical performance of Bayer Immuno 1^TM estradiol and progesterone assays

¹ Centre for Research and Evaluation in Immunodiagnostics, Department of Clinical Biochemistry, and
² Department of Clinical Biochemistry, Centre universitaire de santé de l'Estrie, Site Fleurimont, 3001, 12^e Ave. Nord, Sherbrooke, QC, Canada J1H 5N4.

³ Bayer Corporation, Business Group Diagnostics, 511 Benedict Ave., Tarrytown, NY 10591-5097.
^a Address correspondence to this author at: Immunova Ltd., 2750 Einstein, Suite 110, Sainte-Foy, QC, Canada G1P 4R1. Fax 418-656-0219.

We evaluated the analytical performance of new estradiol and progesterone assays performed on the Bayer Immuno 1^TMsystem. Within-run and between-day CVs for estradiol at concentrations of 116.8–6645.8 pmol/L were 6.4% and for 5.54–103.95 nmol/L progesterone were 7.7%, thus meeting published analytical goals. The detection limits (2 SDs from mean of zero calibrator) were 27.1 pmol/L for estradiol (n = 72 over 20 days) and 0.51 nmol/L for progesterone (n = 47 over 20 days). The assays were linear to 9766 pmol/L and 113.0 nmol/L, respectively. Estradiol results agreed well with the Diagnostic Products Corporation (DPC) assays, except for serum samples from patients receiving estrogen replacement therapy; results for these samples agreed closely with the DPC estradiol-6 assay. The progesterone assay agreed closely with the DPC assay, except for samples from uremic patients. Reference values were estimated by the study of 29 women throughout the menstrual cycle with 15 samples per subject. We concluded that both assays demonstrate suitable precision, linearity, and intermethod agreement to allow their use in the clinical laboratory.

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