ANALYTICAL PERFORMANCE OF BAYER IMMUNE I(TM) ESTRADIOL AND PROGESTERONE ASSAYS

We evaluated the analytical performance of new estradiol and progester one assays performed on the Payer Immune 1(TM) system. Within-run and between-day CVs for estradiol at concentrations of 116.8-6645.8 pmol/L were less than or equal to 6.4% and for 5.54-103.95 nmol/L progestero ne were less than or equal to 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 pr ogesterone (n = 47 over 20 days). The assays were linear to 9766 pmol/ L and 113.0 nmol/L, respectively. Estradiol results agreed well with t he Diagnostic Products Corporation (DPC) assays, except for serum samp les from patients receiving estrogen replacement therapy; results for these samples agreed closely with the DPC estradiol-6 assay. The proge sterone assay agreed closely with the DPC assay, except for samples fr om 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 laborator y.