Analytical and Clinical Performance of an Automated Immunoassay System (Immulite�) for Estradiol in Serum

Abstract

The analytical and clinical performance of a commercial automated immunoassay system (Immulite) for estradiol (E2) in serum was evaluated. The functional sensitivity for E2 was 0.07 nmol/l, and analytical imprecision (<13%, <9% and <7% at 0.22, 0.51 and 1.51 nmol/l, respectively) for concentrations above this detection limit met published analytical goals. The assay recovery was good and the assay was linear over a wide concentration range. No sample carryover was found, and interferences from common substances present in serum were observed only at very high concentrations. Most of samples from men and postmenopausal women showed E2 concentrations below the detection limit. Longitudinal estradiol profiles from 11 healthy menstruating women showed characteristic menstrual cycle patterns (12 samples per subject obtained during a 30-day period). Longitudinal studies on women during induction of ovulation showed that E2 concentrations are highly correlated with the total number of follicles. Our results demonstrate the reliability of this system for routine use in the clinical laboratory.

Collagen remodelling in the guinea-pig uterine cervix at term is associated with a decrease in progesterone receptor expression

“…Results were recorded with the Immulite Analyzer. Quality control of the assays was performed according to the manufacturer's instructions, as well as previously published results (Costongs et al, 1995;Rodriguez-Espinosa et al, 1998). Cross-reactivity for both antisera (against progesterone and E 2 ) were evaluated by the manufacturer and found to be <1.5%.…”

Performance Characteristics of Eight Estradiol Immunoassays

“…While these systems provide rapid turnaround times and high throughput, there presently are only limited reports regarding the analytic performance of these assays, and most do not assess accuracy with ID-GC-MS as the reference method. [5][6][7][8] The aim of our study was to assess the imprecision and accuracy of 8 automated estradiol assays with ID-GC-MS as the reference method.…”