Improved performance of ELISAs for fertility assessment using common reagents and assay protocol as evidence from quality control studies.

At our Institute, a panel of reproductive hormones, viz., estrone glucuronide (E1G), pregnanediol glucuronide (PdG), luteinising hormone (LH), and follicle stimulating hormone (FSH) are estimated by ELISA for the assessment of fertility from a single urine sample collected from a subject. In order to make the estimates less cumbersome, the selection and mode of presentation of immunoreagents of the assay were modified in such a way that, either on reconstitution or single dilution, would result in ready-to-use reagents in the assay. Retrospective analysis on the performance of these ELISAs with uniform protocols (n = 86) was compared with assays having individual assay protocols (n = 116). The performance of the assay, based on the standard curve characteristics and quality control pools, was better and the rate of acceptance of these assays improved from 87.9 to 97.6%. The simplification of assay protocols, thus, had better impact on the quality and reproducibility of immunoassay of the four analytes.