title: Improved performance of ELISAs for fertility assessment using common reagents and assay protocol as evidence from quality control studies.
abstract: 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.
authors.affiliation: Department of Immunodiagnostics (ELISA), Institute for Research in Reproduction (ICMR), Parel, Mumbai, India.
authors.forename: Meena P
authors.initials: MP
authors.lastname: Desai
authors.forename: Uday M
authors.initials: UM
authors.lastname: Donde
authors.forename: M Ikram
authors.initials: MI
authors.lastname: Khatkhatay
mesh_terms: D000704:Analysis of Variance; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods* / Q000592:standards; D004970:Estrone / Q000031:analogs & derivatives / Q000652:urine*; D005298:Fertility; D005640:Follicle Stimulating Hormone / Q000652:urine*; D005965:Glucuronates / Q000737:chemistry / Q000652:urine; D006801:Humans; D007118:Immunoassay / Q000379:methods; D007986:Luteinizing Hormone / Q000652:urine*; D011276:Pregnanediol / Q000031:analogs & derivatives / Q000652:urine*; D011485:Protein Binding; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012189:Retrospective Studies; D012680:Sensitivity and Specificity
chemical_list: D005965:Glucuronates; D011933:Reagent Kits, Diagnostic; D004970:Estrone; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone; D011276:Pregnanediol