Search

Aprototype kit for the detection of occurrence of ovulation based on urinary pregnanediol glucuronide estimations by ELISA was developed in our laboratory. This kit was sent for evaluation at 4 centres in Bombay and Pune, India. The diagnosis of ovulation/anovulation based on the results of the kit is comparable with that based on reference parameters commonly used (ultrasonography of ovarian follicles and serum progesterone estimations). The accuracy of the test was 93.5%, specificity was 87.5% and sensitivity was 95.7%. This rapid indigenous test can be very useful in assessing ovulatory status of the woman by the clinicians in their offices.

Penicillinase (beta-lactamase) enzyme-linked immunosorbent assay (ELISA) for various reproductive hormones developed in the laboratory were found to have wide applicability in the fertility check clinic of the Institute. A need was thought to transform these assays into ready-to-use kit forms. Therefore, prototype ELISA kits for these hormones were developed and stability of the individual component was ascertained at various temperatures (room temperature, 37 degrees C and 2-8 degrees C). Stability studies were conducted on previously validated assay for pregnanediol-3 alpha-glucuronide (PdG). The studies showed that immunosorbents (antibody coated plates) are stable at room temperature for a period of 2 weeks, at 37 degrees C for 1 week and at 2-8 degrees C for a period of 9 months when preserved after treatment with glycerol solution. The lyophilised conjugate, standard and immunoassay buffer, colour reagent, and its substrate were stable at 37 degrees C up to 1 week and at room temperature up to 2 weeks and at 2-8 degrees C for a period of 6 months, during which the stability was studied.