International collaborative study by in vitro bioassays of the first international standard for porcine inhibin.
A lyophilized preparation of inhibin from porcine ovarian follicular fluid, ampoule code 86/690, was made internationally available as a research standard for in vitro bioassays in 1987. A study involving ten participants in eight countries assessed the stability and suitability of this research standard to serve as an international standard. Each of the participants used in vitro assays, the majority of which depended upon the inhibition of release of follicle-stimulating hormone from dispersed rat anterior pituitary cells. The research standard 86/690 was compared with coded ampoules of 86/690 stored under conditions of accelerated thermal degradation and with inhibins from different species. Intra- and interlaboratory variation for estimates of potency of a coded duplicate ampoule of the research standard provided the basis for comparisons of non-identical inhibins, but the fourfold variability of potency estimates for identical ampoules was such that no conclusions about the differences seen for non-identical inhibins could be made. Predictions of stability from consensus estimates of potency of ampoules that have undergone accelerated thermal degradation indicated that the research standard had satisfactory stability. On the basis of this study, the research standard 86/690 was deemed sufficiently stable and suitable to serve as a standard for in vitro bioassays and was established by the World Health Organization Expert Committee on Biological Standardization as the First International Standard for Porcine Inhibin. The possible presence, in biological extracts (standard or sample), of other bioactive proteins, such as activin and follistatin, complicates the quantitative interpretation of bioassay data. A standard of highly purified human inhibin is now required as a standard for immunoassays used for clinical research purposes; sufficient quantities of recombinant human inhibins have recently been donated for ampouling and evaluation by bio- and immunoassay in the subsequent phase of the standardization of inhibins.
Gaines Das
R E
RE
Division of Informatics, WHO International Laboratory for Biological Standards, National Institute for Biological Standards and Control, Potters Bar, Hertfordshire, UK.
Rose
M
M
Zanelli
J M
JM
D000818:Animals; D001681:Biological Assay / Q000379:methods* / Q000592:standards; D002417:Cattle; D002478:Cells, Cultured; D016009:Chi-Square Distribution; D004305:Dose-Response Relationship, Drug; D004355:Drug Stability; D005260:Female; D005640:Follicle Stimulating Hormone / Q000096:biosynthesis; D015571:Follicular Fluid / Q000737:chemistry; D006801:Humans; D007265:Inhibins / Q000032:analysis* / Q000592:standards; D007391:International Cooperation; D008297:Male; D009924:Organ Culture Techniques; D010902:Pituitary Gland / Q000166:cytology / Q000378:metabolism; D012015:Reference Standards; D015203:Reproducibility of Results; D012756:Sheep; D013552:Swine; D013737:Testis / Q000378:metabolism
D007265:Inhibins; D005640:Follicle Stimulating Hormone