The first international standard for human leptin and the first international standard for mouse leptin: comparison of candidate preparations by in vitro bioassays and immunoassays.

In an international collaborative study, two preparations of human sequence recombinant leptin and two preparations of mouse sequence recombinant leptin were evaluated, using in vitro bioassays and immunoassays, by eight laboratories, in three countries, for their suitability to serve as the international standard (IS) for human and mouse leptin respectively. The bioassays detected the human and mouse leptin with similar potency, while the immunoassays showed a greater response to the leptin of the species against which the antibody preparation had been raised. Comparison of the candidate standards with the various preparations of leptin of the same species currently assayed in the participating laboratories showed that immunoassay measurements cannot be used to predict the biological potency. On the basis of the results reported here, in October 1999 the Expert Committee on Biological Standardization of the World Health Organization established the preparation coded 97/594 as the first IS for human leptin, with an assigned unitage of 4000 IU/ampoule, and the preparation coded 97/626 as the first IS for mouse leptin, with an assigned unitage of 4000 IU/ampoule. The ISs for leptin are distributed by the National Institute for Biological Standards and Control, UK, http://www.nibsc.ac.uk.