Potency evaluation of antivenoms in Brazil: The national control laboratory experience between 2000 and 2006

Envenoming from snakebites is an important public health issue in Brazil. In 2005, 28,597 cases were notified (15 cases/100,000 inhabitants), 87.5% due to Bothrops and 9.2% to Crotalus genus. Antivenoms available in Brazil are liquid preparations containing purified equine Fab′2. Since 1987, the National Institute for Quality Control in Health (INCQS/FIOCRUZ) has been testing all lots prior to batch release. Between 2000 and 2006, 619 lots of antivenoms were tested, comprising 2,513,690 ampoules. The potency assay was performed only for bothropic and crotalic antivenoms (485 lots corresponding to 1,866,726 ampoules) due to the unavailability of the other reference venoms. This paper aims to report the last 7-year activities of INCQS on the quality control, batch release and potency evaluation of antivenoms.