Medical Research and Evaluation Facility (MREF) and Studies Supporting theMedical Chemical Defense Program: Task 95-39: Methods Development and Validation of Two Mouse Bioassays for Use in Quantifying Botulinum Toxins (A, B, C, D and E) and Toxin Antibody

摘要

Ths task was conducted for the U.S. Army Medical Materiel Development Activity(USAMMDA) to validate two mouse bioassays for quantify botulinum toxin potency and neutralizing antibodies to botulimun toxins. Phase I experiments were designed to validate the mouse potency assay. The coefficients of variation for day-to-day variability were 10, 7, 10, 9 and 13 percent for serotypes A, B, C, D, and E, respectively. Phase II experiments were -brined to develop and validate an assay for measuring neutralizing antibody content of serum. Avidity reetits were characterized at three separate test levels, L+/10, L+/33, and L+/100. The coefficients of variation for day-to-day variability were 9, 44, 11, 34, and 13 percent for serotype A, B, C, D, and E, respectively. Limits of intitation were approximately 0.02, 0.005, 0.012, 0.026, and 0.013 U/mL for serotypes A, B, C, D, and B, respectively. Phase III consisted of limited studies to develop a model of passive immunity in guinea pigs by intraperitoneal treatment with human botulinum immune globulin (BIG).