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ICCVAM Biennial Report 2018-2019

Biennial Progress Report 2018-2019 Interagency Coordinating Committee on the Validation of Alternative Methods

Optimization and Validation of an In Vitro Botulinum Neurotoxin Assay

Tests to detect and measure botulinum neurotoxin are required by multiple federal agencies for a variety of purposes, such as measuring toxin in drug formulations or detecting toxin in possibly contaminated food or wildlife. Currently, the standard test for these endpoints is a mouse lethality assay that can use large numbers of animals. NICEATM supports efforts to develop, validate, and implement alternative approaches for tests used to detect the presence of botulinum neurotoxin and measure potency of botulinum neurotoxin preparations.

NICEATM supported the optimization and validation of ELISAs that replace animal-based methods for diagnosing suspected avian botulism samples. Methods were developed for determining the presence or absence of botulinum neurotoxin serotypes C, D, and E in field-collected samples from a wide range of bird species. These methods may be used in the future to support testing requirements for the U.S. Geological Survey’s National Wildlife Health Center.