The AOAC Official Methods Board (OMB) has recently approved the Biological Threat Agent Method (BTAM) Validation Guideline, a comprehensive technical guidance for conducting AOAC validation studies for biological threat agent methods and/or procedures submitted for Performance Tested Methods^SM (PTM) and Official Methods of Analysis^SM (OMA) status. The guideline introduces an innovative and alternative approach to traditional AOAC method validation, involving a minimum of three laboratories and 12 analysts or independent teams of analysts.

“Approval of the BTAM Guideline is monumental because Committee L [AOAC Methods Committee on Biological Threat Agents] and the OMB struggled with the number of laboratories,” said Deborah McKenzie, senior director of method development and approval processes. “The alternative approach [using a minimum of three laboratories, with four teams per site for a total of 12 collaborators] differs from traditional validation studies which require acceptable data from 8 to 10 collaborating [individual] laboratories.”

In executing contracts for the Department of Homeland Security and Department of Defense for the evaluation and validation of biological threat agent detection methods, AOAC learned that new alternative approaches to assay validation must be considered that are consistent with the challenges and expense associated with select agents, while maintaining the integrity of AOAC’s validation systems. The goal is to provide an efficient, rational, and affordable enduring national capacity for the development, evaluation, validation, and deployment of biological threat agent detection methodology.

The BTAM Guideline is a culmination of input from a wide group of community leaders and volunteers, including the Methods Committees on Microbiology, Biological Threat Agents, and Antimicrobial Efficacy Testing; OMB; AOAC Board of Directors; AOAC Research Institute Board of Directors; biological threat agent method community at large, including first responders and other end-users; method developers and organizations that provide test kits, reagents, and equipment; members of the Stakeholder Panel on Agent Detection Assays (SPADA); and representatives from federal, state, and other government agencies.

The BTAM Guideline describes minimum method performance and validation requirements for method developer (internal), independent, and collaborative studies, and defines steps involved in the validation process for qualitative and quantitative methods, including study design for single-site validations, study design for a collaborative study, and minimum number of test sites and valid data sets for a collaborative study. The guideline also addresses the acceptable minimum detection level (AMDL) for qualitative methods, the acceptable minimum quantitation level (AMQL) for quantitative methods, inclusivity/exclusivity testing (including selection of target and non-target variants), matrix studies, robustness, product consistency and stability, between-instrument variation, and intercollaborator reproducibility. In addition, the guideline covers terms and definitions associated with the PTM and OMA biological threat agent programs.

For more information, contact Deborah McKenzie, Senior Director Methods Development and Approval Processes, at dmckenzie@aoac.org or Scott Coates, Chief Scientific Officer, Microbiology, and Senior Managing Director, AOAC Research Institute, at scoates@aoac.org.

Full coverage is scheduled for the January/February issue of Inside Laboratory Management.

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