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AOAC Establishes Alternative and Relevant Collaborative Study Protocol for Threat Detection Methods The AOAC Official Methods Board (OMB) proposed an alternative and relevant collaborative study protocol for threat detection methods, using a minimum of three laboratories and 12 collaborator data sets. The protocol, applicable only to select biological threat agents requiring CDC EA 101 registration, was approved by the Board of Directors at its meeting on April 6-7, 2009 in Gaithersburg, Maryland, USA. The goal is to establish an efficient, rational, and affordable enduring national capacity for the validation of threat agent detection methodology. “Through work with the Department of Defense and Department of Homeland Security, AOAC learned that it is extremely challenging to validate threat detection systems,” said AOAC executive director James Bradford. “We need an affordable and rational way to validate these types of methods that are urgently needed by the biothreat community, without comprising the integrity of the Official MethodsSM process.” In developing the alternative collaborative study protocol, the OMB examined the unique challenges that biological threat agents pose to the standard AOAC collaborative study process. Samples with live agent and/or hazardous organisms cannot be shipped to and from laboratories as is done in the food and agricultural arenas. Special registration is required for shipment of samples containing live agent; and special biosafety laboratories are required for testing. The number of laboratories certified to handle these select agents and available to participate in AOAC validation studies is limited, and the cost to perform testing in such facilities is far beyond the standard AOAC experience and hinders the establishment of an enduring national capacity. Furthermore, the intended use of these methods may be for “field use” by first responders, HAZMAT teams, Civil Support Teams, and other nonlaboratory personnel. Thus, a method validated in the laboratory may require additional data collection in the field to support the method’s applicability, similar to the RAMP Anthrax Test Cartridge Method 2004.08. Details are still being finalized, but in general, the new protocol includes a minimum of three laboratories that have been accredited by a recognized independent body and reviewed by AOAC, at least one unit/platform (instrument, reagents, etc.) per location, a minimum of 12 analysts or independent teams of analysts, and training of the teams. Methods undergoing successful validation and approved by the OMB would first receive Official MethodsSM status for laboratory use. Once acceptable verification data has been collected for field use, the method would then obtain Official MethodSM status for field use. The collaborative study protocol provides a companion process for AOAC’s proposed Biological Threat Agent Method (BTAM) Validation Guideline, a comprehensive technical guideline to standardize the method validation process for bacterial threat agent detection methods, and complements all of AOAC’s many activities in the biothreat detection community. “With the new protocol, AOAC is thinking outside the box,” said Bradford. “It is a means to serve the public and community, so that we can continue to advance this critical work to help establish an enduring national capacity.” Full coverage is scheduled for the May/June issue of Inside Laboratory Management.
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