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Idaho Tech's PCR-Based Biothreat Detection System Wins AOAC Certification


Idaho Technology said this week that its Razor EX BioThreat Detection System has received approval and certification as an AOAC performance-tested method for detecting Bacillus anthracis spores collected from the air on filter or liquid matrices.

The Razor EX comprises a DNA extraction kit, a freeze-dried PCR reagent pouch, and a real-time PCR instrument. Each pouch contains three PCR assays, which distinguish potentially virulent B. anthracis from non-lethal B. anthracis and other Bacillus species.

The validation process consisted of three phases: evaluation by the method developer; testing by an independent laboratory; and collaborative testing by 12 independent operators. During the first two evaluation phases, 2,473 of 2,479 samples tested provided 99 percent success with 95 percent confidence, Idaho Tech said.

The platform is the first and only system to successfully pass this evaluation process, Idaho Tech said. The certification is part of a Department of Homeland Security-sponsored program with AOAC International and the AOAC Stakeholder Panel on Agent Detection Assays, or SPADA, to establish a national program for testing and validating biosurveillance systems to provide guidance to first responders, public health, and government agencies in procuring equipment.

The Scan

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