AOAC Approval for Assurance GDS® Shiga Toxigenic E. coli (STEC) Detection Assay

BioControl Systems, Inc., has received AOAC Research Institute Performance Tested Method approval for two genetic methods for the detection of Shiga Toxigenic E. coli (STEC). Assurance GDS MPX Top 7 STEC, Certificate 07130, is a single assay that separately detects both E. coli O157:H7 and the 'Big 6' non-O157 STEC as defined by USDA FSIS. The second method, Certificate 071303 is a sequential assay approach utilizing Assurance GDS Top 7 STEC (eae) followed by Assurance GDS Shiga Toxin Genes (Top 7) to detect the top 7 serogroups of STEC, including O157.

Both Assurance GDS methods combine a proprietary IMS-based sample preparation procedure specifically targeting the top 7 O serogroups (O26, O45, O103, O111, O121, O145 and O157) followed by PCR analysis for the detection of the eae and stx1 and stx2 genes. This approach satisfies the USDA criteria for detection of STEC and minimizes the potential for false positives caused by other O serogroups. Additionally, the Assurance GDS MPX assay also includes primers and probes for the same highly specific target sequence for E. coli O157:H7 used in the Assurance GDS for E. coli O157:H7 assay (AOAC OMA 2005.04). This enables the MPX assay to provide a separate and distinct result for E. coli O157:H7 as well as the remaining Top 6 non-O157 STEC in a single test. Both methods can provide results in as little as 12 hours and received 'Letters of No Objection' from the United States Department of Agriculture Food Safety Inspection Service (USDA FSIS) in 2012

The Assurance GDS pathogen detection system includes assays for Non-O157 STEC, E coli O157:H7, Shiga Toxin Genes, Salmonella, Listeria spp., Listeria monocytogenes, and Cronobacter. Assays have been validated by a variety of 3rd parties including AOAC, AFNOR, MicroVal, and Health Canada as well as several multinational food manufacturing companies.