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BioControl Systems receives additional “No Objection” Letters for Top 6 and Top 7 Shiga Toxigenic E. coli Test Methods



Bellevue, WA  BioControl Systems, Inc., a worldwide leader in food safety testing, has received additional “No Objection” letters from the United States Department of Agriculture Food Safety Inspection Service (USDA FSIS) for its Assurance GDS® methods for the detection of non-O157 STEC.  Four BioControl test methods for Top STEC have now been issued Letters of No Objection.

Assurance GDS combines the latest advancements in immunomagnetic separation (IMS), molecular technology, and food microbiology to provide four new methods for the detection of the major non-O157 serotypes of Shiga Toxigenic E. coli (STEC) O26, O45, O103, O111, O121, O145 and E. coli O157:H7. “No Objection” letters were received for the following methods: Assurance GDS Top 7 STEC MPX, Assurance GDS Top 6 STEC MPX, Assurance GDS Top 7 STEC (eae), and Assurance GDS Top 6 STEC (eae).  

The Assurance GDS pathogen detection methods include a proprietary IMS-based sample preparation procedure specifically targeting either the top 6 or 7 O serogroups followed by PCR analysis for the detection of the eae and stx1and stx2 genes. This approach satisfies the USDA criteria for detection of STEC. The Assurance GDS methodology targets the STEC genetic sequences contained in the specific serogroups of concern and minimizes false positives from other O serogroups while eliminating the need for additional time consuming and costly analysis. There are several testing options now available for labs to choose from, with assays targeting the Top 7 STEC, including E. coli O157:H7, or only the Top 6 non-O157 serogroups. “With Assurance GDS Top 7 STEC MPX, producers can obtain results for both E. coli O157:H7 and the top non-O157 STEC from a single enriched sample and with a single test, after as little as 10 hours of incubation”, explained Anita Kressner, VP Global Sales and Marketing. “Alternately, the Assurance GDS Top 7 STEC (eae) method allows for the sequential analysis of the top non-O157 STEC and E. coli O157:H7 by conducting the IMS sample procedure targeting the top 7 O serogroups, followed by screening first for eae,” states Kressner. If the sample is negative no further testing is required. If positive, the same sample broth is analyzed with the Assurance GDS Top 7 Shiga Toxin genes kit. These Assurance GDS assays are also available in a Top 6 format that excludes E. coli O157 for those organizations that want to use separate methods for O157.  

BioControl has been a recognized leader in the development of innovative rapid microbiological tests for the food industry since 1985.  We offer an extensive line of proprietary, rapid tests for pathogen detection, quality control, and hygiene monitoring.  For more information please contact us at info@biocontrolsys.com.