Assurance GDS Receives USDA 'No Objection' Letters for non-O157 STEC

BioControl Systems, Inc. has received 'No Objection' letters dated February 3, 2012 from the United States Department of Agriculture Office of Policy and Program Development (USDA OPPD) for its Assurance GDS® test methods for the detection of non-O157 STEC.

Assurance GDS combines the latest advancements in immuno concentration (IMS), molecular technology and food microbiology to provide two 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. A 'No Objection letter' was received for both the Assurance GDS Top STEC MPX and Assurance GDS Top 7 STEC (eae) test methods.

The Assurance GDS pathogen detection methods include a proprietary IMS-based sample preparation procedure specifically targeting the top 7 O serogroups 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. The Assurance GDS methodology targets the STEC genetic sequences contained in the specific serogroups of concern and minimizes false positives from other O serogroups and eliminates the need for additional time consuming and costly analysis.

'With Assurance GDS Top 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. The test kits to perform both methods are available form BioControl for immediate distribution.