BioControl announces First DNA-based Rapid Tests for E coli O157:H7
Bellevue, WA (June, 2005) BioControl Systems, Inc., a worldwide leader in food safety testing, has become the first manufacturer to develop a DNA-based E coli O157:H7 assay and a Shiga Toxin genes assay to successfully complete the highly rigorous AOAC Official Method validation process. Through collaborative study by 15 independent laboratories, the Assurance GDS™ E coli O157:H7 assay (AOAC 2005.04) as well as the Shiga Toxin gene assay (AOAC 2005.05) were found to be equivalent to or better than the reference cultural method.

“The AOAC Official Methods process is universally recognized as the most demanding and significant mechanism for independent third party validation of an analytical method”, according to Phil Feldsine, President of BioControl. “The collaborative study validation is the ultimate proof that a group of analysts can consistently perform a method. This is particularly important for DNA-based methodology where precise technique is mandatory. “

The Assurance GDS genetic detection system combines the latest advancements in molecular technology and food microbiology to provide faster results with the increased accuracy required to meet today’s food and environmental testing challenges. Assurance GDS for E coli O157:H7 has been designed to provide results in a single, 8 hour shift. The Shiga Toxin genes assay is a companion assay that specifically measures the presence of Shigatoxin genes in samples containing E coli O157:H7. It can be used when supplemental information regarding the presence of Shigatoxin genes is desired.

In addition to faster results Assurance GDS also offers greater accuracy in the form of multiple layers of specificity. These include Immunomagnetic separation (IMS), highly specific primers, and a patented Probe system which ensure the highest degree of accuracy. Completing the system is the Assurance GDS Rotor-Gene™, an innovative multi-channel rotary cycler for the amplification and detection of the targets. The Assurance GDS Rotor-Gene can read multiple, distinct targets thereby eliminating the need for melt curves, which can be difficult and time consuming to interpret.

“This marks the first time ever, that DNA-based assays for E coli O157:H7 and for Shiga Toxin genes have successfully completed multi-laboratory validations and have been awarded AOAC Official Method status, “according to Maritta Ko, Vice President, Business Development at BioControl. “This is truly a milestone and represents a significant achievement for BioControl” says Ko. E coli O157:H7 and Shiga Toxin genes (STX1 and STX2) are the first assays to be developed on the Assurance GDS platform. Additional assays for Salmonella, Listeria and Listeria monocytogenes are currently in the final stages of development.

BioControl has been a recognized leader in the development of innovative rapid microbiological tests for the food industry since 1985. The company offers an extensive line of proprietary, rapid tests for pathogen detection, quality control, and hygiene monitoring. For more information contact BioControl at 425.603.1123.

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