Wednesday, July 25, 2012
Exhibit Hall (Rhode Island Convention Center)
Philip Feldsine, BioControl Systems, Inc., Bellevue, WA
David Kerr, BioControl Systems, Inc., Bellevue, WA
Markus Jucker, BioControl Systems, Inc., Bellevue, WA
Andrew Lienau, BioControl Systems, Inc., Bellevue, WA
Introduction: The United States Department of Agriculture (USDA) has proposed new regulations applicable to the analysis of certain raw beef products which define six
Shiga-toxigenic E.coli serotypes, in addition to O157, (“Top 7 STEC”) as adulterants. The Assurance GDS Top STEC MPX assay has been developed to provide an effective testing solution to satisfy this requirement. System components include Top 7 STEC serotype-specific immunomagnetic sample concentration reagents with the PickPen concentration device, amplification and identification reagents defining STEC genes eaeA (O157), eaeA STEC, stx1 and stx2, with Internal Control in a multiplex format; and microbiological confirmation reagents for Top 7 STEC isolates.
Purpose: To define the specificity (Inclusivity and Exclusivity) of the Assurance GDS Top STEC MPX assay for E.coli serotypes O26, O45, O103, O111, O121, O145, and O157.
Methods: Inclusivity was determined by analyzing a panel of 67 STEC strains representing all seven Top STEC serotypes. Exclusivity was determined by analyzing a panel of 31 strains representing potential cross-reactive microorganisms.
Results: Sixty-seven (67) E.coli Top 7 STEC inclusivity isolates were correctly identified and typed for the eaeA and stx genes by the MPX assay, with correct differentiation of eaeA (O157), and eaeA (STEC) genes. All 31 Exclusivity panel non-Top STEC strains gave negative results.
Significance: These results verify the accuracy of the Assurance GDS Top STEC MPX assay for the identification of Top 7 STEC organisms.
