The Validation of the VereBeef™ Detection Kit

VereBeef™ Detection Kit, incorporating both multiplex PCR and microarray technologies on a lab-on-chip platform, is intended for qualitative detection and differentiation of O157:H7, O26, O45, O103, O111, O121, O145, Shiga toxin-producing (STEC) virulence factors ( ), and species in one test using raw beef trim samples. This product underwent extensive evaluations, including inclusivity-exclusivity, method comparison, robustness, lot-to-lot variability, and stability studies. The inclusivity/exclusivity study demonstrated that VereBeef Detection Kit specifically detects and identifies target analytes without occurrence of false-positive and false-negative detection. In the method comparison study, the performance of the VereBeef Detection Kit was compared with U.S. Department of Agriculture Food Safety and Inspection Service Microbiology Laboratory Guidebook's methods for target organism detection in raw beef trim using O157:H7 single inoculation and and non-O157 STEC dual inoculation. Data demonstrated equivalence in both methods. The robustness study showed that changes in the test parameters do not impact assay performance. Collectively, VereBeef Detection Kit is able to detect target pathogens in raw beef trim with a minimum enrichment time of 8 h for O157:H7 detection and 10 h for and non-O157 STEC detection.