Validation of the Thermo Scientific™ SureTect™ Campylobacter jejuni, C. coli and C. lari PCR Kit for the Detection of Campylobacter jejuni, C. coli and C. lari in Raw Poultry and Ready-to-Cook Poultry Products AOAC Performance Tested MethodSM 012101.

BACKGROUND The Thermo Scientific™ SureTect™ Campylobacter jejuni, C. coli and C. lari PCR Kit is a real-time PCR assay for the detection and differentiation of Campylobacter jejuni, Campylobacter coli and Campylobacter lari from raw poultry and ready-to-cook poultry products and environmental samples. OBJECTIVE The Thermo Scientific™ SureTect™ Campylobacter jejuni, C. coli and C. lari PCR Kit was evaluated for AOAC® Performance Tested Methods SM certification. METHODS Inclusivity/exclusivity, matrix studies, product consistency and stability, and robustness testing were conducted to assess the method's performance. In the matrix studies, the method was validated against United States and international reference methods for Campylobacter detection. RESULTS There were no statistically significant differences found in the matrix studies between the candidate and reference methods when analyzed by probability of detection (POD). All 52 inclusivity strains and none of the 51 exclusivity strains tested were detected by the assay. Robustness testing demonstrated that the assay gave reliable performance with specific method deviations outside of the recommended parameters, and the real-time stability testing demonstrated that there were no statistically significant differences between kit lots, validating the stated shelf life of the kit. CONCLUSIONS The data presented support the product claims that the Thermo Scientific SureTect Campylobacter jejuni, C. coli and C. lari PCR Assay is suitable for the detection and differentiation of C. jejuni, C. coli and C. lari from raw poultry and ready-to-cook poultry products and environmental samples. HIGHLIGHTS Presumptive results can be obtained in as little as 23 h. Microaerophilic incubators are not required for enrichment.