Validation of the 3M™ Molecular Detection Assay 2—STEC Gene Screen (stx) for Detection of Shiga-Toxin Gene (stx1 and/or stx2) in Dried Cannabis Flower and Dried Hemp Flower: AOAC® Performance Tested MethodSM 071903

The 3M™ Molecular Detection Assay 2 - STEC Gene Screen (stx) method is based on gene amplification by the use of real time loop-mediated isothermal amplification when used with the 3M Molecular Detection System for the rapid and specific detection of Shiga toxin gene (stx1 and/or stx2) from Shiga toxin-producing Escherichia coli (STEC) in enriched products. The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) was approved as AOAC® Performance Tested MethodSM Certificate No. 071903.This matrix extension study evaluated the 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) method for detection of STECs in dried cannabis flower [>0.3% delta 9-tetrahydrocannabinol (THC)] and dried hemp flower (≤0.3% THC) at a 10 g test portion size.Testing followed procedures outlined in 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) Product Instructions and Standard Method Performance Requirements (SMPRs®) for Detection of Shiga toxin-producing Escherichia coli in Cannabis and Cannabis Products (AOAC SMPR 2020.012). The method was evaluated at low, high, and non-inoculated levels.Results showed no statistically significant difference between the presumptive positive 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) results and the SMPR 2020.012 recommended cultural confirmations.This study provides data that demonstrate the 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) is a reliable method for the rapid and specific detection of STECs in dried cannabis flower and dried hemp flower.The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) method is suitable for the rapid and specific detection of STECs in dried cannabis flower and dried hemp flower.