ERP Micro December 2019

Inclusivity Evaluation

For the inclusivity evaluation of the GDS EHEC assay, 50 isolates of E . coli O157:H7 were cultured in mEHEC® media for 18–24 h at 42 ± 1°C. The cultures tubes were diluted to 100x the Limit of Detection (LOD 50 ). The target and non-target organisms were enriched, serially diluted and tested, consistent with Appendix J , using the PPMX following the manufacturer’s Directions for Use.

Inclusivity Results

When analyzed on the PPMX, all 50 inclusivity E. coli O157:H7 isolates also were correctly identified by GDS EHEC. Detailed results for the cultural inclusivity study are presented in Table 1 . Table 1: Assurance® GDS for E . coli O157:H7 Inclusivity Results PIPETMAX® – from mEHEC® Broth

Page 22 of 34