Review Book

3/12/2020

AOAC OMAMLV Study Overview

Objective: To evaluate the reproducibility of the bioMérieux GENE ‐ UP Salmonella 2 (SLM2) in a multi ‐ laboratory validation to obtain AOAC First Action Official Method of Analysis Certification (OMA). Reference Method: USDA FSIS MLG 4.10 Matrix: Raw Ground Beef Test Portion Size: 375 g – GENE ‐ UP SLM; 25 g – FSIS (unpaired) Test Replicates per Collaborator: 72 Total Replicates (36 per method); 12 Control, 12 Low (fractional); 12 High Collaborators: 15 from 14 different laboratories Statistics: dLPOD C with 95% CI: 0.00 ( ‐ 0.03, 0.03),  ‐ 0.02 ( ‐ 0.15, 0.12) and 0.02 ( ‐ 0.03, 0.09) Summary: no statistical difference in performance between the candidate method and reference method for the matrix evaluated

3

GENE ‐ UP Methodology

5µl

10 µl

 10 h enrichment  20 µL transfer to lysis tubes  5 min lysis @ 2200 rpm without heat

 10 µL lysate transfer to PCR reaction tubes  Centrifuge for 10s and initiate PCR run  Results obtained in <1 h

4

2