Microbiology Methods for ERP Review 3-2020

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Table 2020.01B (cont’d.) : Comparative Results for the Detection of Salmonella in 375 g Instant NFDM Test Portions by the Solus One Salmonella vs. 1 FDA/BAM Chapter 5 in a Collaborative Study (High Inoculum Level) 2 Statistic Matrix Collaborator Candidate presumptive (CP) Candidate confirmed (CC) b Candidate result (C) Reference method (R) C vs. R CP vs. CC N X POD (CP) N X POD (CC) N X POD (C) N X POD (R) dLPOD (C,R) dLPOD (CP,CC) Instant NFDM 1 12 12 1.00 12 12 1.00 12 12 1.00 12 12 1.00 0.00 0.00 2 a NA NA NA NA NA NA NA NA NA NA NA NA NA NA 3 12 12 1.00 12 12 1.00 12 12 1.00 12 12 1.00 0.00 0.00 4 12 12 1.00 12 12 1.00 12 12 1.00 12 12 1.00 0.00 0.00 5 a NA NA NA NA NA NA NA NA NA NA NA NA NA NA 6 12 12 1.00 12 12 1.00 12 12 1.00 12 12 1.00 0.00 0.00 7 12 12 1.00 12 12 1.00 12 12 1.00 12 12 1.00 0.00 0.00 8 12 12 1.00 12 12 1.00 12 12 1.00 12 12 1.00 0.00 0.00 9 12 12 1.00 12 12 1.00 12 12 1.00 12 12 1.00 0.00 0.00 10 a NA NA NA NA NA NA NA NA NA NA NA NA NA NA MPN/ Test Portion 5.44 2.50 19.54 11 12 12 1.00 12 12 1.00 12 12 1.00 12 12 1.00 0.00 0.00 12 12 12 1.00 12 12 1.00 12 12 1.00 12 12 1.00 0.00 0.00 13 12 12 1.00 12 12 1.00 12 12 1.00 12 12 1.00 0.00 0.00 14 12 12 1.00 12 12 1.00 12 12 1.00 12 12 1.00 0.00 0.00 Estimate All 132 132 1.00 132 132 1.00 132 132 1.00 132 132 1.00 0.00 0.00 LCL 0.97 0.97 0.97 0.97 -0.06 -0.06 UCL 1.00 1.00 1.00 1.00 0.06 0.06 s r c 0.00 0.00 0.00 0.00 LCL 0.00 0.00 0.00 0.00 UCL 0.16 0.16 0.16 0.16 s L d 0.00 0.00 0.00 0.00 LCL 0.00 0.00 0.00 0.00 UCL 0.16 0.16 0.16 0.16 s R e 0.00 0.00 0.00 0.00 UCL 0.00 0.00 0.00 0.00 LCL 0.23 0.23 0.23 0.23 P T f 1.0000 1.0000 1.0000 1.0000

a N/A – Collaborator did not complete testing, b The alternative confirmation and the FDA/BAM Chapter 5 confirmation produced identical results, 3 c Repeatability Standard Deviation, d Among-Laboratory Standard Deviation, e Reproducibility Standard Deviation, f P T Value = Homogeneity test of laboratory PODs 4 N - Number of Test Portions; X – Number of Positive Test Portions; LCL – Lower Confidence Limit; UCL – Upper Confidence Limit 5 6