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 (Low 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 4 0.33 12 4 0.33 12 4 0.33 12 6 0.50 -0.17 0.00 2 a NA NA NA NA NA NA NA NA NA NA NA NA NA NA 3 12 4 0.33 12 4 0.33 12 4 0.33 12 3 0.25 0.08 0.00 4 12 5 0.42 12 5 0.42 12 5 0.42 12 4 0.33 0.09 0.00 5 a NA NA NA NA NA NA NA NA NA NA NA NA NA NA 6 12 6 0.50 12 6 0.50 12 6 0.50 12 6 0.50 0.00 0.00 7 12 5 0.42 12 5 0.42 12 5 0.42 12 3 0.25 0.17 0.00 8 12 4 0.33 12 4 0.33 12 4 0.33 12 3 0.25 0.08 0.00 9 12 6 0.50 12 6 0.50 12 6 0.50 12 4 0.33 0.17 0.00 10 a NA NA NA NA NA NA NA NA NA NA NA NA NA NA MPN/ Test Portion 0.45 0.34 0.59 11 12 6 0.50 12 7 0.58 12 7 0.58 12 5 0.42 0.16 -0.08 12 12 5 0.42 12 5 0.42 12 5 0.42 12 4 0.33 0.09 0.00 13 12 5 0.42 12 5 0.42 12 5 0.42 12 5 0.42 0.00 0.00 14 12 7 0.58 12 7 0.58 12 7 0.58 12 5 0.42 0.16 0.00 Estimate All 132 57 0.43 132 58 0.44 132 57 0.43 132 48 0.36 0.07 -0.01 LCL 0.34 0.35 0.34 0.28 -0.12 -0.20 UCL 0.52 0.53 0.52 0.45 0.17 0.15 s r c 0.51 0.51 0.51 0.49 LCL 0.45 0.45 0.45 0.44 UCL 0.52 0.52 0.52 0.52 s L d 0.00 0.00 0.00 0.00 LCL 0.00 0.00 0.00 0.00 UCL 0.12 0.13 0.12 0.14 s R e 0.51 0.51 0.51 0.49 UCL 0.46 0.46 0.46 0.44 LCL 0.52 0.52 0.52 0.52 P T f 0.9743 0.9417 0.9743 0.9210

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 7 8