Microbiology Methods for ERP Review 3-2020
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Table 2020.01B : Comparative Results for the Detection of Salmonella in 375 g Instant NFDM Test Portions by the Solus One Salmonella vs. FDA/BAM Chapter 1 5 in a Collaborative Study (Uninoculated Control) 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) Instant NFDM 2 a NA NA NA NA NA NA NA NA NA NA NA NA NA NA 3 12 0 0.00 12 0 0.00 12 0 0.00 12 1 0.08 -0.08 0.00 4 12 0 0.00 12 0 0.00 12 0 0.00 12 0 0.00 0.00 0.00 5 a NA NA NA NA NA NA NA NA NA NA NA NA NA NA 6 12 0 0.00 12 0 0.00 12 0 0.00 12 0 0.00 0.00 0.00 7 12 0 0.00 12 0 0.00 12 0 0.00 12 0 0.00 0.00 0.00 8 12 0 0.00 12 0 0.00 12 0 0.00 12 0 0.00 0.00 0.00 9 12 0 0.00 12 0 0.00 12 0 0.00 12 0 0.00 0.00 0.08 dLPOD (C,R) dLPOD (CP,CC) 1 12 0 0.00 12 0 0.00 12 0 0.00 12 0 0.00 0.00 0.00
10 a NA NA NA NA NA NA NA NA NA NA NA NA NA NA 11 12 0 0.00 12 0 0.00 12 0 0.00 12 0 0.00 0.00 0.00 12 12 0 0.00 12 0 0.00 12 0 0.00 12 0 0.00 0.00 0.00
13 12 0 0.00 12 0 0.00 12 0 0.00 12 0 0.00 0.00 0.00
14 12 0 0.00 12 0 0.00 12 0 0.00 12 0 0.00 0.00 0.00
Estimate All 132 0 0.00 132 0 0.00 132 0 0.00 132 1 0.01 -0.01 0.00 LCL 0.00 0.00 0.00 0.00 -0.02 -0.02
UCL 0.03 0.03 0.03 0.04 0.04 0.02 s r
c 0.00 0.00 0.00 0.09
LCL 0.00 0.00 0.00 0.08
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 0.04 s R
e 0.00 0.00 0.00 0.09
UCL 0.00 0.00 0.00 0.08
LCL 0.23 0.23 0.23 0.10 P T
f 1.0000 1.0000 1.0000 0.4338
3 a N/A – Collaborator did not complete testing, b The alternative confirmation and the FDA/BAM Chapter 5 confirmation produced identical results, 4 c Repeatability Standard Deviation, d Among-Laboratory Standard Deviation, e Reproducibility Standard Deviation, f P T Value = Homogeneity test of laboratory PODs 5 N - Number of Test Portions; X – Number of Positive Test Portions; LCL – Lower Confidence Limit; UCL – Upper Confidence Limit 6
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