Microbiology Methods for ERP Review 3-2020

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Table 2020.01A : Summary of Results for the Detection of Salmonella

1

Method a

Solus One Salmonella

Un-inoculated

Low

High

Inoculation Level

Candidate Presumptive Positive/ Total # of Samples Analyzed Candidate Presumptive LPOD (CP)

0/132

57/132

132/132

0.00 (0.00, 0.03) 0.00 (0.00, 0.16) 0.00 (0.00, 0.16) 0.00 (0.00, 0.23)

0.43 (0.34, 0.52) 0.51 (0.45, 0.52) 0.00 (0.00, 0.12) 0.51 (0.46, 0.52)

1.00 (0.97, 1.00) 0.00 (0.00, 0.16) 0.00 (0.00, 0.16) 0.00 (0.00, 0.23)

s r b s L c s R d

P Value e

1.0000

0.9743

1.0000

Candidate Confirmed Positive/ Total # of Samples Analyzed Candidate Confirmed LPOD (CC)

0/132

58/132

132/132

0.00 (0.00, 0.03) 0.00 (0.00, 0.16) 0.00 (0.00, 0.16) 0.00 (0.00, 0.23)

0.44 (0.35, 0.53) 0.51 (0.45, 0.52) 0.00 (0.00, 0.13) 0.51 (0.46, 0.52)

1.00 (0.97, 1.00) 0.00 (0.00, 0.16) 0.00 (0.00, 0.16) 0.00 (0.00, 0.23)

s r

s L s R

P Value

1.0000

0.9417

1.0000

Candidate Confirmed Positive/ Total # of Samples Analyzed Candidate Presumptive Positive that Confirmed LPOD (C)

0/132

57/132

132/132

0.00 (0.00, 0.03)

0.43 (0.34, 0.52)

1.00 (0.97, 1.00)

s r

0.00 (0.00, 0.16) 0.00 (0.00, 0.16) 0.00 (0.00, 0.23)

0.51 (0.45, 0.52) 0.00 (0.00, 0.12) 0.51 (0.46, 0.52)

0.00 (0.00, 0.16) 0.00 (0.00, 0.16) 0.00 (0.00, 0.23)

s L s R

P Value

1.0000

0.9743

1.0000

Positive Reference Samples/ Total # of Samples Analyzed

1/132

48/132

132/132

Reference LPOD

0.01 (0.00, 0.04) 0.09 (0.08, 0.16) 0.00 (0.00, 0.04) 0.09 (0.08, 0.10)

0.36 (0.28, 0.45) 0.49 (0.44, 0.52) 0.00 (0.00, 0.14) 0.49 (0.44, 0.52)

1.00 (0.97, 1.00) 0.00 (0.00, 0.16) 0.00 (0.00, 0.16) 0.00 (0.00, 0.23)

s r

s L s R

P Value

0.4338

0.9210

1.0000

dLPOD (Candidate vs. Reference) f dLPOD (Candidate Presumptive vs. Candidate Confirmed) f,g

-0.01 (-0.02, 0.04)

0.07 (-0.12, 0.17)

0.00 (-0.06, 0.06)

0.00 (-0.02, 0.02) 0.00 (-0.06, 0.06) a Results include 95% Confidence Intervals, r Repeatability Standard Deviation, c Among-Laboratory Standard Deviation, d Reproducibility Standard Deviation 2 e P Value = Homogeneity test of laboratory PODs; f A confidence interval for dLPOD that does not contain the value 0 indicates a statistically significant difference 3 between the two methods; g Both the alternative confirmation procedure and the confirmation procedure following the FDA/BAM Chapter 5 produced identical results -0.01 (-0.20, 0.15)

4 5 6 7 8 9

10 11 12 13 14

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