ERP Micro December 2019

bioMérieux GENE-UP® Listeria species 2 (LIS 2) AOAC ® Certification Number 121803

0.00, 0.43 0.18, 0.57 0.57, 1.00

-

5

0

0.00

0

0.00

0.00, 0.43

0.00

-0.43, 0.43

L. mono. ATCC 751 & E. faecalis ATCC 29212

Stainless Steel (4” x 4”)

18 Hours

25 & 90

20

7

0.35

7

0.35

0.18, 0.57

0.00

-0.28, 0.28

1250 & 4500

5

5

1.00

5

1.00

0.57, 1.00

0.00

-0.43, 0.43

a MPN = Most Probable Number is calculated using the LCF MPN calculator provided by AOAC RI, with 95% confidence interval b N = Number of test portions c x = Number of positive test portions d POD CP = Candidate method presumptive positive outcomes divided by the total number of trials e POD CC = Candidate method confirmed positive outcomes divided by the total number of trials f dPOD CP = Difference between the candidate method presumptive result and candidate method confirmed result POD values g 95% CI = If the confidence interval of a dPOD does not contain zero, then the difference is statistically significant at the 5% level h CFU/Test Area = Results of the CFU/Test area were determined by plating the inoculum for each matrix in triplicate

Table 8. INDEPENDENT LABORATORY - GENE-UP ™ Listeria species Assay, Candidate vs. Reference – POD Results (4)

Candidate

Reference

MPN a / Test Portion

Matrix/Test Portion

Time Point

Strain

N b

dPOD C f

95% CI g

x c

POD C d

95% CI

X

POD R e

95% CI

0.00, 0.43 0.22, 0.61 0.57, 1.00

0.00, 0.43 0.22, 0.61 0.57, 1.00

-0.43, 0.43 -0.28, 0.28 -0.43, 0.43

0

0.00

0.00

-

5

0

0.00

Deli Ham (125 g)

L. seeligeri ATCC 35967

24 Hours

0.57 (0.31, 0.96) 20

8

0.40

8

0.40

0.00

2.29 (1.05, 5.02)

5

5

1.00

5

1.00

0.00

Candidate

Reference

MPN a / Test Portion

Matrix/Test Portion

Time Point

Strain

N b

dPOD C f

95% CI g

x c

POD C d

95% CI

X

POD R e

95% CI

0.00, 0.43 0.11, 0.47 0.57, 1.00

0.00, 0.43 0.18, 0.57 0.57, 1.00

-0.43, 0.43 -0.36, 0.18 -0.43, 0.43

0

0.00

0.00

-

5

0

0.00

Smoked Salmon (25 g)

L. mono. ATCC 15313

22 Hours

0.45 (0.22, 0.78) 20

5

0.25

7

0.35

-0.10

3.01 (1.31, 6.89)

5

5

1.00

5

1.00

0.00

Candidate

Reference

MPN a / Test Portion

Matrix/Test Portion

Time Point

Strain

N b

dPOD C f

95% CI g

x c

POD C d

95% CI

X

POD R e

95% CI

0.00, 0.43 0.11, 0.47 0.57, 1.00

0.00, 0.43 0.08, 0.42 0.57, 1.00

-0.43, 0.43 -0.21, 0.30 -0.43, 0.43

-

5

0

0.00

0

0.00

0.00

Mexican Soft Cheese (25 g)

0.25 (0.10, 0.48) 20

L. mono. ATCC 51778

22 Hours

5

0.25

4

0.20

0.05

2.29 (1.05, 5.02)

5

5

1.00

5

1.00

0.00

Matrix/Test

Strain

Time

CFU h /

N b

Candidate

Reference

dPOD C f

95% CI g