ERP Micro December 2019

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

Table 6. INTERNAL LABORATORY - GENE-UP ™ Listeria species Assay, Candidate vs. Reference – POD Results (4)

Candidate

Reference

MPN a / Test Portion

Time Point

95% CI g

Matrix/Test Portion

Strain

N b

dPOD C f

95% CI

95% CI

x c

POD C d

X

POD R e

0.00, 0.43

0.00, 0.43

-0.43, 0.43

-

5

0

0.00

0

0.00

0.00

L. seeligeri ATCC 35967

0.87 (0.51, 1.43)

Deli ham (25 g)

22 Hours

0.30, 0.70

0.39, 0.78

-0.37, 0.19

20

10

0.50

12

0.60

-0.10

>10 (2, >10)

0.57, 1.00

0.57, 1.00

-0.43, 0.43

5

5

1.00

5

1.00

0.00

Candidate

Reference

MPN a / Test Portion

Time Point

95% CI g

Matrix/Test Portion

Strain

N b

dPOD C f

95% CI

95% CI

x c

POD C d

X

POD R e

0.00, 0.43

0.00, 0.43

-0.43, 0.43

-

5

0

0.00

0

0.00

0.00

L. mono. ATCC 23074

1.25 (0.79, 2.08)

0.39, 0.78

0.43, 0.82

-0.32, 0.23

Beef hot dogs (25 g)

22 Hours

20

12

0.60

13

0.65

-0.05

>10 (2, >10)

0.57, 1.00

0.57, 1.00

-0.43, 0.43

5

5

1.00

5

1.00

0.00

Candidate

Reference

MPN a / Test Portion

Time Point

95% CI g

Matrix/Test Portion

Strain

N b

dPOD C f

95% CI

95% CI

x c

POD C d

X

POD R e

0.00, 0.43

0.00, 0.43

-0.43, 0.43

-

5

0

0.00

0

0.00

0.00

1.42 (0.89, 2.47)

L. innocua ATCC 33090

0.43, 0.82

0.53, 0.89

-0.36, 0.18

Deli turkey (25 g)

22 Hours

20

13

0.65

15

0.75

-0.10

>10 (2, >10)

0.57, 1.00

0.57, 1.00

-0.43, 0.43

5

5

1.00

5

1.00

0.00

Candidate

Reference

MPN a / Test Portion

Time Point

95% CI g

Matrix/Test Portion

Strain

N b

dPOD C f

95% CI

95% CI

x c

POD C d

X

POD R e

0.00, 0.43

0.00, 0.43

-0.43, 0.43

-

5

0

0.00

0

0.00

0.00

Cooked chicken nuggets (25 g)

L. welshimeri ATCC 35897

1.32 (0.82, 2.34)

0.48, 0.85

0.53, 0.89

-0.31, 0.22

22 Hours

20

14

0.70

15

0.75

-0.05

>10 (2, >10)

0.57, 1.00

0.57, 1.00

-0.43, 0.43

5

5

1.00

5

1.00

0.00

Candidate

Reference

MPN a / Test Portion

Time Point

95% CI g

Matrix/Test Portion

Strain

N b

dPOD C f

95% CI

95% CI

x c

POD C d

X

POD R e

Cooked shrimp (25 g)

L. ivanovii ATCC

22 Hours

0.00, 0.43

0.00, 0.43

-0.43, 0.43

-

5

0

0.00

0

0.00

0.00