ERP Micro December 2019

bioMérieux, Inc. GENEUP ® Listeria monocytogenes 2 (LMO 2) AOAC ® Certification Number 121804

Table 18. GENE-UP Unit Dose vs. GENE UP Multi Dose – POD Results (14)

GENE-UP Unit Dose

GENE UP Multi Dose

Contamination level, cfu/Test Portion

Matrix

GENE UP Test Kit

N a

dPOD e

95% CI f

X b

POD UD c

95% CI

X b

POD MD d

95% CI

0

5

0

0.00

0.00, 0.43

0

0.00

0.00, 0.43

0.00

-0.43, 0.43

Stainless steel (4” x 4”) environmental sponge

GENE-UP LMO

Target-7 Competitor-70 Target-25 Competitor- 250

20

17

0.85

0.64, 0.95

17

0.85

0.64, 0.95

0.00

-0.13, 0.13

5

5

1.00

0.57, 1.00

5

1.00

0.57, 1.00

0.00

-0.43, 0.43

a N = Number of test portions b X = Number of positive test portions c POD UD = Unit Dose confirmed positive outcomes divided by the total number of trials d POD MD = Multi Dose confirmed positive outcomes divided by the total number of trials e dPOD = Difference between the Unit Dose result and Multi Dose result POD values f 95% CI = If the confidence interval of a dPOD does not contain zero, then the difference is statistically significant at the 5% level g MPN is reported as greater than the lower confidence limit as all samples were positive in MPN determination.