ERP Micro December 2019

DISCUSSION OF MODIFICATION APPROVED DECEMBER 2018 (8) Formerly known as PTM 051603 GENE-UP® Listeria species Detection Kit, now known as PTM 121803 GENE-UP® Listeria species 2 (LIS 2) This modification study performed a side by side comparison of a new format (Unit Dose vs Multi Dose) at both previous (US) and new (France) manufacturing facilities. This was done in two parts. First, a QC study was completed to monitor the parameters of the analysis for the Unit Dose method to ensure all were within the specifications. The second part was a matrix study evaluating the new Unit Dose in comparison to the current reference method as well as the previous Multi Dose method to ensure no differences even in the presence of foods. There were no differences seen between the presumptive and confirmed Unit Dose results nor for the Unit Dose vs Multi Dose results (all results were identical). Results between the Unit Dose and reference method showed no statistically significant differences using POD analysis.

Table 16. GENE-UP Unit Dose Presumptive vs. GENE-UP Unit Dose Confirmed – POD Results

Presumptive

Confirmed

Enrichment Time

Contamination level, cfu/Test Portion

Matrix

GENE UP Test Kit

N a

dPOD CP e

95% CI f

X b

POD CP c

95% CI

X b

POD CC 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

Deli ham (125g) GENE-UP Listeria

24 h

0.49 (0.25, 0.84)

20

6

0.30

0.15, 0.52

6

0.30

0.15, 0.52

0.00

-0.13, 0.13

1.35 (0.73, 2.52)

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 CP = Candidate method presumptive positive outcomes divided by the total number of trials d POD CC = Candidate method confirmed positive outcomes divided by the total number of trials e dPOD CP = Difference between the candidate method presumptive result and candidate method confirmed 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.

Table 17. GENE-UP Unit Dose vs. Reference Method – POD Results

GENE-UP Unit Dose

Reference Method

Reference Method

Contamination level, cfu/Test Portion

Matrix

GENE UP Test Kit

N a

dPOD C e

95% CI f

X b

POD C c

95% CI

X b

POD R 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

Deli ham (125g)

USDA/FSIS MLG 8.09

GENE-UP Listeria

0.49 (0.25, 0.84)

20

6

0.30

0.15, 0.52

7

0.35

0.18, 0.57

-0.05

-0.32, 0.23

1.35 (0.73, 2.52)

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 C = Candidate method confirmed positive outcomes divided by the total number of trials d POD r = Reference method confirmed positive outcomes divided by the total number of trials e dPOD C = Difference between the candidate method presumptive result and candidate method confirmed 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.