ERP Micro December 2019

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

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

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

Deli ham (125g)

GENE-UP Listeria

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 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.

REFERENCES CITED 1. Thatcher, Stephanie, Powers, Mike, Powell, Jenkyn, and Millward, Haleigh., Evaluation of the R.A.P.I.D.® LT Food Security System for Listeria Detection in Select Foods and Environmental Surfaces, AOAC® Performance Tested SM certification number 010901. 2. United States Food and Drug Administration, FDA Bacteriological Analytical Manual http://www.cfsan.fda.gov/~ebam/bam-10.html 3. GENE-UP ® Listeria spp.: Qualitative test for the detection of Listeria spp. in food and environmental samples. Draft 2. 2015 (Accessed November 2015) 4. Johnson, R., Dwivedi, H.P., Chablain, P., and Giovannetti, L., A Comparative Evaluation of the GENE-UP TM Listeria spp. Assay for the Detection of Listeria species in a Variety of Foods and Environmental Surfaces Modification Report, AOAC Performance Tested Methods SM 010901, New certificate 051603 Approved May 2016 5. United States Department of Agriculture Microbiological Laboratory Guidelines 8.09: Isolation and Identification of Listeria monocytogenes from Red Meat, Poultry, Egg Products, and Environmental Sponges. May 1 st , 2013. (Accessed November 2015) http://www.fsis.usda.gov/wps/wcm/connect/1710bee8-76b9-4e6c-92fc-fdc290dbfa92/MLG-8.pdf?MOD=AJPERES 6. AOAC Official Method 993.12 Listeria monocytogenes in Milk and Dairy Products: Selective Enrichment and Isolation Method, First Action 1993, Final Action 1996 (Accessed November 2015). 7. Johnson, R. and Mills, J., A Comparative Evaluation of the GENE-UP TM Listeria spp. Assay for the Detection of Listeria species in Liquid Whole Egg and Whey Powder Annual PTM Renewal: Matrix Extension Report, AOAC Performance Tested Methods SM 051603 Approved January 2017. 8. Johnson, R., Mills, J., Dutta, V., Taylor, N., and Briese, D., PTM Method Modification of the bioMérieux GENE-UP® System from Multi Dose Format to the Unit Dose Format for the GENE-UP SLM, LIS, LMO, ECO, and EHEC-EHI Assays, AOAC® Performance Tested SM certification number 121802. Approved December 2018