Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

OMAMAN-30 D/ PTM Validation Report 081501 OMA ERP - June 2016 ERP Use Only

OMB Meeting 4-11-2019 Pre-read Materials

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b) Difference of Probabilities of Detection (dPOD).— Difference of probabilities of detection is the difference between any two POD values. If the confidence interval of a dPOD does not contain zero, then the difference is statistically significant at the 5% level.

Principle of the Method

3M™ Molecular Detection Assay 2 – Listeria monocytogenes is used with the 3M™ Molecular Detection System for the rapid and specific detection of Listeria species in enriched food and The 3M Molecular Detection Assays use loop-mediated isothermal amplification to rapidly amplify nucleic acid sequences with high specificity and sensitivity, combined with bioluminescence to detect the amplification. Presumptive positive results are reported in real- time while negative results are displayed after the assay is completed. Presumptive positive results should be confirmed using the laboratory’spreferred method or as specified by local Listeria is a small, Gram-positive rod that can be found in soil or carried by animals. Many foods have been associated with Listeria contamination: uncooked meats, uncooked vegetables, cantaloupe, pasteurized and unpasteurized milk, and other dairy and processed foods. [5] The resulting illness, listeriosis, from Listeria monocytogenes ingestion is rare but can be fatal. The disease may appear as meningitis in adults and can affect unborn children due to its ability to cross through the placenta. Listeria contamination often occurs post- cooking, before packaging as Listeria can survive longer under adverse environmental conditions that can most other vegetative bacteria that present a concern for the food safety industry. [6] Manufacturing facilities implement sanitation practices and regular surface screening for the presence of Listeria on food contact surfaces to monitor their food production environments. The 3M MDA2– Listeriamonocytogenes was developed to provide rapid and specific detection of Listeria monocytogenes in enriched food samples and on food environmental samples. regulations. General Information

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processing surfaces.

AOAC Research Institute Expert Review Panel Use Only

Materials and Methods

Test Kit Information

a) Kit Name. — Molecular Detection Assay 2 – Listeriamonocytogenes

b) Catalog Number . — MDA2LM96

Test Kit Reagents - 3M MDA2 – Listeria monocytogenes (96 tests) a) Lysis Solution (LS) tubes . – 96 (12 strips of 8 tubes) b) Listeria monocytogenes Reagent tubes . – 96 (12 strips of 8 tubes)

c) Extra caps. – 96 (12 strips of 8 caps) d) Reagent Control (RC). – 16 (2 pouches of 8)

e) Quick Start Guide

Additional Supplies and Reagents

04/05/2019