Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

OMB Meeting 4-11-2019 Pre-read Materials

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OMAMAN-31 E: AOAC RI PTM Report 091501 ERP Use Only - March 2016

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rash. Typhoidal illness is a very serious condition; up to 10% of people who don’t receive treatment may die. Various types of food can become contaminated and cause gastrointestinal illness: meats, eggs, fruits and vegetables, and even dry foods like spices and raw tree nuts. The typhoidal illness usually is associated with sewage ‐ contaminated drinking water, or crops

irrigated with sewage ‐ contaminated water.

Salmonella has a host of vectors, including some pets, like turtles, other reptiles, and baby chickens. Important measures for preventing foodborne illness from Salmonella include thorough cooking, hand washing, keeping raw foods separated from cooked foods, and keeping foods at the correct temperature (refrigerate foods at 40 ºF or colder). [4]

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Principle of the Method

The 3M™ MDA 2 - Salmonella is used with the 3M™ Molecular Detection System for the rapid and specific detection of Salmonella in enrichments of food, animal feed and food process

environmental samples.

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 your preferred method or as specified by local regulations.

Precautions

The 3M MDA 2 - Salmonella is intended for use in a laboratory environment by professionals trained in laboratory techniques. 3M has not documented the use of this product in industries other than the food and beverage industries. For example, 3M has not documented this product for testing water, pharmaceutical, cosmetics, clinical or veterinary samples. The 3M MDA 2 - Salmonella has not been evaluated with all possible food products, food processes, testing

AOAC Research Institute Expert Review Panel Use Only

protocols or with all possible strains of bacteria.

As with all test methods, the source of enrichment medium can influence the results. The 3M MDA 2 - Salmonella has only been evaluated for use with the enrichment media specified in the

Instructions for Use section.

Materials and Methods

Test Kit Information

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

b) Catalog Number . — MDA2SAL96

Test Kit Reagents - 3M MDA2 - Salmonella (96 tests)

04/05/2019