AOAC-RI ERP Micro June 2016

OMAMAN-29 D/ PTM Validation Report 111501 OMA ERP - June 2016 ERP Use Only

h) Dry double block heater unit. – capable of maintaining 100 ± 1°C; or a water bath

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capable of maintaining 100 ± 1°C

i) Refrigerator . – capable of maintaining 2-8°C, for storing the 3M MDA2 j) Computer . – compatible with the 3M Molecular Detection System (instrument)

Safety Precautions

The user should read, understand and follow all safety information in the instructions for the 3M Molecular Detection System and the 3M Molecular Detection Assay 2 - Listeria . Retain the

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safety instructions for future reference.

As with all test methods, the source, formulation and quality of enrichment medium can influence the results. Factors such as sampling methods, testing protocols, sample preparation, handling, and laboratory technique may also influence results. 3M recommends evaluation of the method including enrichment medium, in the user’s environment using a sufficient number of samples with particular foods and microbial challenges to ensure that the method meets the The 3M Molecular Detection Assay 2 - Listeria method may generate Listeria monocytogenes to levels sufficient to cause stillbirths and fatalities in pregnant women and the To reduce the risks associated with exposure to chemicals and biohazards: • It is strongly recommended that female laboratory staff be informed of the risk to a developing fetus resulting from infection of the mother through exposure to Listeria monocytogenes • Perform pathogen testing in a properly equipped laboratory under the control of trained personnel • Always follow standard laboratory safety practices, including wearing appropriate protective apparel and eye protection while handling reagents and contaminated samples • Avoid contact with the contents of the enrichment media and reagent tubes after amplification • Dispose of enriched samples according to current industry standards user’s criteria. immunocompromised, if exposed.

AOAC Research Institute Expert Review Panel Use Only

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Sample Preparation

3M recommends the use of Demi-Fraser Broth with FAC for the enrichment of food and environmental samples. Table 1 presents guidance for the enrichment of food and environmental samples. It is the user’s responsibility to validate alternate sampling protocols or dilution ratios

to ensure this test method meets the user’s criteria.

Foods

a) Allow the Demi-Fraser Broth enrichment medium (includes FAC) to equilibrate to ambient

laboratory temperature.

b) Aseptically combine the enrichment medium and sample according to Table 1. For all meat and highly particulate samples, the use of filter bags is recommended. c) Homogenize thoroughly by blending, stomaching, or hand mixing for 2 ±0.2 minutes.

Incubate at 37 ±1°C according to Table 1.