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It is the user’s responsibility in selecting any test method or product to evaluate a sufficient

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number of samples with the appropriate matrices and microbial challenges to satisfy the user

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that the chosen test method meets the user’s criteria.

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It is also the user’s responsibility to determine that any test methods and results meet its

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customers’ and suppliers’ requirements.

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As with any test method, results obtained from use of any 3M Food Safety product do not

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constitute a guarantee of the quality of the matrices or processes tested.

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To help customers evaluate the method for various food matrices, 3M has developed the 3M™

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Molecular Detection Matrix Control kit. When needed, use the Matrix Control (MC) to determine

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if the matrix has the ability to impact the 3M Molecular Detection Assay 2 -

Listeria

10

monocytogenes

results. Test several samples representative of the matrix, i.e. samples

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obtained from different origin, during any validation period when adopting the 3M method or

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when testing new or unknown matrices or matrices that have undergone raw material or

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process changes.

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A matrix can be defined as a type of product with intrinsic properties such as composition and

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process. Differences between matrices may be as simple as the effects caused by differences

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in their processing or presentation for example, raw vs. pasteurized; fresh vs. dried, etc.

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STORAGE AND DISPOSAL

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Store the 3M Molecular Detection Assay 2 -

Listeria monocytogenes

at 2-8°C. Do not freeze.

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Keep kit away from light during storage. After opening the kit, check that the foil pouch is

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undamaged. If the pouch is damaged, do not use. After opening, unused reagent tubes should

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always be stored in the re-sealable pouch with the desiccant inside to maintain stability of the

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lyophilized reagents. Store resealed pouches at 2-8°C for no longer than 60days.

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Do not use 3M Molecular Detection Assay 2 -

Listeria monocytogenes

past the expiration date.

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Expiration date and lot number are noted on the outside label of the box. After use, the

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enrichment medium and the 3M Molecular Detection Assay 2 -

Listeria monocytogenes

tubes

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can potentially contain pathogenic materials. When testing is complete, follow current industry

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standards for the disposal of contaminated waste. Consult the Safety Data Sheet for additional

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information and local regulations for disposal.

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INSTRUCTIONS FOR USE

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Follow all instructions carefully. Failure to do so may lead to inaccurate results.

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AOAC Research Institute

Expert Review Panel Use Only

OMAMAN-29/OMAMAN-30 Combined Collaborative Study Protocol

OMA ERP - June 2016

ERP Use Only