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3M MDA 2

Listeria

species and

L. monocytogenes

Collaborative Study

OMA-2016-MONTH-XXX

5/4/16

4.1.10

Raw chicken fillet

(25 g): 28-32 hours of enrichment in Demi Fraser

broth at 37°C

4.1.11

Stainless steel

: sponge in 225 mL with 24-30 hours of enrichment in

Demi Fraser broth at 37°C

4.1.12

Concrete

: sponge in 100 mL and 225 mL and sponge in 225 mL with24-

30 hours of enrichment in Demi Fraser broth at 37°C

4.1.13

Plastic

: Enviroswab in 10 mL 24-30 hours of enrichment in Demi Fraser

broth at 37°C

Caution

:

The 3M MDA2 -

Listeria

is intended for use in a laboratory

environment by professionals trained in laboratory techniques. The user

should read, understand and follow all safety information in the instructions

for the 3M MDS and the 3M MDA2 -

Listeria

and retain the safety

instructions for future reference.

The 3M MDA 2 -

Listeria

method may generate

Listeria monocytogenes

to

levels sufficient to cause stillbirths and fatalities in pregnant women and the

immuno compromised, if exposed. The user must train its personnel in

current proper testing techniques: for example, Good Laboratory Practices,

ISO 17025, or ISO 7218.

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

results. The 3M Molecular Detection Instrument is intended for use with

samples that have undergone heat treatment during the assay lysis step, which

is designed to destroy organisms present in the sample. Samples that have not

been properly heat treated during the assay lysis step may be considered a

potential biohazard and should NOT be inserted into the 3M MDS

(instrument).

Store the 3M MDA2 -

Listeria

at 2-8°C. Do not freeze. Keep kit away from

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

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

reagent tubes should always be stored in the resealable pouch with the

desiccant inside to maintain stability of the lyophilized reagents. Store

resealed pouches at 2-8°C for no longer than 1 month. Do not use 3M

MDA2 -

Listeria

past the expiration date. Expiration date and lot number are

noted on the outside label of the box.

After use, the enrichment medium and the 3M MDA2 -

Listeria

tubes can

potentially contain pathogenic materials. When testing is complete, follow

current industry standards for the disposal of contaminated waste. Consult the

local regulations for disposal.

4.2

Test Kit Reagents -

3M MDA 2 -

Listeria

- 96 tests

4.2.1

Lysis Solution (LS) tubes

. – 96 (12 strips of 8 tubes)

4.2.2

Listeria Reagent tubes

. – 96 (12 strips of 8 tubes)

AOAC Research Institute

Expert Review Panel Use Only

OMAMAN-29/OMAMAN-30 Combined Collaborative Study Protocol

OMA ERP - June 2016

ERP Use Only