AOAC-RI ERP Micro June 2016

OMAMAN-29/OMAMAN-30 Combined Collaborative Study Protocol OMA ERP - June 2016 ERP Use Only

3M MDA 2 Listeria species and L. monocytogenes Collaborative Study OMA-2016-MONTH-XXX

The 3M MDA2 - Listeria monocytogenes 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 monocytogenes 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 MDA 2 - Listeria monocytogenes 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 MDA 2 - Listeria monocytogenes tubes can potentially contain pathogenic materials. When testing is complete, follow current industry standards for the disposal of contaminated waste. Consult local regulations for disposal. Test Kit Reagents - 3M MDA 2 - Listeria monocytogenes - 96 tests 5.2.1 Lysis Solution (LS) tubes . – 96 (12 strips of 8 tubes) 5.2.2 Listeria Reagent tubes . – 96 (12 strips of 8 tubes) 5.2.3 Extra caps. – 96 (12 strips of 8 caps) 5.2.4 Reagent Control (RC). – 16 (2 pouches of 8) 5.2.5 Quick Start Guide Additional Supplies and Reagents 5.3.1 3M Molecular Detection System (instrument), power supply, cord, USB cable and software 5.3.2 3M Molecular Detection Speed Loader Tray 5.3.3 3M Molecular Detection Chill Block Tray and Chill block insert 5.3.4 3M Molecular Detection Heat Block Insert AOAC Research Institute Expert Review Panel Use Only

5.2

5.3

5.3.5 3M Molecular Detection Cap/Decap Tool [Reagent] 5.3.6 3M Molecular Detection Cap/Decap Tool [Lysis]

5.3.7 Empty lysis tube rack 5.3.8 Empty reagent tube rack

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