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

freeze. Keep kit away from light during storage. After opening the kit, check that the foil pouch 1 is undamaged. If the pouch is damaged, do not use. After opening, unused reagent tubes should 2 always be stored in the resealable pouch with the desiccant inside to maintain stability of the 3 lyophilized reagents. Store resealed pouches at 2-8°C for no longer than 1 month. Do not use 4 3M MDA2 Assays past the expiration date. Expiration date and lot number are noted on the 5 outside label of the box. After use, the enrichment medium and the 3M MDA2 tubes can 6 potentially contain pathogenic materials. When testing is complete, follow current industry 7 standards for the disposal of contaminated waste. Consult local regulations for disposal. 2. It is advised to make at least one practice run before the trial using your own materials so that 10 you can minimize errors in manipulations. Check that all pipettes, equipment, and 3M MDA2 11 supplies are on hand. 12 13 3. Make the determination on the specified date. Store the test portions according to the 14 instructions. It is essential for the validity of the trial that all collaborators commence the 15 analysis of each test portion on the designated day. Immediately upon receiving each shipment, 16 confirm the contents with the Study Director by faxing the form provided in the shipment. 17 18 4. THIS IS A STUDY OF THE METHOD, NOT OF THE LABORATORY. THE METHOD 19 MUST BE FOLLOWED AS CLOSELY AS PRACTICABLE, AND ANY DEVIATIONS 20 FROM THE METHOD AS DESCRIBED, NO MATTER HOW TRIVIAL THEY MAY SEEM, 21 MUST BE NOTED ON THE REPORT FORM. 22 23 5. Report all of your results as soon as analyses are completed. Do not do more or less than 24 indicated in the instructions. For example, do not do duplicate analysis and report the best or 25 average result. More or fewer results complicate the statistical analyses and may invalidate your 26 results. Data sheets are provided with these instructions and indicate which results are to be 27 reported. Please include any criticisms, suggested improvements, or general comments about the 28 3M MDAs on the Collaborators’ Comments Form provided. Any results that were derived from 29 modified protocols should be included but must be separated from the main report. Results and 30 comments should be returned to the Study Director immediately upon completion of each 31 portion of the study. 36 37 Test portions will be shipped by overnight courier to the collaborators to arrive on a Friday. Test 38 portion processing and analysis will begin on Monday. If the test portions do not arrive by the 39 normal delivery time one day prior to analysis, please contact a Study Director. All test portions 40 will be shipped refrigerated. Analysis of test portions must be initiated on the day scheduled 41 by the Study Director. Test kits and enrichment medium will be sent directly from 3M. AOAC Rese rch Institute Expert Review Panel Use Only 8 9 32 33 34 35 Information about this Collaborative Study Shipment Schedule

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Test Portion Receipt

5/4/16