41 / 596
3M MDA 2
Listeria
species and
L. monocytogenes
Collaborative Study
OMA-2016-MONTH-XXX
5/4/16
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.
8
9
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.
32
33
Information about this Collaborative Study
34
35
Shipment Schedule
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.
42
43
Test Portion Receipt
44
45
AOAC Rese rch Institute
Expert Review Panel Use Only
OMAMAN-29/OMAMAN-30 Combined Collaborative Study Protocol
OMA ERP - June 2016
ERP Use Only