122 / 453
3M MDA2 E. coli O157:H7 Collaborative Study
May 2016
OMA-2016-May-XXXX
DRAFT DOCUMENT
15
Appendix 8.3
1
Study Materials
2
3
Materials provided by collaborator
4
a)
Pipettes
. – Capable of 20µL
5
b)
Multi-channel pipette
. – Capable of 20µL
6
c)
Sterile pipette tips.
– Capable of 20µL
7
d)
Serological Pipette Bulbs (Automatic Pippette)
– For sampling and delivering of 1 mL - 10 mL
8
e)
Serological pipettes
. – Aerosol resistant
9
f)
Stomacher®
. – Seward or equivalent
10
g)
Filter Stomacher® bags
. – Seward or equivalent
11
h)
Thermometer
. – Calibrated range to include 100 ± 1°C range
12
i)
Incubators
. – Capable of maintaining 42 ± 1°C, 35 ± 2°C, and 41.5 ± 1°C
13
j)
Dry Bath Incubator
. – Capable of maintaining a temperature of 100 ± 1 ºC
14
k)
Dry double block heater unit.
– Capable of maintaining 100 ± 1°C; or
a water bath
capable of
15
maintaining 100 ± 1°C
16
l)
Refrigerator
. – capable of maintaining 2-8°C, for storing the 3M MDA2
17
m)
Computer
. – compatible with the 3M Molecular Detection System (instrument)
18
19
Materials and reagents provided by the study sponsor
20
a)
3M MDA2 –
E. coli O157
(including H7) Test Kits
21
b)
3M Molecular Detection System (instrument), power supply, cord, USB cable and software
22
c)
3M Molecular Detection Speed Loader Tray
23
d)
3M Molecular Detection Chill Block Tray and Chill block insert
24
e)
3M Molecular Detection Heat Block Insert
25
f)
3M Molecular Detection Cap/Decap Tool [Reagent]
26
g)
3M Molecular Detection Cap/Decap Tool [Lysis]
27
h)
Empty lysis tube rack
28
i)
Empty reagent tube rack
29
j)
3M™ Enrichment Pouch with 225 mL Buffered Peptone Water (ISO formulation) and filter,
30
available from 3M #QEBPWI225F
31
k)
Matrix Control, available from 3M #MDMC96NA
32
33
Media and Reagents
34
a)
Modified tryptone soya broth (mTSB)
35
b)
Modified Rainbow agar (mRBA)
36
c)
Tryptic soy agar with 5% sheep blood (SBA)
37
d)
Antibody screening test
38
e)
Dynal antibody coated paramagnetic beads
39
f)
1N hydrochloric acid (HCl)
40
g)
Biochemical confirmation supplies
41
h)
Serological confirmation supplies
42
43
44
OMAMAN-35 B: Collaborative Study Protocol
ERP USE ONLY
January 2017
AOAC Research Institute
Expert Review Panel Use Only