AOAC-RI ERP Book Micro Jan 19 2017

OMAMAN-35 B: Collaborative Study Protocol ERP USE ONLY January 2017

3M MDA2 E. coli O157:H7 Collaborative Study

May 2016

OMA-2016-May-XXXX

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Appendix 8.3

Study Materials

Materials provided by collaborator a) Pipettes . – Capable of 20µL

b) Multi-channel pipette . – Capable of 20µL 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) 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 18 19 20 Materials and reagents provided by the study sponsor a) 3M MDA2 – E. coli O157 (including H7) Test Kits

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AOAC Research Institute Expert Review Panel Use Only

Media and Reagents

a) Modified tryptone soya broth (mTSB) b) Modified Rainbow agar (mRBA) c) Tryptic soy agar with 5% sheep blood (SBA)

d) Antibody screening test

e) Dynal antibody coated paramagnetic beads

f)

1N hydrochloric acid (HCl)

g) Biochemical confirmation supplies h) Serological confirmation supplies

DRAFT DOCUMENT

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