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3M MDA2 E. coli O157:H7 Collaborative Study
May 2016
OMA-2016-May-XXXX
DRAFT DOCUMENT
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INTRODUCTION
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The goal of this collaborative study is to estimate the following performance parameters of
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the 3M™ Molecular Detection Assay 2 (MDA2) -
E. coli
O157 (including H7): probability of
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detection (POD) and the difference in the POD at 3 contamination levels for both the
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candidate and reference methods. Test portions from 3 different contamination levels,
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including negative controls, will be sent to collaborators where they will perform the 3M
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MDA2 -
E. coli
O157:H7 method along with the corresponding reference method. Raw fresh
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ground beef will be tested with 325 g test portion sizes.
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1.1
Description of the 3M™ MDA2 -
E. coli
O157 (including H7)
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The 3M™ Molecular Detection Assay 2 -
E. coli
O157 (including H7) is used with the 3M™
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Molecular Detection System for the rapid and specific detection of
E. coli
O157
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(including H7) in enriched food, feed and food process environmental samples.
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The 3M Molecular Detection Assays use loop-mediated isothermal amplification to
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rapidly amplify nucleic acid sequences with high specificity and sensitivity, combined
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with bioluminescence to detect the amplification. Presumptive positive results are
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reported in real-time while negative results are displayed after the assay is completed.
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Presumptive positive results should be confirmed using your preferred method or as
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specified by local regulations.
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The 3M Molecular Detection Assay 2 -
E. coli
O157 (including H7) is intended for use in a
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laboratory environment by professionals trained in laboratory techniques. 3M has not
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documented the use of this product in industries other than food or beverage. For
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example, 3M has not documented this product for testing pharmaceutical, cosmetics,
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clinical or veterinary samples. The 3M Molecular Detection Assay 2 -
E. coli
O157
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(including H7) has not been evaluated with all possible food products, food processes,
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testing protocols or with all possible strains of bacteria.
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1.2
Summary of Pre-collaborative Study
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The 3M MDA2 -
E. coli
O157 method was validated according to AOAC Guidelines (2012)
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in a pre-collaborative study. The aim of this study was to demonstrate that the 3M
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MDA2 -
E. coli
O157 method could detect
E. coli O157
in select foods as claimed by the
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manufacturer.
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The 3M MDA2 -
E. coli
O157 was evaluated following the AOAC Official Method
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requirements: inclusivity/exclusivity and method comparison. The 3M MDA2 -
E. coli
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O157 method was compared to the USDA/FSIS-MLG 5.09
Detection, Isolation and
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Identification of Escherichia coli
O157:H7
from Meat Products and Carcass and
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Environmental Sponges
for raw ground beef (325 g) and to FDA/BAM Chapter 4A
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Diarrheagenic Escherichia coli
for frozen blueberries (25 g), sprouts (25 g) and fresh
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baby spinach (200 g). Overall the assay was equivalent to the reference methods based
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on the Probability of Detection (POD) analysis.
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1.3
Study Director for Collaborative Study
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OMAMAN-35 B: Collaborative Study Protocol
ERP USE ONLY
January 2017
AOAC Research Institute
Expert Review Panel Use Only