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Study Report Authors

Kiel Fisher, Benjamin Bastin, Jonathan Flannery, Allison Mastalerz, Patrick Bird,Erin

Crowley, M. Joseph Benzinger Jr., James Agin, David Goins

Q Laboratories, Inc., Cincinnati, OH 45214 USA

Method Authors

Marcia Armstrong, Kathrin Wolf, Sandra Luleyand Ralf Peist

Submitting Company

QIAGEN GmbH

QIAGEN Str. 1

40724 Hilden, Germany

Phone: +49-2103 292-0 (Germany)

Phone: 800-426-8157 (USA)

Fax: 800-718-2056 (USA)

Website:

www.qiagen.com

(worldwide)

Independent Laboratory

Q Laboratories, Inc., Cincinnati, OH 45214 USA.

Reviewers

Yi Chen, US FDA Center for Food Safety and Nutrition

Elliot Ryser, Michigan State University

Yvonne Salfinger, Retired, Florida Department of Agriculture and Consumer Services

Scope of Method

(a)

Target organisms - E.coli O157 and E.coli non-O157 STECs(O26, O45,O103,

O111, O121, O145).

The

mericon

E. coli O157 Screen Plus Assay screens for

the presence of virulence factors

stx1/stx2, eae

andO157 while the

mericon

E.coliSTEC O-Type Assay detects the pathogenic STEC O-types

(O26, O45, O103, O111, O121, O145) or O157:H7.

(b)

Matrixes

1) Fresh spinach (25 g test portions)

2) Raw ground beef (70% lean) (325 g test portions)

3) Raw beef trim (325 g test portions)

(c)

Summary of validated performance claims

OMAMAN-36 E/ AOAC PTM Report

ERP Use Only

January 2017

AOAC Research Institute

Expert Review Panel Use Only