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1

Comparative Evaluation of the VIDAS®

Listeria

monocytogenes Express (LMX) for the Detection of

Listeria monocytogenes

in a

1

variety of foods: AOAC

Performance Tested Method

SM

MMYYNN

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Abstract

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The VIDAS®

Listeria

monocytogenes

Xpress (LMX) test is an enzyme-linked fluorescent immunoassay (ELFA) designed for use

6

with the automated VIDAS® or mini-VIDAS® instruments for the specific detection of

Listeria

monocytogenes

using a 26-hour

7

proprietary enrichment broth. The VIDAS LMX method was validated according to harmonized AOAC Research Institute (RI) and

8

Official Method of Analysis (OMA) guidelines in both the AOAC The

Performance Tested Method

SM

(PTM) and GovVal programs.

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In the PTM comparison studies, the VIDAS LMX method was compared to the USDA/FSIS MLG, FDA-BAM and AOAC Official

10

Methods. The comparative food studies consisted of two main parts: internal testing and AOAC independent laboratory testing, which

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included seven food matrices (deli-ham, processed cheese, vanilla ice cream, cooked shrimp, smoked white fish, frozen spinach and

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peanut butter). As part of the AOAC® Research Institute GovVal program, the VIDAS LMX method was compared to the Health

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Canada MFHPB-30 method for the detection of

Listeria monocytogenes

in five “ready to eat” (RTE) meats (hot dogs, deli turkey, deli

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ham, fermented sausage, and liver paté). Twenty replicates of each inoculation level and five uninoculated controls were evaluated in

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each study. The LSX method also included the use of chromogenic media, chromIDTM Ottaviani Agosti Agar (OAA) and

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chromIDTM Lmono, for confirmation of LMX presumptive results.

In both the PTM and GovVal evaluations there were no

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significant differences in the chi-square values for the LMX method when compared to reference methods. The additional parameters

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tested in the PTM evaluation (inclusivity, exclusivity, ruggedness, stability, and lot-to-lot) satisfied the AOAC RI performance

19

requirements. In both the PTM and GovVal validation studies the VIDAS LMX method demonstrated reliability as a rapid qualitative

20

method for the next day detection of

Listeria monocytogenes

in a variety of foods including RTE meats.

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Method Authors

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Ron Johnson and John Mills

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bioMérieux, Inc.

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595 Anglum Drive

27

Hazelwood, MO 63042

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USA

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Jean-Louis Pittet

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BioMerieux SA

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Chemin de l'Orme,

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69280 Marcy l'Etoile

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France

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PTM Certification Report