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AOAC EXPERT REVIEW PANEL FOR MICROBIOLOGY FOR FOODS AND ENVIRONMENTAL SURFACES

AOAC Expert Review Panel Final Action Feedback

o All safety concerns identified during the 2-year evaluation period must be addressed.

o Guidance and support can be obtained from the AOAC Safety Committee.

Safety committee approved this method before the collaborative study was initiated. Microbiological

safety precautions are addressed in the OMA manuscript and in the method package insert, both of

which were reviewed and approved by the AOAC reviewers.

REFERENCE MATERIALS

o Document efforts undertaken to locate reference materials. Methods may still progress to Final Action

even if reference materials are not available. NA

SINGLE-LABORATORY VALIDATION

o Data demonstrating response linearity, accuracy, repeatability, LOD/LOQ, and matrix scope must be

present. Experimental designs to collect this data may vary with the method protocol and the intended

use of the method. This method was independently validated by AOAC RI, AOAC OMA and AFNOR

involving both single multi-laboratory evaluations and meeting statistical acceptance criteria for each

validation organization.

o Resources can be identified by the AOAC Statistics Committee.

NA

REPRODUCIBILITY/UNCERTAINTY AND PROBABILITY OF DETECTION

o Do you have any information that supports regarding the reproducibility of this method as written? If

so, please specify and submit information. This method was independently validated by AOAC RI, AOAC

OMA and AFNOR involving both single and multi-laboratory evaluations and meeting the statistical

acceptance criteria for approval from each validation organization.

ADDITIONAL FEEDBACK FROM USERS OF METHOD

o Based on your experience with the method, are there any recommended changes to the AOAC First

Action method as written? no

o Document positive and negative feedback from users of the method during the trial period regarding

the apparatus and reagents, general instructions, enrichment, results and interpretation, confirmation,

etc. see below

o Feedback from users demonstrating method ruggedness should be documented.

o Access to the future availability of vital equipment, reference materials, and supplies.

VIDAS® LMX is a proprietary bioMérieux test kit that is commercially available worldwide. The VIDAS®

VIDAS®

Listeria monocytogenes

Xpress (LMX) method is for use on the automated VIDAS instrument for

the next day detection of

Listeria monocytogenes

in foods using the ELFA method (Enzyme Linked

Fluorescent Assay). VIDAS LMX has received independent 3rd party approvals from AOAC RI, AOAC

OMA and AFNOR demonstrating reproducibility, repeatability, robustness and overall reliability in single

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