AOAC ERP MICRO AUGUST 2018

AOAC Official Methods Program  Expert Review Panel for Microbiology for Foods and Environmental Surfaces 

ER 5 ER 6 ER 1 ER 2 ER 3 ER 4 ER 5 ER 6 ER 1 ER 2 ER 3 ER 4 ER 5 ER 6

Yes Yes Yes No Yes Yes Yes No

Are there any reference materials considered or addressed?

Is there documentation regarding reference materials available and noted? If so, where is it located?

P. 469 Journal of AOAC International Vol. 100, No. 2, 2017 

NA

Inclusivity/exclusivity data is found in PTM 111501.

Reference Cultures Reference cultures

No. What type of single laboratory validations were used for this method [i.e, Harmonized PTM, Precollaborative, Independent, Collaborative,  etc.] and where is it referenced in the method documentation? harmonized AOAC Performance Tested MethodSM (PTM) and Official Methods of AnalysisSM study. The objective of the PTM study was to demonstrate that the 3M MDA 2 – Listeria monocytogenes method could detect L. monocytogenes in a variety of food matrixes and on select  environmental surfaces as claimed by the manufacturer 

ER 1

Collaborative.AOAC Official Method 2016.08 Listeria monocytogenes in a Variety of Foods and Select Environmental Surfaces 3M™ Molecular Detection Assay (MDA) 2– Listeria monocytogenes Method First Action 2016.

ER 2 ER 3 ER 4 ER 5

Harmonized PTM Harmonized PTM Harmonized PTM

Harmonized AOAC Performance Tested Method and Official Methods of Analysis study

ER 6

Are the approved validation protocols available and documented?

ER 1 ER 2 ER 3 ER 4 ER 5 ER 6 ER 1 ER 2 ER 3 ER 4 ER 5 ER 6 ER 1 ER 2 ER 3 ER 4 ER 5 ER 6

Yes Yes No Yes Yes

Yes Is the method documentation available that demonstrates Reproducibility/Uncertainty and Probability of Detection? If so, please cite the  reference.

STATISTICAL REVIEW: Is the documentation for the statistical review prior to AOAC First Action Official Methods status available and  completed?

yes yes Yes Yes

It was done, but the materials are not in the ERP packet.

Yes. Please cite below the OMA Appendicies, Community Guidance, or  SMPR by which this method was reviewed against.

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