AOAC RI Completes GovVal Program: Validation of Listeria Test Kits
| The AOAC Research Institute has completed the review of Listeria species and Listeria monocytogenes test kit methods through the GovVal validation program in comparison to the Health Canada reference method for Listeria species and Listeria monocytogenes detection, MFHPB-30. |
Ten Listeria species and Listeria monocytogenes test kit methods from five method developers were submitted to the GovVal program; the test kit methods were validated against MFHPB-30. These test kit methods were previously certified Performance Tested MethodsSM (PTM) through comparisons to other reference methods, such as the U.S. FDA Bacteriological Analytical Manual (BAM) reference method, the USDA FSIS Microbiology Laboratory Guidebook (MLG) reference method, the AOAC OMA 993.12 or the ISO 11290 reference method for Listeria.
Click here to see which test methods went through the program.
Few of these test kit methods had been compared to the Health Canada reference method prior to this evaluation. Through the GovVal program, commercially rapid methods for Listeria detection that have demonstrated comparable or better performance when compared with the Health Canada MFHPB 30 reference method are now available.
The GovVal program is based on the PTM program operated by the AOAC Research Institute. Candidate test kit methods were evaluated using a validation protocol approved by AOAC, the Canadian Food Inspection Agency and Health Canada, using blind coded, randomized samples. Results were reviewed and approved by the AOAC General Referee's for Microbiology. Sample preparation and independent testing of many test kit methods, as well as the MFHPB-30 reference method, was done by an AOAC RI approved independent laboratory, Q Laboratories, Inc. (Cincinnati, Ohio).
The GovVal program also compared several international cultural methods to MFHPB-30, generating data in support of an equivalency determination for internationally accepted reference methods This is a critical step in creating harmonized methods validation protocols to streamline international regulatory submissions for new test kits.
Method developers are invited by HC and CFIA to submit the AOAC report, along with raw and summary data to Health Canada's Compendium of Analytical Methods at email@example.com. This data will be reviewed by the Microbiology Methods Committee (MMC) for consideration as acceptable methods for regulatory testing in Canada.
The GovVal program is designed to evaluate previously AOAC-approved methods for the specific needs of regulatory agencies to enforce their standards for regulatory testing, in this case Listeria monocytogenes in ready-to-eat meats and Listeria species on stainless steel surfaces as compared to the Health Canada reference method.
For an up-to-date list of PTMs, visit www.aoac.org/testkits/testedmethods.html.
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Posted: October 18, 2011
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