AOAC Performance Tested Method program

AOAC Research Institute Performance Tested Methods Program Policies and Procedures, AOAC Research Institute, Gaithersburg, MD, 2009 (available at http //www. 

The AOAC Performance-Testing Program is designed essentially for test kits, to provide third-party verification of performance claims for commercial, proprietary test kit analytical methods. Operation of this program is under the AOAC Research Institute, a subsidiary of AOAC INTERNATIONAL. 

The AOAC PVM program is intended to provide a class of tested methods that have not been the subject of a full collaborative study. Through a less intensive process, the program provides a rapid enuy point for method,s that arc recognized by the AOAC at a level of validation for methods not otherwise evaluated. The distinguishing aspect of an AOAC PVM is that its performance has been checked in at least one other independent laboratory. It is expected that eventually most PVMs will undergo full interlaboratory collaborative studies and obtain OMA status. 

The mouse bioassay (MBA) was developed 70 years ago by Sommer and Meyer as part of their pioneering work that related the dinoflagellate Alexandrium catenella (Gonyaulax) as a causative agent of PSP (see Wekell et al ). At the time, the identity of the paralyzing toxic compounds was not known and the MBA remained for several years as a field test to help health officials manage toxic outbreaks in Alaska and British Columbia.Only after a purified saxitoxin dihydrochloride was made available in 1950 was it possible to calibrate the assay, and the AOAC accepted the new version of the MBA as an official method. Reasons for the sustained application of the MBA lie in its simplicity of application, relatively low cost, and availability of test protocols to calibrate mice strains to compare operator performance and to perform repeatability and reproducibility studies (National Shellfish Sanitation Program, USA ). 

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