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This paper provides general and specific guidance for the development and implementation of a quality assurance program for Ames testing. An effective quality assurance program is needed to assure that data produced from short-term mutagenicity testing (e.g., the Ames test) are of known quality and comparable among laboratories conducting the testing. The success of such a program begins with a personal and organizational commitment to data quality. Next, standardized procedures for the conduct and control of the testing process should be adopted and rigidly followed. Finally, participation in an external quality assurance program is necessary for independent confirmation of testing performance and confirmation of interlaboratory data comparability. Comparability of test data is required if there is to be confidence in the results of testing activities and acceptance of the resulting interpretation of test findings.
Detailed quality control procedures are outlined for the Ames test. These include procedures for confirming the genotype and responsiveness of tester strains, confirming the absence of bacterial contamination, providing appropriate positive and negative test controls, confirming the enzymatic activity of metabolic activators, and determining the adequacy of test data.
The functions and responsibilities of an effective quality assurance program are outlined. Primary functions include development of standards based upon technically attainable criteria, assistance to participating laboratories in adopting those standards, and independent evaluation of the success of the laboratories in meeting those standards.
Ames test, Salmonella, quality assurance, quality control, mutagenicity, method standardization, data quality, mutagen, test method
Manager, Biological QA Program, Quality Assurance Division, Environmental Monitoring Systems Laboratory, U.S. Environmental Protection Agency, Las Vegas, NV