“They all did a fine job, but without agreed-upon standards to validate equivalency of results between the different labs, it was possible the interpretation of test results could vary among labs. “To their credit, veterinary diagnostic laboratories quickly started developing tests to detect PEDv,” said Akey. For example, several years ago when porcine epidemic diarrhea virus (PEDv) was discovered in the United States, one challenge was to develop a test that could identify the exact virus and then reliably find it. These guidelines are particularly important when working with emerging diseases. “Many laboratories now are making a great effort to base new assays on these guidelines, completing extensive documentation to validate results.” “Previous methods used to validate new diagnostic tests varied widely across the country and throughout the world,” said Johnny Callahan, Ph.D., a senior consultant with Thermo Fisher Scientific, a company with deep expertise in animal diagnostics. Relatively new guidelines developed by the AAVLD have given member laboratories a process to follow, and specific criteria for validating and documenting development of new assays. Department of Agriculture (USDA)-approved diagnostics have built-in standardization, but additional steps must be taken to validate and verify results of the other diagnostic tests developed by individual laboratories.” Guidelines for new diagnostics Bruce Akey, a veterinarian and director of the Texas A&M Veterinary Medical Diagnostic Laboratory. “Diagnostic standards are in place for state and federal regulatory testing, but that represents only a small fraction of the testing done in diagnostic laboratories,” said Dr. They agreed that having standards at each stage of the diagnostic process - from on-farm sample collection to laboratory testing and the interpretation of results - is the best foundation for providing diagnostic results veterinarians and livestock producers can trust time after time.
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