DEVELOPING VALIDATION CRITERIA THAT MEET OR EXCEED INTERNATIONAL STANDARDS

摘要

The Animal Plant Health Inspection Service of the USDAis working in conjunction with the Agriculture Research Service of the USDA, academic institutions, and industry to validate rapid diagnostic tests for 8 diseases (Foot and Moutrr Disease, Classical Swine Fever, Avian Influenza, Newcastle Disease, African Swine Fever, Rinderpest, Lumpy Skin Disease, and Contagious Bovine Pleuropneumonia). A committee was formed to review test validation reference materials and determine acceptable validation criteria. Criteria were determined and will be used to validate the rapid assays for Foot and Mouth Disease and Classical Swine Fever. The criteria will also be used to review the data collected on the real time PGR during the 2002 Avian Influenza outbreak. When those processes are complete, the comments of those involved in test development and validation will be used to revise the validation criteria. The criteria detail the requirements necessary for bench development and field validation.