Rabies test kit for humans

Regulation of diagnostic test kits

Recently, point-of-care diagnostic tests have become increasingly available to the public. Promising studies conducted in Africa, Asia, and the United States have found that certain point-of-care tests can demonstrate high sensitivity and specificity.

However, no point-of-care test for rabies has been rigorously validated and none are approved for use by USDA, CDC's National Rabies Reference Laboratory, WHO, or WOAH.

In general, if a given diagnostic product contains all materials needed to run a particular test, including instructions on the interpretation of results, and if the intent of the manufacturer is to provide a self-contained, point-of-care product, such an application, may be considered a diagnostic kit, and is under regulation by the United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Center for Veterinary Biologics.

More information is available at the Center for Veterinary Biologics website.