The Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS) seeks to purchase diagnostic tests for Ebola virus. The test must be a point of care, handheld, lateral flow, rapid antigen test for Ebola virus that is either emergency use authorized or 510(k) cleared by the U.S. Food and Drug Administration. The test sample type must be oral fluid from cadavers. The test must be for use on individuals suspected to have recently died from the Ebola virus disease.

OraSure Technologies is uniquely qualified because their product is the only test that meets all the following salient characteristics:

• For point of care use
• Handheld
• Lateral flow, rapid antigen test for Ebola virus
• Either emergency use authorized, or Section 510(k) cleared by the U.S. Food and Drug Administration (FDA)
• Samples oral fluid from cadavers
• For use on individuals or suspected to have recently died from the Ebola virus disease
• Nine (9) month shelf life from date of delivery

Alternative tests will not work because the Government will be unable to assess infection with the Ebola Virus in individuals and cadavers.  The inability to assess infections would jeopardize HHS’ public health mission in a way that would result in unacceptable risks to the health of the public.