Acquisition of Filovirus Point-of-Care (PoC) Diagnostic Tests
Closed Solicitation Posted
- Solicitation number
- 75A50122Q00017
- Agency
-
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325413 In-Vitro Diagnostic Substance Manufacturing
- Place of performance
- Bethlehem, Pennsylvania 18015, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Biomedical Advanced Research and Development Authority (BARDA), an agency of the Department of Health and Human Services (HHS), seeks to procure point-of-care diagnostic tests for Ebola virus. The solicitation requires handheld, lateral flow, rapid antigen tests that are FDA authorized or cleared to sample oral fluid from cadavers and test individuals suspected to have recently died from Ebola virus disease. Responses are due by May 24, 2022 and award will be made to the technically acceptable offeror with the lowest price.
The solicitation does not include any set-aside designations. The NAICS code is 541715 and PSC code is 6515. OraSure Technologies is identified as the only contractor that can meet all requirements. BARDA seeks to procure a minimum of 8,500 diagnostic tests from OraSure, with delivery to the Centers for Disease Control and Prevention within 90 days of order. The potential value is undetermined, but the contract would have a 60 month period of performance and include options to purchase additional lots of tests over five years. The place of performance is Fountain Hill, Pennsylvania.
Notice text
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.
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