Development and Implementation of COVID-19 Immune Assay(s) Development and Implementation
Awarded Limited / Sole Source Justification Posted
- Solicitation number
- BARDA-IEIDD-063025
- Agency
- Office of the Assistant Secretary for Preparedness and Response Department of Health and Human Services
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- 75A50123C00045 Federal contract award
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Place of performance
- North Carolina 28401, United States
- Points of contact
-
- Jill Johnson jill.johnson@hhs.gov (202) 816-1148
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response published this Limited/Sole Source Justification Notice for the development and implementation of COVID-19 immune assays to establish central laboratory capacity for analyzing mucosal and serum samples from USG-sponsored vaccine trials. The procurement specifically aims to utilize validated virus neutralization and binding assays to support COVID-19 vaccine studies, with program goals including establishing validated assays for SARS-CoV-2 emerging variants and testing serum samples from clinical trial subjects in compliance with GCLP guidelines. Contract 75A50123C00045 was awarded on September 29, 2023, though both the vendor identity and contract value remain undisclosed in the notice. The justification for the limited source approach appears to be based on the specialized nature of the laboratory capacity requirements and the need for validated assay capabilities for emerging COVID-19 variants. This research and development contract falls under NAICS code 541715 for Physical, Engineering, and Life Sciences R&D services and supports ongoing federal COVID-19 vaccine development efforts through centralized laboratory testing services.
Notice text
This procurement is aimed at providing a central laboratory capacity site for analysis of mucosal and serum samples collected from subjects enrolled in multiple USG-sponsored COVID-19 vaccine trials. This action covers efforts to utilize the validated virus neutralization (VN) and binding assays to support these studies. The program goals are:
1. Establish validated VN and binding assays for SARS-CoV-2 emerging variant(s).
2. Test serum samples from human subjects enrolled in clinical trials of COVID-19 vaccine candidates in variant VN and binding antibody assays in compliance with GCLP guidelines.
Awarded contract 75A50123C00045 to unknown vendor for unknown amount on 2023-09-29.
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