High Performance Antigen Diagnostics

The Administration for Strategic Preparedness and Response (ASPR), through the Biomedical Advanced Research and Development Authority (BARDA) and the Department of Health and Human Services, is issuing a Request for Information (RFI) under solicitation number RRPV-HPAD to explore advancements in high-performance antigen diagnostics for near-patient use. The goal is to identify innovative immunoassay technologies capable of bridging the sensitivity gap between conventional antigen tests and nucleic acid amplification tests (NAATs), with a target analytical sensitivity of 1–10 pg/mL or better. Respondents are expected to describe platforms that can deliver ultra-sensitive antigen detection in compact, rapid, and ideally multiplexed formats suited for point-of-care or at-home settings, including CLIA-waived environments. Submissions must detail the full workflow—from sample input and processing to detection methods and readout—along with signal amplification strategies, sample concentration techniques, and the current technology maturity level using established TRL frameworks. A clear path for scaling production of reagents, devices, and consumables, including supply chain considerations, is required, while submissions focused solely on antibody or molecular binder development are outside the scope. Responses are due by 1:00 PM EDT on July 17, 2026, and must be submitted via email to rrpv@ati.org in PDF or Word format, adhering to strict page limits: a 0.5-page executive summary, a 4-page technical overview, a 0.5-page capabilities and infrastructure section, and a cover page with organizational and contact details. The total technical response must not exceed five pages, with font no smaller than 10-point. No classified information should be included, and all proprietary or confidential materials must be clearly marked with appropriate legends. While participation in the Rapid Response Partnership Vehicle (RRPV) consortium is not required for this RFI, it is mandatory for any future project proposal solicitation. This RFI is purely for market research and does not constitute a solicitation for proposals or any binding obligation to issue a future contract. The NAICS code is 541714, no set-aside applies, and responses will be treated as sensitive information. There is no estimated contract value, no formal evaluation factors, and no procurement action is imminent.