Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
The FDA has updated the comprehensive list of donor screening assays for infectious agents and HIV diagnostic assays. The provided tables include technical details such as tradenames, manufacturer information, specimen types, approval dates, and Submission Tracking Numbers (STNs).
This update affects manufacturers of infectious disease diagnostic assays, blood and tissue establishment operators, and regulatory professionals responsible for ensuring the compliance of donor screening protocols.
The availability of a consolidated, detailed list of approved assays suggests that the FDA is prioritizing transparency regarding the validated scope of diagnostic tools. For industry, this serves as a critical reference point for ensuring that screening processes use currently approved versions of assays (identified by STN) and adhere to the validated specimen formats and uses. Failure to align with these approved parameters could lead to compliance gaps in donor eligibility determinations or product safety protocols.
Regulatory and QA teams should verify that currently utilized donor screening and HIV diagnostic assays match the STN and approved uses listed in the updated FDA tables. Clinical operations and laboratory managers should cross-reference internal protocols against the validated specimen types and formats specified in the database.
Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN.
Open in openFDA / FDA.gov