ASCP, FDA Share Similar Concerns on Antigen Testing

ASCP recently wrote the Food and Drug Administration (FDA) raising concerns about antigen testing for COVID-19. In an April 29 letter, ASCP wrote, “The diminished sensitivity of these assays means that negative test results should be followed up with a confirmatory test, i.e., a COVID-19 RT-PCR assay.”  ASCP also requested that if COVID-19 antigen detection tests enter into the market, or if an Emergency Use Authorization (EUA) plan for antigen tests is developed, the FDA should include guidance concerning the appropriate use of these products. In response, an FDA official indicated that it shared these concerns, stating that clarity about the appropriate use of antigen testing is important to the Agency, given their performance characteristics.

Other articles in the May 2020 ePolicy News:

• New Law Includes Funding for COVID-19 Testing, ASCP Recommendations for Testing Strategy
• ASCP Urges Creation of National COVID-19 Testing Task Force
• AMA Endorses ASCP’s Call for a National Testing Strategy
• Governors, State Health Directors Hear from ASCP BOC about COVID-19 Response
• Hazard Pay, Mental Health Benefits Sought for Pathologists, Laboratory Professionals
• ASCP Interviewed about Job Satisfaction, Well-Being of Pathologists
• CMS Urged to Consider Specialists When Implementing MIPS Value Pathways
• Updated Risk-Based Guidelines Now Published for Management of Abnormal Results in Cervical Cancer Screening and Colposcopy

To read more articles from ePolicy News click here.

For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202) 408-1110.

ASCP ePolicy News is supported by an unrestricted grant from Hologic.