Considerations for Assessment and Deployment of Rapid Antigen Tests for Diagnosis of Coronavirus Disease 2019. (7th March 2021)

• Record Type: Journal Article
• Authors: Pollock, Nira R; Lee, Francesca; Ginocchio, Christine C; Yao, Joseph D; Humphries, Romney M
• Is Part Of: Open forum infectious diseases. Volume 8:Number 6(2021)
• Publication Date: 2021-03-07
• Subjects: antigen -- COVID -- diagnostic -- point-of-care -- SARS-CoV-2; Communicable diseases -- Periodicals; Medical microbiology -- Periodicals; Infection -- Periodicals; 616.9
• DOI: 10.1093/ofid/ofab110
• Languages: English
• ISSNs: 2328-8957

Abstract

Abstract: Diagnostic testing is a critical tool to mitigate the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, but molecular testing capacity remains limited. Rapid diagnostic tests (RDTs) that detect SARS-CoV-2 protein antigens (Ag) offer the potential to substantially expand testing capacity and to allow frequent, large-scale, population screening. Testing is simple, rapid (results generally available within 15 minutes), and applicable for diagnosis at point of care. However, implementation of Ag RDTs requires a detailed understanding of test performance and operational characteristics in each testing scenario and population being evaluated. Successful implementation of Ag RDTs on a large scale should combine testing with technical oversight and with clinical and public health infrastructure, and will require production at levels much higher than presently possible. In this commentary, we provide detailed considerations for Ag RDT assessment and use cases to encourage and enable broader manufacturing and deployment. Abstract : Rapid diagnostic tests (RDTs) detecting SARS-CoV-2 protein antigens (Ag) offer the potential to substantially expand pandemic testing capacity. In this commentary, we provide detailed considerations for Ag RDT assessment and use cases to encourage and enable broader manufacturing and deployment.