Current regulatory landscape for viral point-of-care testing in the United States

J Clin Virol. 2023 Jul:164:105492. doi: 10.1016/j.jcv.2023.105492. Epub 2023 May 17.


Historically, the diagnosis of viral infections has been accomplished using a combination of laboratory-based methods, including culture, serology, antigen-based tests, and molecular (e.g., real-time PCR) assays. Although these methods provide an accurate way to detect viral pathogens, testing in a centralized laboratory may delay results, which could impact patient diagnosis and management. Point-of-care tests, including antigen- and molecular-based assays, have been developed to assist with the timely diagnosis of several viral infections, such as influenza, respiratory syncytial virus, and COVID-19. Despite the ability of point-of-care tests to provide rapid results (i.e., <30 min), there are issues to consider prior to their routine use, including test performance and specific regulatory requirements. This review will provide a summary of the regulatory landscape of point-of-care tests for viral infections in the United States, and address important considerations such as site certification, training and inspection readiness.

Keywords: Antigen tests; Molecular tests; Point-of-care testing; Regulations; Virology.

Publication types

  • Review

MeSH terms

  • COVID-19* / diagnosis
  • Humans
  • Molecular Diagnostic Techniques / methods
  • Point-of-Care Systems
  • Point-of-Care Testing
  • Respiratory Syncytial Virus, Human* / genetics
  • Sensitivity and Specificity
  • United States
  • Virus Diseases* / diagnosis