Sensitivity and Specificity of Rapid Antigen SARS-CoV-2 Tests Revealed

Strategic Insights -

A recent study from the University of Southern Denmark aimed to investigate the sensitivity and specificity of rapid antigen SARS-CoV-2 tests in preapproval and postapproval studies. Researchers analyzed 61 rapid antigen tests, identifying postapproval studies for 13 of them. The analysis incorporated 13 preapproval studies and 26 postapproval studies, involving a total of 591 patients with COVID-19 and 12,444 participants.

Key Takeaways:

  • The pooled sensitivity for preapproval and postapproval studies was 86.5% (95% CI: 83.3-89.1%) and 84.5% (95% CI: 81.2-87.3%), respectively.
  • The absolute difference in sensitivity between preapproval and postapproval studies was 2.0% (95% CI: -1.9% to 6.2%).
  • Two of the nine tests had lower sensitivity in postapproval studies, contradicting manufacturers' high estimates.
  • 79% of FDA-approved rapid antigen tests lacked postapproval studies, highlighting the need for ongoing evaluations.
  • Researchers concluded that sensitivity estimates from postapproval studies are largely consistent with manufacturers' estimates.

Statistics:

  • 61 rapid antigen tests were analyzed in the study.
  • 13 postapproval studies were identified, involving 2765 patients with COVID-19 and 12,444 participants.
  • The pooled sensitivity for preapproval studies was 86.5% (95% CI: 83.3-89.1%).
  • The pooled sensitivity for postapproval studies was 84.5% (95% CI: 81.2-87.3%).
  • The absolute difference in sensitivity between preapproval and postapproval studies was 2.0% (95% CI: -1.9% to 6.2%).

Sources:

  • University of Southern Denmark's study: "Preapproval and postapproval diagnostic test accuracy of food and drug administration-authorized rapid antigen SARS-CoV-2 tests used according to instruction: a systematic review and meta-analysis"
  • Clinical Microbiology and Infection journal: Elsevier Sci Ltd, 125 London Wall, London, England (onlinelibrary.wiley.com/journal/10.1111/(ISSN)1469-0691)
  • News editors from Politics & Government Week: NewsRx, LLC (Copyright 2025, NewsRx LLC)