Scaling up COVID-19 rapid antigen tests: promises and challenges

Lancet Infect Dis. 2021 Sep;21(9):e290-e295. doi: 10.1016/S1473-3099(21)00048-7. Epub 2021 Feb 23.


WHO recommends a minimum of 80% sensitivity and 97% specificity for antigen-detection rapid diagnostic tests (Ag-RDTs), which can be used for patients with symptoms consistent with COVID-19. However, after the acute phase when viral load decreases, use of Ag-RDTs might lead to high rates of false negatives, suggesting that the tests should be replaced by a combination of molecular and serological tests. When the likelihood of having COVID-19 is low, such as for asymptomatic individuals in low prevalence settings, for travel, return to schools, workplaces, and mass gatherings, Ag-RDTs with high negative predictive values can be used with confidence to rule out infection. For those who test positive in low prevalence settings, the high false positive rate means that mitigation strategies, such as molecular testing to confirm positive results, are needed. Ag-RDTs, when used appropriately, are promising tools for scaling up testing and ensuring that patient management and public health measures can be implemented without delay.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • COVID-19 / diagnosis*
  • COVID-19 Testing / methods*
  • COVID-19 Testing / standards*
  • False Negative Reactions
  • False Positive Reactions
  • Humans
  • Predictive Value of Tests
  • SARS-CoV-2*
  • Sensitivity and Specificity