Scaling up COVID-19 rapid antigen tests: promises and challenges
- PMID: 33636148
- PMCID: PMC7906660
- DOI: 10.1016/S1473-3099(21)00048-7
Scaling up COVID-19 rapid antigen tests: promises and challenges
Abstract
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.
Copyright © 2021 Elsevier Ltd. All rights reserved.
Comment in
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SARS-CoV-2 rapid antigen detection tests.Lancet Infect Dis. 2021 Aug;21(8):1067-1068. doi: 10.1016/S1473-3099(21)00249-8. Epub 2021 May 4. Lancet Infect Dis. 2021. PMID: 33961799 Free PMC article. No abstract available.
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SARS-CoV-2 rapid antigen detection tests.Lancet Infect Dis. 2021 Aug;21(8):1068-1069. doi: 10.1016/S1473-3099(21)00206-1. Epub 2021 May 4. Lancet Infect Dis. 2021. PMID: 33961800 Free PMC article. No abstract available.
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SARS-CoV-2 rapid antigen detection tests - Authors' reply.Lancet Infect Dis. 2021 Aug;21(8):1069-1070. doi: 10.1016/S1473-3099(21)00250-4. Epub 2021 May 4. Lancet Infect Dis. 2021. PMID: 33961801 Free PMC article. No abstract available.
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References
-
- WHO Director general's opening remarks at the March 16, 2020 media briefing. March 16, 2020. https://www.who.int/director-general/speeches/detail/who-director-genera...
-
- FIND FIND evaluations of SARS-CoV-2 assays. 2020. https://www.finddx.org/covid-19/sarscov2-eval/
-
- US Food and Drug Administration Emergency use authorizations for medical devices. July 29, 2020. https://www.fda.gov/medical-devices/emergency-situations-medical-devices...
-
- WHO Emergency use listing procedure for in vitro diagnostics. Jan 8, 2020. https://www.who.int/teams/regulation-prequalification/eul/in-vitro-emerg...
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