Diagnostic accuracy of a SARS-CoV-2 rapid antigen test in real-life clinical settings.
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BORIS DOI
Publisher DOI
PubMed ID
34242764
Description
BACKGROUND
Laboratory tests are a mainstay in managing the COVID-19 pandemic, and high hopes are placed on rapid antigen tests. However, the accuracy of rapid antigen tests in real-life clinical settings is unclear because adequately designed diagnostic accuracy studies are essentially lacking.
OBJECTIVES
We aimed to assess the diagnostic accuracy of a rapid antigen test to diagnose SARS-CoV-2 infection in a primary/ secondary care testing facility.
METHODS
Consecutive individuals presented at a COVID-19 testing facility affiliated to a Swiss University Hospital were recruited (n=1'465%). Nasopharyngeal swabs were obtained, and the Roche/ SD Biosensor rapid antigen test was conducted in-parallel with two real-time PCR (reference standard).
RESULTS
Among 1'465 patients recruited, RT-PCR was positive in 141 individuals, corresponding to a prevalence of prevalence 9.6%. The Roche/ SD Biosensor rapid antigen test was positive in 94 patients (6.4%), and negative in 1'368 individuals (93.4%). The overall sensitivity of the rapid antigen test was 65.3% (95% confidence interval, CI, 56.8, 73.1), the specificity was 99.9% (95%CI 99.5, 100.0). In asymptomatic individuals, the sensitivity was 44.0% (95%CI 24.4, 65.1).
CONCLUSIONS
The diagnostic accuracy of the SARS-CoV-2 Roche/SD Biosensor rapid antigen test to diagnose a SARS-CoV-2 infection in a primary/ secondary care testing facility was considerably lower compared to manufacturers' data. Widespread application in this setting might lead to a considerable number of individuals falsely classified as SARS-CoV-2 negative.
Laboratory tests are a mainstay in managing the COVID-19 pandemic, and high hopes are placed on rapid antigen tests. However, the accuracy of rapid antigen tests in real-life clinical settings is unclear because adequately designed diagnostic accuracy studies are essentially lacking.
OBJECTIVES
We aimed to assess the diagnostic accuracy of a rapid antigen test to diagnose SARS-CoV-2 infection in a primary/ secondary care testing facility.
METHODS
Consecutive individuals presented at a COVID-19 testing facility affiliated to a Swiss University Hospital were recruited (n=1'465%). Nasopharyngeal swabs were obtained, and the Roche/ SD Biosensor rapid antigen test was conducted in-parallel with two real-time PCR (reference standard).
RESULTS
Among 1'465 patients recruited, RT-PCR was positive in 141 individuals, corresponding to a prevalence of prevalence 9.6%. The Roche/ SD Biosensor rapid antigen test was positive in 94 patients (6.4%), and negative in 1'368 individuals (93.4%). The overall sensitivity of the rapid antigen test was 65.3% (95% confidence interval, CI, 56.8, 73.1), the specificity was 99.9% (95%CI 99.5, 100.0). In asymptomatic individuals, the sensitivity was 44.0% (95%CI 24.4, 65.1).
CONCLUSIONS
The diagnostic accuracy of the SARS-CoV-2 Roche/SD Biosensor rapid antigen test to diagnose a SARS-CoV-2 infection in a primary/ secondary care testing facility was considerably lower compared to manufacturers' data. Widespread application in this setting might lead to a considerable number of individuals falsely classified as SARS-CoV-2 negative.
Date of Publication
2021-08
Publication Type
Article
Subject(s)
600 - Technology::610 - Medicine & health
500 - Science::570 - Life sciences; biology
Keyword(s)
COVID-19 diagnostic testing [Supplementary Concept] Infections/*epidemiology/transmission severe acute respiratory syndrome coronavirus 2 [Supplementary Concept]
Language(s)
en
Contributor(s)
Additional Credits
Universitätsinstitut für Klinische Chemie (UKC)
Universitäres Notfallzentrum
Institut für Infektionskrankheiten (IFIK)
Universitätsklinik für Infektiologie
Institut für Infektionskrankheiten, Klinische Mikrobiologie
Series
International journal of infectious diseases
Publisher
Elsevier
ISSN
1201-9712
Access(Rights)
open.access