Diagnostic accuracy of a SARS-CoV-2 rapid antigen test in real-life clinical settings.
Int J Infect Dis
; 109: 118-122, 2021 Aug.
Article
em En
| MEDLINE
| ID: mdl-34242764
ABSTRACT
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:
The aim of this study was to assess the accuracy of a rapid antigen test in diagnosing SARS-CoV-2 infection in a primary/secondary care testing facility.METHODS:
Consecutive individuals presenting at a COVID-19 testing facility affiliated to a Swiss University Hospital were recruited (n = 1465%). Nasopharyngeal swabs were obtained, and the Roche/SD Biosensor rapid antigen test was conducted in parallel with two real-time PCR tests (reference standard).RESULTS:
Among the 1465 patients recruited, RT-PCR was positive in 141 individuals, corresponding to a prevalence of 9.6%. The Roche/SD Biosensor rapid antigen test was positive in 94 patients (6.4%), and negative in 1368 individuals (93.4%; insufficient sample material in 3 patients). 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 accuracy of the SARS-CoV-2 Roche/SD Biosensor rapid antigen test in diagnosing SARS-CoV-2 infections in a primary/secondary care testing facility was considerably lower compared with the manufacturer's data. Widespread application in such a setting might lead to a considerable number of individuals falsely classified as SARS-CoV-2 negative.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
SARS-CoV-2
/
COVID-19
Tipo de estudo:
Diagnostic_studies
/
Risk_factors_studies
Limite:
Humans
Idioma:
En
Revista:
Int J Infect Dis
Assunto da revista:
DOENCAS TRANSMISSIVEIS
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Suíça