Diagnostic accuracy of a SARS-CoV-2 rapid antigen test in real-life clinical settings.
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BORIS DOI
Date of Publication
August 2021
Publication Type
Article
Author
Series
International journal of infectious diseases
ISSN or ISBN (if monograph)
1201-9712
Publisher
Elsevier
Language
English
Publisher DOI
PubMed ID
34242764
Uncontrolled Keywords
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.
File(s)
| File | File Type | Format | Size | License | Publisher/Copright statement | Content | |
|---|---|---|---|---|---|---|---|
| Diagnostic_accuracy.pdf | Adobe PDF | 1.09 MB | published |