Diagnostic accuracy of a SARS-CoV-2 rapid antigen test in real-life clinical settings.

Jegerlehner, Sabrina; Suter-Riniker, Franziska; Jent, Philipp; Bittel, Pascal; Nagler, Michael (2021). Diagnostic accuracy of a SARS-CoV-2 rapid antigen test in real-life clinical settings. International journal of infectious diseases, 109, pp. 118-122. Elsevier 10.1016/j.ijid.2021.07.010

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Institute of Clinical Chemistry
04 Faculty of Medicine > Service Sector > Institute for Infectious Diseases > Clinical Microbiology
04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Infectiology
04 Faculty of Medicine > Service Sector > Institute for Infectious Diseases
04 Faculty of Medicine > Department of Intensive Care, Emergency Medicine and Anaesthesiology (DINA) > University Emergency Center

UniBE Contributor:

Jegerlehner, Sabrina; Suter, Franziska Marta; Jent, Philipp; Bittel, Pascal and Nagler, Michael

Subjects:

600 Technology > 610 Medicine & health
500 Science > 570 Life sciences; biology

ISSN:

1201-9712

Publisher:

Elsevier

Language:

English

Submitter:

Karin Balmer

Date Deposited:

16 Nov 2021 10:37

Last Modified:

16 Nov 2021 10:37

Publisher DOI:

10.1016/j.ijid.2021.07.010

PubMed ID:

34242764

Uncontrolled Keywords:

COVID-19 diagnostic testing [Supplementary Concept] Infections/*epidemiology/transmission severe acute respiratory syndrome coronavirus 2 [Supplementary Concept]

BORIS DOI:

10.48350/157624

URI:

https://boris.unibe.ch/id/eprint/157624

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