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Diagnostic Performance, User Acceptability, and Safety of Unsupervised SARS-CoV-2 Rapid Antigen Detecting Tests Performed at Home

20 Pages Posted: 30 Aug 2021

See all articles by Ida Johanne Borcher Møller

Ida Johanne Borcher Møller

Aarhus University - Department of Infectious Diseases

Amalie Rasmussen Utke

Aarhus University - Aarhus University Hospital

Ulla Kildall Ryesgaard

Aarhus University - Aarhus University Hospital

Lars Jørgen Østergaard

Aarhus University - Aarhus University Hospital

Sanne Jespersen

Aarhus University - Aarhus University Hospital

More...

Abstract

Background: One strategy for reducing the spread of coronavirus disease 2019 (COVID-19) is to contain the infection with broad screening, isolate infected individuals, and subsequently, trace any contacts. This strategy requires widely available, reliable testing for SARS-CoV-2. To increase testing, rapid antigen detection tests (RADTs) were developed for self-sampling, self-testing, and self-interpretation. The present study aimed to examine diagnostic performance, user acceptability, and safety of nasal self-RADTs, compared to standard PCR testing.

Methods: In this manufacturer-independent prospective study, we evaluated two different COVID-19 RADTs, made in Denmark and China, for use as unsupervised self-tests. Participants were recruited from an ambulatory public COVID-19 test center in Aarhus, Denmark. Self-RADT kits, including instructions, were distributed at the test center or delivered to participants. Participants reported test results and test preferences. During enrollment, participants reported the occurrence and duration of symptoms that were consistent with COVID-19. The sensitivity and specificity of each RADT, relative to PCR testing, were calculated.

Findings: Among 827 participants, 102 showed positive PCR test results. The sensitivities of the self-RADTs were 65·7% (95% CI: 49·2–79·2; Danish) and 62·1% (95% CI: 50·1–72·9; Chinese), and the specificities were 100% (95% CI: 99·0–100; Danish) and 100% (95% CI: 98·9–100; Chinese). The sensitivities of both self-RADTs were higher in symptomatic participants than in asymptomatic participants. Two out of every three participants preferred the self-RADT over the PCR test.

Interpretation: Self-performed RADTs were reliable, user acceptable, and safe among lay people as an alternative to professionally collected oropharyngeal PCR testing. 

Funding: None to declare.

Declaration of Interest: None to declare.

Ethical Approval: The regional Scientific Ethics Committee of the Central Denmark Region concluded that this quality assurance study did not require scientific ethical approval (reference number 1-10-72-1-20). The Danish Medicines Agency concluded that the study did not require approval from them.

Suggested Citation

Møller, Ida Johanne Borcher and Rasmussen Utke, Amalie and Kildall Ryesgaard, Ulla and Østergaard, Lars Jørgen and Jespersen, Sanne, Diagnostic Performance, User Acceptability, and Safety of Unsupervised SARS-CoV-2 Rapid Antigen Detecting Tests Performed at Home. Available at SSRN: https://ssrn.com/abstract=3908481 or http://dx.doi.org/10.2139/ssrn.3908481

Ida Johanne Borcher Møller (Contact Author)

Aarhus University - Department of Infectious Diseases ( email )

Aarhus
Denmark

Amalie Rasmussen Utke

Aarhus University - Aarhus University Hospital ( email )

Denmark

Ulla Kildall Ryesgaard

Aarhus University - Aarhus University Hospital ( email )

Denmark

Lars Jørgen Østergaard

Aarhus University - Aarhus University Hospital ( email )

Denmark

Sanne Jespersen

Aarhus University - Aarhus University Hospital ( email )

Denmark

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