Diagnostic accuracy of SARS-CoV-2 rapid antigen self-tests in asymptomatic individuals in the omicron period: a cross-sectional study

Roderick P. Venekamp, Ewoud Schuit, Lotty Hooft, Irene K. Veldhuijzen, Wouter van den Bijllaardt, Suzan D. Pas, Vivian F. Zwart, Esther B. Lodder, Marloes Hellwich, Marco Koppelman, Richard Molenkamp, Constantijn J.H. Wijers, Irene H. Vroom, Leonard C. Smeets, Carla R.S. Nagel-Imming, Wanda G.H. Han, Susan van den Hof, Jan A.J.W. Kluytmans, Janneke H.H.M. van de Wijgert, Karel G.M. Moons*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Objectives: To assess the performances of three commonly used antigen rapid diagnostic tests used as self-tests in asymptomatic individuals in the Omicron period. Methods: We performed a cross-sectional diagnostic test accuracy study in the Omicron period in three public health service COVID-19 test sites in the Netherlands, including 3600 asymptomatic individuals aged ≥ 16 years presenting for SARS-CoV-2 testing for any reason except confirmatory testing after a positive self-test. Participants were sampled for RT-PCR (reference test) and received one self-test (either Acon Flowflex [Flowflex], MP Biomedicals (MPBio), or Siemens-Healthineers CLINITEST [CLINITEST]) to perform unsupervised at home. Diagnostic accuracies of each self-test were calculated. Results: Overall sensitivities were 27.5% (95% CI, 21.3–34.3%) for Flowflex, 20.9% (13.9–29.4%) for MPBio, and 25.6% (19.1–33.1%) for CLINITEST. After applying a viral load cut-off (≥5.2 log10 SARS-CoV-2 E-gene copies/mL), sensitivities increased to 48.3% (37.6–59.2%), 37.8% (22.5–55.2%), and 40.0% (29.5–51.2%), respectively. Specificities were >99% for all tests in most analyses. Discussion: The sensitivities of three commonly used SARS-CoV-2 antigen rapid diagnostic tests when used as self-tests in asymptomatic individuals in the Omicron period were very low. Antigen rapid diagnostic test self-testing in asymptomatic individuals may only detect a minority of infections at that point in time. Repeated self-testing in case of a negative self-test is advocated to improve the diagnostic yield, and individuals should be advised to re-test when symptoms develop.

Original languageEnglish
Pages (from-to)391.e1-391.e7
JournalClinical Microbiology and Infection
Volume29
Issue number3
Early online date12 Nov 2022
DOIs
Publication statusPublished - Mar 2023

Bibliographical note

Funding Information:
This research was supported from the Dutch Ministry of Health , Welfare, and Sport. The funder had no role in the design; collection, analysis, and interpretation of data; writing and decision to submit the paper for publication.

Publisher Copyright:
© 2022 The Author(s)

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