| Title: |
Diagnostic accuracy of SARS-CoV-2 rapid antigen self-tests in asymptomatic individuals in the Omicron period:a cross-sectional study |
| Authors: |
Venekamp, Roderick P; Schuit, Ewoud; Hooft, Lotty; Veldhuijzen,Irene K; van den Bijllaardt,Wouter; Pas, Suzan D; Zwart,Vivian F; Lodder,Esther B; Hellwich,Marloes; Koppelman,Marco; Molenkamp,Richard; Wijers,Constantijn Jh; Vroom,Irene H; Smeets,Leonard C; Nagel-Imming,Carla R S; Han,Wanda G H; van den Hof,Susan; Kluytmans, Jan AJW; van de Wijgert, Janneke H M; Moons, Karel G M; HAG Onderzoek; Child Health; Infection & Immunity; JC onderzoeksprogramma Infectious Diseases; Epi Methoden Team 4; JC onderzoeksprogramma Methodology; Epidemiology & Health Economics; Medische Microbiologie; Epi Infectieziekten Team 1b; Epi Methoden; Cancer |
| Publication Year: |
2023 |
| Subject Terms: |
Asymptomatic individuals; Diagnostic accuracy; Rapid antigen tests; SARS-CoV-2; Microbiology (medical); Infectious Diseases; Journal Article |
| Description: |
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. |
| Document Type: |
article in journal/newspaper |
| File Description: |
text/plain |
| Language: |
English |
| ISSN: |
1198-743X |
| Relation: |
https://dspace.library.uu.nl/handle/1874/447514 |
| Availability: |
https://dspace.library.uu.nl/handle/1874/447514 |
| Rights: |
info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.49A3C5A8 |
| Database: |
BASE |