Schuit, Ewoud, Veldhuijzen, Irene K, Venekamp, Roderick P, van den Bijllaardt, Wouter, Pas, Suzan D, Lodder, Esther B, Molenkamp, Richard, GeurtsvanKessel, Corine H, Velzing, Jans, Huisman, Robin C et al (show 8 more authors)
(2021)
Diagnostic accuracy of rapid antigen tests in asymptomatic and presymptomatic close contacts of individuals with confirmed SARS-CoV-2 infection: cross sectional study.
BMJ-BRITISH MEDICAL JOURNAL, 374.
n1676-.
Abstract
<h4>Objective</h4>To assess the diagnostic test accuracy of two rapid antigen tests in asymptomatic and presymptomatic close contacts of people with SARS-CoV-2 infection on day 5 after exposure.<h4>Design</h4>Prospective cross sectional study.<h4>Setting</h4>Four public health service covid-19 test sites in the Netherlands.<h4>Participants</h4>4274 consecutively included close contacts (identified through test-and-trace programme or contact tracing app) aged 16 years or older and asymptomatic for covid-19 when requesting a test.<h4>Main outcome measures</h4>Sensitivity, specificity, and positive and negative predictive values of Veritor System (Beckton Dickinson) and Biosensor (Roche Diagnostics) rapid antigen tests, with reverse-transcriptase polymerase chain reaction (RT-PCR) testing as reference standard. The viral load cut-off above which 95% of people with a positive RT-PCR test result were virus culture positive was used as a proxy of infectiousness.<h4>Results</h4>Of 2678 participants tested with Veritor, 233 (8.7%) had a RT-PCR confirmed SARS-CoV-2 infection of whom 149 were also detected by the rapid antigen test (sensitivity 63.9%, 95% confidence interval 57.4% to 70.1%). Of 1596 participants tested with Biosensor, 132 (8.3%) had a RT-PCR confirmed SARS-CoV-2 infection of whom 83 were detected by the rapid antigen test (sensitivity 62.9%, 54.0% to 71.1%). In those who were still asymptomatic at the time of sampling, sensitivity was 58.7% (51.1% to 66.0%) for Veritor (n=2317) and 59.4% (49.2% to 69.1%) for Biosensor (n=1414), and in those who developed symptoms were 84.2% (68.7% to 94.0%; n=219) for Veritor and 73.3% (54.1% to 87.7%; n=158) for Biosensor. When a viral load cut-off was applied for infectiouness (≥5.2 log10 SARS-CoV-2 E gene copies/mL), the overall sensitivity was 90.1% (84.2% to 94.4%) for Veritor and 86.8% (78.1% to 93.0%) for Biosensor, and 88.1% (80.5% to 93.5%) for Veritor and 85.1% (74.3% to 92.6%) for Biosensor, among those who remained asymptomatic throughout. Specificities were >99%, and positive and negative predictive values were >90% and >95%, for both rapid antigen tests in all analyses.<h4>Conclusions</h4>The sensitivities of both rapid antigen tests in asymptomatic and presymptomatic close contacts tested on day 5 onwards after close contact with an index case were more than 60%, increasing to more than 85% after a viral load cut-off was applied as a proxy for infectiousness.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Prevention, Biodefense, Lung, Emerging Infectious Diseases, Vaccine Related, Clinical Research, 4.2 Evaluation of markers and technologies, 4 Detection, screening and diagnosis, Infection, 3 Good Health and Well Being |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Infection, Veterinary and Ecological Sciences |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 27 Jan 2022 15:28 |
| Last Modified: | 14 Apr 2024 08:56 |
| DOI: | 10.1136/bmj.n1676 |
| Open Access URL: | https://doi.org/10.1136/bmj.n1676 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3147720 |
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