Schuit, Ewoud, Venekamp, Roderick P, Veldhuijzen, Irene K, van den Bijllaardt, Wouter, Pas, Suzan D, Stohr, Joep JJM, Lodder, Esther B, Hellwich, Marloes, Molenkamp, Richard, Igloi, Zsofia et al (show 8 more authors)
(2022)
Head-to-head comparison of the accuracy of saliva and nasal rapid antigen SARS-CoV-2 self-testing: cross-sectional study.
BMC medicine, 20 (1).
p. 406.
Abstract
<h4>Background</h4>The diagnostic accuracy of unsupervised self-testing with rapid antigen diagnostic tests (Ag-RDTs) is mostly unknown. We studied the diagnostic accuracy of a self-performed SARS-CoV-2 saliva and nasal Ag-RDT in the general population.<h4>Methods</h4>This large cross-sectional study consecutively included unselected individuals aged ≥ 16 years presenting for SARS-CoV-2 testing at three public health service test sites. Participants underwent molecular test sampling and received two self-tests (the Hangzhou AllTest Biotech saliva self-test and the SD Biosensor nasal self-test by Roche Diagnostics) to perform themselves at home. Diagnostic accuracy of both self-tests was assessed with molecular testing as reference.<h4>Results</h4>Out of 2819 participants, 6.5% had a positive molecular test. Overall sensitivities were 46.7% (39.3-54.2%) for the saliva Ag-RDT and 68.9% (61.6-75.6%) for the nasal Ag-RDT. With a viral load cut-off (≥ 5.2 log10 SARS-CoV-2 E-gene copies/mL) as a proxy of infectiousness, these sensitivities increased to 54.9% (46.4-63.3%) and 83.9% (76.9-89.5%), respectively. For the nasal Ag-RDT, sensitivities were 78.5% (71.1-84.8%) and 22.6% (9.6-41.1%) in those symptomatic and asymptomatic at the time of sampling, which increased to 90.4% (83.8-94.9%) and 38.9% (17.3-64.3%) after applying the viral load cut-off. In those with and without prior SARS-CoV-2 infection, sensitivities were 36.8% (16.3-61.6%) and 72.7% (65.1-79.4%). Specificities were > 99% and > 99%, positive predictive values > 70% and > 90%, and negative predictive values > 95% and > 95%, for the saliva and nasal Ag-RDT, respectively, in most analyses. Most participants considered the self-performing and result interpretation (very) easy for both self-tests.<h4>Conclusions</h4>The Hangzhou AllTest Biotech saliva self Ag-RDT is not reliable for SARS-CoV-2 detection, overall, and in all studied subgroups. The SD Biosensor nasal self Ag-RDT had high sensitivity in individuals with symptoms and in those without prior SARS-CoV-2 infection but low sensitivity in asymptomatic individuals and those with a prior SARS-CoV-2 infection which warrants further investigation.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Saliva, Humans, Antigens, Viral, Sensitivity and Specificity, Cross-Sectional Studies, COVID-19, SARS-CoV-2, COVID-19 Testing |
| 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: | 26 Mar 2024 10:49 |
| Last Modified: | 26 Mar 2024 15:30 |
| DOI: | 10.1186/s12916-022-02603-x |
| Open Access URL: | https://doi.org/10.1186/s12916-022-02603-x |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3179957 |
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