| Title: |
Head-to-head comparison of the accuracy of saliva and nasal rapid antigen SARS-CoV-2 self-testing:cross-sectional study |
| Authors: |
Schuit, Ewoud; Venekamp, Roderick P.; Veldhuijzen,Irene K.; van den Bijllaardt,Wouter; Pas,Suzan D.; Stohr,Joep J.J.M.; Lodder,Esther B.; Hellwich,Marloes; Molenkamp,Richard; Igloi,Zsofia; Wijers,Constantijn; Vroom,Irene H.; Nagel-Imming,Carla R.S.; Han,Wanda G.H.; Kluytmans, Jan A.J.W.; van den Hof,Susan; van de Wijgert, Janneke H.H.M.; Moons, Karel G.M.; Epi Methoden Team 4; JC onderzoeksprogramma Methodology; HAG Onderzoek; Child Health; Infection & Immunity; JC onderzoeksprogramma Infectious Diseases; Medische Microbiologie; Epi Infectieziekten Team 1b; Epi Methoden; Cancer |
| Publication Year: |
2022 |
| Subject Terms: |
Antigen test; COVID-19; Cross-sectional Study; Diagnostic test accuracy; Nasal test; Rapid antigen detection test; Saliva test; SARS-CoV-2; General Medicine; Journal Article |
| Description: |
Background: 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. Methods: 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. Results: 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. Conclusions: 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 ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
text/plain |
| Language: |
English |
| ISSN: |
1741-7015 |
| Relation: |
https://dspace.library.uu.nl/handle/1874/447385 |
| Availability: |
https://dspace.library.uu.nl/handle/1874/447385 |
| Rights: |
info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.EBEB32C5 |
| Database: |
BASE |