10.6084/M9.FIGSHARE.C.6264952
Ewoud Schuit
Ewoud
Schuit
0000-0002-9548-3214
Utrecht University
University Medical Center Utrecht
Roderick P. Venekamp
Roderick P.
Venekamp
0000-0002-1446-9614
Utrecht University
University Medical Center Utrecht
Irene K. Veldhuijzen
Irene K.
Veldhuijzen
0000-0002-3132-4070
National Institute for Public Health and the Environment
Wouter van den Bijllaardt
Wouter
van den Bijllaardt
0000-0003-0676-2594
Amphia Ziekenhuis
Suzan D. Pas
Suzan D.
Pas
0000-0003-1943-1217
Amphia Ziekenhuis
Joep J. J. M. Stohr
Joep J. J. M.
Stohr
0000-0002-4021-9635
Amphia Ziekenhuis
Elisabeth-TweeSteden Ziekenhuis
Esther B. Lodder
Esther B.
Lodder
Marloes Hellwich
Marloes
Hellwich
0000-0001-7539-4233
Richard Molenkamp
Richard
Molenkamp
0000-0002-9004-3850
Erasmus MC
Zsofia Igloi
Zsofia
Igloi
0000-0001-7537-6334
Erasmus MC
Constantijn Wijers
Constantijn
Wijers
Irene H. Vroom
Irene H.
Vroom
Carla R. S. Nagel-Imming
Carla R. S.
Nagel-Imming
Utrecht University
University Medical Center Utrecht
Wanda G. H. Han
Wanda G. H.
Han
0000-0003-0503-9783
National Institute for Public Health and the Environment
Jan A. J. W. Kluytmans
Jan A. J. W.
Kluytmans
0000-0003-2665-6844
Utrecht University
Susan van den Hof
Susan
van den Hof
0000-0002-2968-9652
National Institute for Public Health and the Environment
Janneke H. H. M. van de Wijgert
Janneke H. H. M.
van de Wijgert
0000-0003-2728-4560
Utrecht University
University Medical Center Utrecht
Karel G. M. Moons
Karel G. M.
Moons
0000-0003-2118-004X
Utrecht University
University Medical Center Utrecht
Head-to-head comparison of the accuracy of saliva and nasal rapid antigen SARS-CoV-2 self-testing: cross-sectional study
Abstract 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 $$\ge$$ ≥ 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 infection but low sensitivity in asymptomatic individuals and those with a prior SARS-CoV-2 infection which warrants further investigation.
Medicine
Microbiology
Genetics
Evolutionary Biology
Sociology
19999 Mathematical Sciences not elsewhere classified
111714 Mental Health
110309 Infectious Diseases
60506 Virology
Computational Biology
figshare
2022
2022-10-25
2022-10-25
Collection
10.1186/s12916-022-02603-x
CC BY 4.0