TY - JOUR
T1 - Head-to-head comparison of the accuracy of saliva and nasal rapid antigen SARS-CoV-2 self-testing
T2 - cross-sectional study
AU - Schuit, Ewoud
AU - Venekamp, Roderick P.
AU - Veldhuijzen, Irene K.
AU - van den Bijllaardt, Wouter
AU - Pas, Suzan D.
AU - Stohr, Joep J.J.M.
AU - Lodder, Esther B.
AU - Hellwich, Marloes
AU - Molenkamp, Richard
AU - Igloi, Zsofia
AU - Wijers, Constantijn
AU - Vroom, Irene H.
AU - Nagel-Imming, Carla R.S.
AU - Han, Wanda G.H.
AU - Kluytmans, Jan A.J.W.
AU - van den Hof, Susan
AU - van de Wijgert, Janneke H.H.M.
AU - Moons, Karel G.M.
N1 - Funding Information:
This study was funded by the Dutch Ministry of Health, Welfare, and Sport. The funder had no role in the study design; collection, analysis, and interpretation of data; writing of the report and decision to submit the paper for publication.
Publisher Copyright: © 2022, The Author(s).
PY - 2022/10/24
Y1 - 2022/10/24
N2 - 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 infection but low sensitivity in asymptomatic individuals and those with a prior SARS-CoV-2 infection which warrants further investigation.
AB - 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 infection but low sensitivity in asymptomatic individuals and those with a prior SARS-CoV-2 infection which warrants further investigation.
UR - http://www.scopus.com/inward/record.url?scp=85140483795&partnerID=8YFLogxK
U2 - 10.1186/s12916-022-02603-x
DO - 10.1186/s12916-022-02603-x
M3 - Article
C2 - 36280827
AN - SCOPUS:85140483795
SN - 1741-7015
VL - 20
JO - BMC Medicine
JF - BMC Medicine
IS - 1
M1 - 406
ER -
