Head-to-head comparison of the accuracy of saliva and nasal rapid antigen SARS-CoV-2 self-testing: cross-sectional study.

Antigen test COVID-19 Cross-sectional Study Diagnostic test accuracy Nasal test Rapid antigen detection test SARS-CoV-2 Saliva test

Journal

BMC medicine
ISSN: 1741-7015
Titre abrégé: BMC Med
Pays: England
ID NLM: 101190723

Informations de publication

Date de publication:
24 10 2022
Historique:
received: 14 03 2022
accepted: 11 10 2022
entrez: 25 10 2022
pubmed: 26 10 2022
medline: 27 10 2022
Statut: epublish

Résumé

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. 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. 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. 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.

Sections du résumé

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.

Identifiants

pubmed: 36280827
doi: 10.1186/s12916-022-02603-x
pii: 10.1186/s12916-022-02603-x
pmc: PMC9590385
doi:

Substances chimiques

Antigens, Viral 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

406

Informations de copyright

© 2022. The Author(s).

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Auteurs

Ewoud Schuit (E)

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands.
Cochrane Netherlands, University Medical Center Utrecht, Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands.

Roderick P Venekamp (RP)

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands.

Irene K Veldhuijzen (IK)

Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Antonie van Leeuwenhoeklaan 9, 3721 MA, Bilthoven, The Netherlands.

Wouter van den Bijllaardt (W)

Microvida Laboratory for Medical Microbiology, Amphia Hospital, Molengracht 21, 4818 CK, Breda, The Netherlands.
Department of Infection Control, Amphia Hospital, Molengracht 21, 4818 CK, Breda, The Netherlands.

Suzan D Pas (SD)

Microvida Laboratory for Medical Microbiology, Amphia Hospital, Molengracht 21, 4818 CK, Breda, The Netherlands.
Microvida Laboratory for Medical Microbiology, Bravis Hospital, Boerhaavelaan 25, 4708 AE, Roosendaal, The Netherlands.

Joep J J M Stohr (JJJM)

Department of Infection Control, Amphia Hospital, Molengracht 21, 4818 CK, Breda, The Netherlands.
Microvida Laboratory for Medical Microbiology, Elisabeth-TweeSteden Hospital, Hilvarenbeekseweg 60, 5022 GC, Tilburg, The Netherlands.

Esther B Lodder (EB)

Public Health Service West-Brabant, Doornboslaan 225-227, 4816 CZ, Breda, The Netherlands.

Marloes Hellwich (M)

Public Health Service Hart Voor Brabant, Reitseplein 3, 5037 AA, Tilburg, The Netherlands.

Richard Molenkamp (R)

Department of Viroscience, Erasmus MC, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.

Zsofia Igloi (Z)

Department of Viroscience, Erasmus MC, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.

Constantijn Wijers (C)

Public Health Service Rotterdam-Rijnmond, Schiedamsedijk 95, 3011 EN, Rotterdam, The Netherlands.

Irene H Vroom (IH)

Public Health Service Rotterdam-Rijnmond, Schiedamsedijk 95, 3011 EN, Rotterdam, The Netherlands.

Carla R S Nagel-Imming (CRS)

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands.

Wanda G H Han (WGH)

Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Antonie van Leeuwenhoeklaan 9, 3721 MA, Bilthoven, The Netherlands.

Jan A J W Kluytmans (JAJW)

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands.

Susan van den Hof (S)

Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Antonie van Leeuwenhoeklaan 9, 3721 MA, Bilthoven, The Netherlands.

Janneke H H M van de Wijgert (JHHM)

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands.

Karel G M Moons (KGM)

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands. k.g.m.moons@umcutrecht.nl.
Cochrane Netherlands, University Medical Center Utrecht, Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands. k.g.m.moons@umcutrecht.nl.

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