Comparing SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing/self-sampling with molecular and professional-use tests

• Verfasst von: Katzenschlager, Stephan [VerfasserIn]
• Verfasst von: Brümmer, Lukas E. [VerfasserIn]
• Verfasst von: Schmitz, Stephani [VerfasserIn]
• Verfasst von: Tolle, Hannah [VerfasserIn]
• Verfasst von: Manten, Katharina [VerfasserIn]
• Verfasst von: Gaeddert, Mary [VerfasserIn]
• Verfasst von: Erdmann, Christian [VerfasserIn]
• Verfasst von: Lindner, Andreas [VerfasserIn]
• Verfasst von: Tobian, Frank [VerfasserIn]
• Verfasst von: Grilli, Maurizio [VerfasserIn]
• Verfasst von: Pollock, Nira R. [VerfasserIn]
• Verfasst von: Macé, Aurélien [VerfasserIn]
• Verfasst von: Erkosar, Berra [VerfasserIn]
• Verfasst von: Carmona, Sergio [VerfasserIn]
• Verfasst von: Ongarello, Stefano [VerfasserIn]
• Verfasst von: Johnson, Cheryl C. [VerfasserIn]
• Verfasst von: Sacks, Jilian A. [VerfasserIn]
• Verfasst von: Denkinger, Claudia M. [VerfasserIn]
• Verfasst von: Yerlikaya, Seda [VerfasserIn]
• Titel: Comparing SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing/self-sampling with molecular and professional-use tests
• Titelzusatz: a systematic review and meta-analysis
• Verf.angabe: Stephan Katzenschlager, Lukas E. Brümmer, Stephani Schmitz, Hannah Tolle, Katharina Manten, Mary Gaeddert, Christian Erdmann, Andreas Lindner, Frank Tobian, Maurizio Grilli, Nira R. Pollock, Aurélien Macé, Berra Erkosar, Sergio Carmona, Stefano Ongarello, Cheryl C. Johnson, Jilian A. Sacks, Claudia M. Denkinger & Seda Yerlikaya
• E-Jahr: 2023
• Jahr: 11 December 2023
• Umfang: 15 S.
• Illustrationen: Illustrationen
• Fussnoten: Gesehen am 09.04.2024
• Titel Quelle: Enthalten in: Scientific reports
• Ort Quelle: [London] : Springer Nature, 2011
• Jahr Quelle: 2023
• Band/Heft Quelle: 13(2023) vom: Dez., Artikel-ID 21913, Seite 1-15
• ISSN Quelle: 2045-2322
• DOI: doi:10.1038/s41598-023-48892-x
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: Epidemiology
• Sach-SW: Infectious diseases
• K10plus-PPN: 1885400659

Abstract

Self-testing is an effective tool to bridge the testing gap for several infectious diseases; however, its performance in detecting SARS-CoV-2 using antigen-detection rapid diagnostic tests (Ag-RDTs) has not been systematically reviewed. This study aimed to inform WHO guidelines by evaluating the accuracy of COVID-19 self-testing and self-sampling coupled with professional Ag-RDT conduct and interpretation. Articles on this topic were searched until November 7th, 2022. Concordance between self-testing/self-sampling and fully professional-use Ag-RDTs was assessed using Cohen’s kappa. Bivariate meta-analysis yielded pooled performance estimates. Quality and certainty of evidence were evaluated using QUADAS-2 and GRADE tools. Among 43 studies included, twelve reported on self-testing, and 31 assessed self-sampling only. Around 49.6% showed low risk of bias. Overall concordance with professional-use Ag-RDTs was high (kappa 0.91 [95% confidence interval (CI) 0.88-0.94]). Comparing self-testing/self-sampling to molecular testing, the pooled sensitivity and specificity were 70.5% (95% CI 64.3-76.0) and 99.4% (95% CI 99.1-99.6), respectively. Higher sensitivity (i.e., 93.6% [95% CI 90.4-96.8] for Ct < 25) was estimated in subgroups with higher viral loads using Ct values as a proxy. Despite high heterogeneity among studies, COVID-19 self-testing/self-sampling exhibits high concordance with professional-use Ag-RDTs. This suggests that self-testing/self-sampling can be offered as part of COVID-19 testing strategies.