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Katzenschlager, Stephan; Brümmer, Lukas E.; Schmitz, Stephani; Tolle, Hannah; Manten, Katharina; Gaeddert, Mary; Erdmann, Christian; Lindner, Andreas; Tobian, Frank; Grilli, Maurizio; Pollock, Nira R.; Macé, Aurélien; Erkosar, Berra; Carmona, Sergio; Ongarello, Stefano; Johnson, Cheryl C.; Sacks, Jilian A.; Denkinger, Claudia M.; Yerlikaya, Seda

Comparing SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing/self-sampling with molecular and professional-use tests: a systematic review and meta-analysis

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  • Medientyp: E-Artikel
  • Titel: Comparing SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing/self-sampling with molecular and professional-use tests: a systematic review and meta-analysis
  • Beteiligte: Katzenschlager, Stephan; Brümmer, Lukas E.; Schmitz, Stephani; Tolle, Hannah; Manten, Katharina; Gaeddert, Mary; Erdmann, Christian; Lindner, Andreas; Tobian, Frank; Grilli, Maurizio; Pollock, Nira R.; Macé, Aurélien; Erkosar, Berra; Carmona, Sergio; Ongarello, Stefano; Johnson, Cheryl C.; Sacks, Jilian A.; Denkinger, Claudia M.; Yerlikaya, Seda
  • Erschienen: Springer Science and Business Media LLC, 2023
  • Erschienen in: Scientific Reports, 13 (2023) 1
  • Sprache: Englisch
  • DOI: 10.1038/s41598-023-48892-x
  • ISSN: 2045-2322
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: AbstractSelf-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.Trial registration: PROSPERO: CRD42021250706.
  • Zugangsstatus: Freier Zugang