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.

Autor: Katzenschlager S; Department of Anesthesiology, Medical Faculty Heidelberg, Heidelberg University, Heidelberg, Germany., Brümmer LE; Division of Infectious Disease and Tropical Medicine, Center for Infectious Diseases, Heidelberg University Hospital, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany.; German Center for Infection Research (DZIF), Partner Site Heidelberg University Hospital, Heidelberg, Germany., Schmitz S; Division of Infectious Disease and Tropical Medicine, Center for Infectious Diseases, Heidelberg University Hospital, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany.; Department of Developmental Biology, Erasmus Medical Center, Rotterdam, The Netherlands., Tolle H; Division of Infectious Disease and Tropical Medicine, Center for Infectious Diseases, Heidelberg University Hospital, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany., Manten K; Department of Anesthesiology, Medical Faculty Heidelberg, Heidelberg University, Heidelberg, Germany.; Division of Infectious Disease and Tropical Medicine, Center for Infectious Diseases, Heidelberg University Hospital, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany., Gaeddert M; Division of Infectious Disease and Tropical Medicine, Center for Infectious Diseases, Heidelberg University Hospital, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany., Erdmann C; FH Muenster University of Applied Sciences, Muenster, Germany., Lindner A; Charité Center for Global Health, Institute of International Health, Charité - Universitätsmedizin Berlin, Berlin, Germany., Tobian F; Division of Infectious Disease and Tropical Medicine, Center for Infectious Diseases, Heidelberg University Hospital, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany., Grilli M; University Medical Center Mannheim, Mannheim, Germany., Pollock NR; Department of Laboratory Medicine, Boston Children's Hospital, Boston, MA, USA., Macé A; FIND, Geneva, Switzerland., Erkosar B; FIND, Geneva, Switzerland., Carmona S; FIND, Geneva, Switzerland., Ongarello S; FIND, Geneva, Switzerland., Johnson CC; Global HIV, Hepatitis and STIs Programmes, World Health Organization, Geneva, Switzerland., Sacks JA; Department of Epidemic and Pandemic Preparedness and Prevention, World Health Organization, Geneva, Switzerland., Denkinger CM; Division of Infectious Disease and Tropical Medicine, Center for Infectious Diseases, Heidelberg University Hospital, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany.; German Center for Infection Research (DZIF), Partner Site Heidelberg University Hospital, Heidelberg, Germany., Yerlikaya S; Division of Infectious Disease and Tropical Medicine, Center for Infectious Diseases, Heidelberg University Hospital, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany. seda.yerlikaya@uni-heidelberg.de.
Jazyk: angličtina
Zdroj: Scientific reports [Sci Rep] 2023 Dec 11; Vol. 13 (1), pp. 21913. Date of Electronic Publication: 2023 Dec 11.
DOI: 10.1038/s41598-023-48892-x
Abstrakt: 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.Trial registration: PROSPERO: CRD42021250706.
(© 2023. The Author(s).)
Databáze: MEDLINE
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