Article
The clinical utility and epidemiological impact of self-testing for SARS-CoV-2 using antigen detecting diagnostics: a systematic review and meta-analysis
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Authors
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Lukas E. Brümmer
- Department of Infectious Disease and Tropical Medicine, Center for Infectious Diseases, Heidelberg University Hospital, Heidelberg, Germany; German Center for Infection Research (DZIF), partner site Heidelberg University Hospital, Heidelberg, Germany
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Ana-Mihaela Zorger
- Institute for Public Health, University of Cologne, Köln, Germany
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Karina Worbes
- Institute for Public Health, University of Cologne, Köln, Germany
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Sean McGrath
- Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, United States
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Christian Erdmann
- FH Muenster University of Applied Sciences, Münster, Germany
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Hannah Tolle
- German Center for Infection Research (DZIF), partner site Heidelberg University Hospital, Heidelberg, Germany
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Stephan Katzenschlager
- Department of Anesthesiology, Heidelberg University Hospital, Heidelberg, Germany
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Seda Yerlikaya
- Department of Infectious Disease and Tropical Medicine, Center for Infectious Diseases, Heidelberg University Hospital, Heidelberg, Germany
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Maurizio Grilli
- Library, University Medical Center Mannheim, Mannheim, Germany
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Nira R. Pollock
- Department of Laboratory Medicine, Boston Children’s Hospital, Boston, United States
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Berra Erkosar
- FIND, Geneva, Switzerland
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Aurelien Mace
- FIND, Geneva, Switzerland
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Stefano Ongarello
- International Federation of Red Cross and Red Crescent Societies, Geneva, United States
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Cheryl C. Johnson
- Global HIV, Hepatitis and STIs Programmes, World Health Organization, Geneva, Switzerland
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Jane Cunningham
- Emerging Diseases and Zoonoses, Epidemic and Pandemic Preparedness and Prevention World Health Organization, Geneva, Switzerland
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Jilian A. Sacks
- Global Health Policy Department, Roche, Geneva, Switzerland
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Nicole Skoetz
- Institute for Public Health, University of Cologne, Köln, Germany
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Rose A. Lee
- Department of Pediatrics, Harvard Medical School, Boston, United States
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Claudia M. Denkinger
- Department of Infectious Disease and Tropical Medicine, Center for Infectious Diseases, Heidelberg University Hospital, Heidelberg, Germany; German Center for Infection Research (DZIF), partner site Heidelberg University Hospital, Heidelberg, Germany
| Published: | September 6, 2024 |
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Outline
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Background: Even though self-testing for COVID-19 (C19ST) based on antigen-detecting diagnostics has been implemented widely throughout the COVID-19 pandemic, its actual benefit on population health is uncertain. To guide future use of C19ST as well as its potential role in pandemic preparedness, we performed and updated a systematic review and meta-analysis of studies evaluating the epidemiological impact and clinical utility of implementing C19ST in an asymptomatic or symptomatic population during the COVID-19 pandemic. Initial results of this review informed World Health Organization (WHO) 2022 guidelines [1].
Methods: The review was registered on PROSPERO (CRD42022299977). We systematically searched MEDLINE (via PubMed) and Web of Science core collection, performed secondary reference screening, and contacted experts for further relevant publications. Any peer-reviewed or pre-print study published between December 1, 2020 and March 13, 2023 analyzing the epidemiological impact and clinical utility of C19ST was included. Studies’ outcomes were evaluated at both community- and individual-level including C19ST, including case detection, proportion of false positive test results, missed cases, uptake, and benefits within people’s daily routines. Study quality was assessed using the Joanna Briggs Critical Appraisal Tool.
Results: Out of 12,018 studies identified, 29 met inclusion criteria. Studies were predominantly from Europe and the US, encompassing 1,227,970 participants (67.4% asymptomatic, 0.3% symptomatic, 32.3% with unclear symptom status). Compared to no other dedicated testing available in a given setting, C19ST detected an incremental 11 (95% CI: 5-26) individuals with a potential SARS-CoV-2 infection per 1000 people tested. However, 15% (95% CI: 5-40%) of positive C19ST results were false-positives. Despite widespread implementation, C19ST could miss 14 (95% CI: 5-36) COVID-19 cases per 1000 people tested, compared to testing with reverse transcriptase polymerase chain reaction (RT-PCR). The aggregate uptake of C19ST was high (44% [95% CI 31-56%]) and further increased when implemented in schools or workplaces (up to 82% [76% to 87%]). C19ST reduced the time to diagnosis and workplace absenteeism, enabled individuals to be exempted from self-isolation, and led to an increased feeling of safety in school and at work. Most of the studies included were of low to moderate certainty, and heterogeneity was high (I2 > 98%).
Conclusions: C19ST may detect additional individuals with SARS-CoV-2, who are likely to be infectious and could be missed by alternative testing options. However, some of the C19ST results might be false-positive and even widespread C19ST of symptomatic and asymptomatic individuals could lead to missing cases. On an individual level, C19ST may reduce time to diagnosis, time in self-isolation, and workplace absenteeism. Low study quality and high heterogeneity of data limits the interpretation of our results. C19ST is recommended as a testing approach, but its use needs to be strategic and guided by local context and latest epidemiological information.
The authors declare that they have no competing interests.
The authors declare that an ethics committee vote is not required.
References
- 1.
- World Health Organization. Use of SARS-CoV-2 antigen detection rapid diagnostic tests for COVID-19 self-testing - Interim Guidance. WHO Reference Number: WHO/2019-nCoV/Ag-RDTs/Self_testing/2022.1. Geneva (Switzerland): WHO; 9 March 2022 [accessed 29 April 2024]. Available from: https://www.who.int/publications/i/item/WHO-2019-nCoV-Ag-RDTs-Self_testing-2022.1
