The clinical utility and epidemiological impact of self-testing for SARS-CoV-2 using antigen detecting diagnostics: a systematic review and meta-analysis

Brümmer, Lukas E.; Erdmann, Christian; Tolle, Hannah; McGrath, Seán; Olaru, Ioana D.; Katzenschlager, Stephan; Yerlikaya, Seda; Grilli, Maurizio; Pollock, Nira R.; Erkoşar, Berra; Macé, Aurélien; Johnson, Cheryl; Sacks, Jilian A.; Denkinger, Claudia M.

doi:10.1101/2022.07.03.22277183

Cited by 5 publications

(6 citation statements)

References 36 publications

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“…Self-testing has become more acceptable and feasible, and may reduce the burden on existing diagnostics of SARS-CoV-2. Furthermore self-testing combined with self-quarantine may help reduce spread of SARS-CoV-2 (Brümmer, et al, 2022). The guidelines of the WHO state a sensitivity of ≥ 80% and a specificity of ≥ 97% for antigen rapid tests using nasal and/or naso-pharyngeal samples, but these criteria are for individuals with symptoms of SARS-CoV-2 (World Health Organization, 9 March 2022).…”

Section: Discussionmentioning

confidence: 99%

Comparison of COVID-19 Antigen Rapid Test (Oral Fluid) and Real-Time RT-PCR in the laboratory diagnosis of SARS-CoV-2 infection

Mense

Ouburg

2022

Preprint

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Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) was first diagnosed in December 2019. Since then this virus has caused an ongoing wide pandemic. Accurate diagnostic tests for SARS-CoV-2 are used to prevent the virus from spreading. However, these tests could not keep up with the demand and were not available in all places. Self-testing devices are easy-to-use-tests and reduce the demand in the diagnostic laboratories. The Antigen Rapid Test evaluated in this study uses oral fluid which is a non-invasive technique compared to nasopharyngeal swabs. In this study the COVID-19 Antigen Rapid Test (Oral fluid) was evaluated with 150 SARS-CoV-2 positive saliva specimens and 350 SARS-CoV-2 negative saliva specimens. The Antigen Rapid Test was performed according to the instruction manual. SARS-CoV-2 Real-time RT-PCR was used as Golden Standard. Although the criteria of the WHO are specific to nasal / nasopharyngeal samples (and not saliva), the specificity of the Antigen Rapid Test meets the criteria of the World Health Organization (WHO; specificity ≥ 97%). The test meets the WHO sensitivity criteria in samples with higher viral loads (Ct<30), showing the better performance of the test in highly positive samples. For positive SARS-CoV-2 specimens with a Ct value lower than 30 a sensitivity of 83.8% (95% CI: 80.1%-86.8%) and an accuracy of 95.9% (95% CI: 93.7%-97.4%) was observed. This shows that this assay with saliva samples is able to meet the high standards set by the WHO. The performance of the test is comparable to other antigen rapid tests reported in meta-analyses. Furthermore, the test allows self-testing which is non-invasive, affordable and straightforward. This antigen rapid test may provide an affordable, quick, and easy to perform method to differentiate between individuals with high and low viral loads.

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Section: Discussionmentioning

confidence: 99%

Comparison of COVID-19 Antigen Rapid Test (Oral Fluid) and Real-Time RT-PCR in the laboratory diagnosis of SARS-CoV-2 infection

Mense

Ouburg

2022

Preprint

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“…In particular, the pandemic put unprecedented strain on global health systems, leading to an urgent need for rapid and accessible testing modalities particularly in low- and middle-income countries (LMICs). This resulted in the widespread adoption of antigen-based rapid diagnostic tests (Ag-RDTs), which can affordably provide same-day results, early diagnosis, and prompt referrals to onward services and care, including quarantine or treatment, to protect the most vulnerable [ 3 ]. C19ST was thought to reduce absenteeism at work, made people feel safer and increased uptake and identification of new cases [ 3 ].…”

Section: Introductionmentioning

confidence: 99%

“…This resulted in the widespread adoption of antigen-based rapid diagnostic tests (Ag-RDTs), which can affordably provide same-day results, early diagnosis, and prompt referrals to onward services and care, including quarantine or treatment, to protect the most vulnerable [ 3 ]. C19ST was thought to reduce absenteeism at work, made people feel safer and increased uptake and identification of new cases [ 3 ].…”

Section: Introductionmentioning

confidence: 99%

COVID-19 self-testing: Countries accelerating policies ahead of WHO guidelines during pandemics, a global consultation

Sakala,

Johnson,

Chirombo

et al. 2024

PLOS Glob Public Health

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The widespread use of antigen-detection rapid diagnostic tests (Ag-RDTs) has revolutionized SARS-CoV-2 (COVID-19) testing, particularly through the option of self-testing. The full extent of Ag-RDT utilization for self-testing, however, remains largely unexplored. To inform the development of WHO guidance on COVID-19 self-testing, we conducted a global consultation to gather the views and experiences of policy makers, researchers, and implementers worldwide. The consultation was conducted by disseminating a WHO questionnaire through professional networks via email and social media, encouraging onward sharing. We used a cross-sectional design with both closed and open-ended questions related to policy and program information concerning the regulation, availability, target population, indications, implementation, benefits, and challenges of COVID-19 self-testing (C19ST). We defined self-testing as tests performed and interpreted by an untrained individual, often at home. Descriptive summaries, cross-tabulations, and proportions were used to calculate outcomes at the global level and by WHO region and World Bank income classifications. All information was collated and reported according to WHO guideline development standards and practice for global consultations. Between 01 and 11 February 2022, 844 individuals from 139 countries responded to the survey, with 45% reporting affiliation with governments and 47% operating at the national level. 504 respondents from 101 countries reported policies supporting C19ST for a range of use cases, including symptomatic and asymptomatic populations. More respondents from low-and-middle-income countries (LMICs) than high-income countries (HICs) reported a lack of an C19ST policy (61 vs 11 countries) and low population-level reach of C19ST. Respondents with C19ST experience perceived that the tests were mostly acceptable to target populations, provided significant benefits, and highlighted several key challenges to be addressed for increased success. Reported costs varied widely, ranging from specific programmes enabling free access to certain users and others with high costs via the private sector. Based on this consultation, systems for the regulatory review, policy development and implementation of C19ST appeared to be much more common in HIC when compared to LIC in early 2022, though most respondents indicated self-testing was available to some extent (101 out of 139 countries) in their country. Addressing such global inequities is critical for ensuring access to innovative and impactful interventions in the context of a public health emergency of international concern. The challenges and opportunities highlighted by key stakeholders could be valuable to consider as future testing strategies are being set for outbreak-prone diseases.

show abstract

“…In particular, the pandemic put unprecedented strain on global health systems, leading to an urgent need for rapid and accessible testing modalities particularly in low-and middle-income countries (LMICs). This resulted in the widespread adoption of antigen-based rapid diagnostic tests (Ag-RDTs), which can affordably provide same-day results, early diagnosis, and prompt referrals to onward services and care, including quarantine or treatment, to protect the most vulnerable (3).…”

Section: Introductionmentioning

confidence: 99%

“…C19ST was thought to reduce absenteeism at work, made people feel safer and increased uptake and identification of new cases (3).…”

Section: Introductionmentioning

confidence: 99%

COVID-19 self-testing: Countries accelerating policies ahead of WHO guidelines during pandemics: A Global Survey

Sakala,

Johnson,

Chirombo

et al. 2023

Preprint

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Introduction The widespread use of antigen-detection rapid diagnostic tests (Ag-RDTs) has revolutionized SARS-CoV-2 (COVID-19) testing, particularly through the option of self-testing. The full extent of Ag-RDT utilization for self-testing, however, remains largely unexplored. To inform the development of WHO guidance on COVID-19 self-testing, we conducted a cross-sectional survey to gather the views and experiences of policy makers, researchers, and implementers worldwide. Methods The survey was shared through professional networks via email and social media, encouraging onward sharing. We used closed and open-ended questions related to policy and program information concerning the regulation, availability, target population, indications, implementation, benefits, and challenges of COVID-19 self-testing (C19ST). We defined self-testing as tests performed and interpreted by an untrained individual, often at home. Descriptive summaries, cross-tabulations, and proportions were used to calculate outcomes at the global level and by WHO region and World Bank income classifications. Results Between 01 and 11 February 2022, 844 individuals from 139 countries responded to the survey, with 45% reporting affiliation with governments and 47% operating at the national level. 504 respondents from 101 countries reported policies supporting C19ST for a range of use cases, including symptomatic and asymptomatic populations. More respondents from low-and-middle-income countries (LMICs) than high-income countries (HICs) reported a lack of an C19ST policy (61 vs 11 countries) and low population-level reach of C19ST. Respondents with C19ST experience perceived that the tests were mostly acceptable to target populations, provided significant benefits, and highlighted several key challenges to be addressed for increased success. Reported costs varied widely, ranging from specific programmes enabling free access to certain users and others with high costs via the private sector. Conclusion Based on the survey responses, systems for the regulatory review, policy development and implementation of C19STappeared to be much more common in HIC when compared to LIC in early 2022, though most respondents indicated self-testing was available to some extent (101 out of 139 countries) in their country. Addressing such global inequities is critical for ensuring access to innovative and impactful interventions in the context of a public health emergency of international concern. The challenges and opportunities highlighted by survey respondents could be valuable to consider as future testing strategies are being set for outbreak-prone diseases.

show abstract

The clinical utility and epidemiological impact of self-testing for SARS-CoV-2 using antigen detecting diagnostics: a systematic review and meta-analysis

Cited by 5 publications

References 36 publications

Comparison of COVID-19 Antigen Rapid Test (Oral Fluid) and Real-Time RT-PCR in the laboratory diagnosis of SARS-CoV-2 infection

Comparison of COVID-19 Antigen Rapid Test (Oral Fluid) and Real-Time RT-PCR in the laboratory diagnosis of SARS-CoV-2 infection

COVID-19 self-testing: Countries accelerating policies ahead of WHO guidelines during pandemics, a global consultation

COVID-19 self-testing: Countries accelerating policies ahead of WHO guidelines during pandemics: A Global Survey

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