Self-swabbing versus assisted swabbing for viral detection by qRT-PCR: the experience from SARS-CoV-2 based on a meta-analysis of six prospectively designed evaluations conducted in a UK setting

Authors

Tom Fowler, UK Health Security Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU, UK. tom.fowler2@ukhsa.gov.uk.
David Chapman, School of Art, Design and Architecture
Matthias E Futschik, School of Biomedical Sciences
Sarah A Tunkel, UK Health Security Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU, UK.
Edward Blandford, UK Health Security Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU, UK.
Elena Turek, Deloitte, London, United Kingdom, Deloitte MCS Ltd, London, United Kingdom.
Olumide Kolade, UK Health Security Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU, UK.
Sergio Souza da Cunha, UK Health Security Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU, UK.
Andrew Dodgson, UK Health Security Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU, UK.
Paul Klapper, UK Health Security Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU, UK.
Malur Sudhanva, UK Health Security Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU, UK.
Lindsey Davies, UK Health Security Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU, UK.
Sue Hill, UK Health Security Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU, UK.
Susan Hopkins, UK Health Security Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU, UK.
Tim Peto, University of Oxford

ORCID

• Matthias E Futschik: 0000-0002-6245-8071

Abstract

PURPOSE: In April 2020, the UK Government implemented NHS Test and Trace to provide SARS-CoV-2 quantitative reverse transcription polymerase chain reaction (qRT-PCR) testing for the public, with nose-and-throat swabbing for samples performed by trained staff. Self-swabbing (SS) would allow rapid scale-up of testing capacity and access. Six studies were undertaken to determine whether SS was as effective for detecting SARS-CoV-2 as swabbing performed by trained staff.

METHODS: Six prospective studies were conducted between April-October 2020, using six swab/media combinations. Differences between assisted swabbing (AS) and SS were evaluated for concordance, positivity, sensitivity, cycle threshold (Ct) values and void rates. Statistical analysis was performed using 95% confidence intervals (CIs), paired t-tests and model-based methods.

RESULTS: Overall, 3,253 individuals were recruited (median age 37 years, 49% female), with 2,933 having valid paired qRT-PCR results. Pooled concordance rate was 98% (95% CI: 96%, 99%). Positivity rate differences for SS (8.1%) and AS (8.4%) and differences in pooled sensitivities between SS (86%; 95% CI: 78%, 92%) and AS (91%; 95% CI: 78%, 96%) were nonsignificant. Both types of swabbing led to pooled void rates below 2% and strongly correlated Ct values. Age, sex and previous swabbing experience did not have a significant impact on concordance or sensitivity.

CONCLUSION: The UK adopted a policy to promote self-testing for SARS-CoV-2 based on data demonstrating equivalence of SS versus AS. Positive outcomes with SS are likely generalisable to testing for other respiratory pathogens, and we consider self-sampling and self-testing essential for future pandemic preparedness.

DOI

10.1007/s10096-024-04866-z

Publication Date

2024-06-10

Publication Title

Eur J Clin Microbiol Infect Dis

Volume

43

Issue

8

Keywords

Adult, Female, Humans, Male, COVID-19/diagnosis, COVID-19 Nucleic Acid Testing/methods, COVID-19 Testing/methods, Nose/virology, Pharynx/virology, Prospective Studies, SARS-CoV-2/genetics, Sensitivity and Specificity, Specimen Handling/methods, United Kingdom

First Page

1621

Last Page

1630

Recommended Citation

Fowler, T., Chapman, D., Futschik, M., Tunkel, S., Blandford, E., Turek, E., Kolade, O., da Cunha, S., Dodgson, A., Klapper, P., Sudhanva, M., Davies, L., Hill, S., Hopkins, S., & Peto, T. (2024) 'Self-swabbing versus assisted swabbing for viral detection by qRT-PCR: the experience from SARS-CoV-2 based on a meta-analysis of six prospectively designed evaluations conducted in a UK setting', Eur J Clin Microbiol Infect Dis, 43(8), pp. 1621-1630. Available at: 10.1007/s10096-024-04866-z" >https://doi.org/10.1007/s10096-024-04866-z