ORCID

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.

Publication Date

2024-06-10

Publication Title

Eur J Clin Microbiol Infect Dis

Volume

43

Issue

8

Acceptance Date

2024-05-28

Deposit Date

2024-11-08

Funding

The project was funded by UKHSA\u2019s predecessor organisation NHS Test and Trace (part of the Department of Health and Social Care). TF, MEF, SAT, EB, OK, SSC, AD, LD and SHo are employees of the UK Health Security Agency, which succeeded the NHS Test and Trace service in the United Kingdom. SHi is an employee of NHS England. MS is a consultant for Synnovis and has previously received consulting fees from CSL Seqirus, support for attending meetings and/or travel from AMP Europe and Velsera. SHo and TP are supported by the National Institute for Health Research (NIHR) Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance (NIHR200915), a partnership between the UK Health Security Agency (UKHSA) and the University of Oxford. DC, ET and PK declare no conflicts of interest.

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, COVID-19, Self-testing, Testing programme, Self-swabbing, PCR

First Page

1621

Last Page

1630

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