TY - JOUR
T1 - Self-swabbing versus assisted swabbing for viral detection by qRT-PCR
T2 - the experience from SARS-CoV-2 based on a meta-analysis of six prospectively designed evaluations conducted in a UK setting
AU - Fowler, Tom
AU - Chapman, David
AU - Futschik, Matthias E
AU - Tunkel, Sarah A
AU - Blandford, Edward
AU - Turek, Elena
AU - Kolade, Olumide
AU - da Cunha, Sergio Souza
AU - Dodgson, Andrew
AU - Klapper, Paul
AU - Sudhanva, Malur
AU - Davies, Lindsey
AU - Hill, Sue
AU - Hopkins, Susan
AU - Peto, Tim
N1 - © 2024. Crown.
PY - 2024/6/10
Y1 - 2024/6/10
N2 - 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.
AB - 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.
KW - Adult
KW - Female
KW - Humans
KW - Male
KW - COVID-19/diagnosis
KW - COVID-19 Nucleic Acid Testing/methods
KW - COVID-19 Testing/methods
KW - Nose/virology
KW - Pharynx/virology
KW - Prospective Studies
KW - SARS-CoV-2/genetics
KW - Sensitivity and Specificity
KW - Specimen Handling/methods
KW - United Kingdom
KW - COVID-19
KW - Self-testing
KW - Testing programme
KW - Self-swabbing
KW - PCR
UR - http://www.scopus.com/inward/record.url?scp=85195512797&partnerID=8YFLogxK
U2 - 10.1007/s10096-024-04866-z
DO - 10.1007/s10096-024-04866-z
M3 - Article
C2 - 38856828
SN - 1435-4373
VL - 43
SP - 1621
EP - 1630
JO - Eur J Clin Microbiol Infect Dis
JF - Eur J Clin Microbiol Infect Dis
IS - 8
ER -