UK Health Security Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU, UK.
William Harvey Research Institute and the Barts Cancer Institute, Queen Mary University of London, London, UK.
Eur J Clin Microbiol Infect Dis. 2024 Aug;43(8):1621-1630. doi: 10.1007/s10096-024-04866-z. Epub 2024 Jun 10.
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.
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.
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.
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.
2020 年 4 月，英国政府实施了 NHS 检测和追踪计划，为公众提供 SARS-CoV-2 定量逆转录聚合酶链反应（qRT-PCR）检测，由经过培训的工作人员进行鼻喉拭子采样。自我采样（SS）将允许快速扩大检测能力和覆盖面。进行了六项研究，以确定 SS 是否与经过培训的工作人员进行的拭子取样一样有效检测 SARS-CoV-2。
2020 年 4 月至 10 月进行了六项前瞻性研究，使用六种拭子/介质组合。评估了辅助采样（AS）和 SS 之间的一致性、阳性率、敏感性、循环阈值（Ct）值和无效率差异。使用 95%置信区间（CI）、配对 t 检验和基于模型的方法进行统计分析。
总体而言，共招募了 3253 人（中位数年龄 37 岁，49%为女性），其中 2933 人具有有效的配对 qRT-PCR 结果。汇总一致性率为 98%（95%CI：96%，99%）。SS（8.1%）和 AS（8.4%）的阳性率差异以及 SS（86%；95%CI：78%，92%）和 AS（91%；95%CI：78%，96%）之间的汇总敏感性差异均无统计学意义。两种类型的拭子均导致汇总无效率低于 2%，并且 Ct 值相关性很强。年龄、性别和先前的拭子采样经验对一致性或敏感性没有显著影响。
英国根据数据表明 SS 与 AS 等效，制定了促进 SARS-CoV-2 自我检测的政策。SS 的阳性结果可能适用于其他呼吸道病原体的检测，我们认为自我采样和自我检测对于未来的大流行准备至关重要。
