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自我采样与辅助采样用于 qRT-PCR 检测病毒:基于在英国进行的六项前瞻性设计评估的荟萃分析,针对 SARS-CoV-2 的经验。

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.

机构信息

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.

出版信息

Eur J Clin Microbiol Infect Dis. 2024 Aug;43(8):1621-1630. doi: 10.1007/s10096-024-04866-z. Epub 2024 Jun 10.


DOI:10.1007/s10096-024-04866-z
PMID:38856828
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11271363/
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.

摘要

目的: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。

方法: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。

结果: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。

结论: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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c22c/11271363/6d9fbe983d8b/10096_2024_4866_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c22c/11271363/2abeb9fccbea/10096_2024_4866_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c22c/11271363/eb41ca03d3c2/10096_2024_4866_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c22c/11271363/1a9d911885a7/10096_2024_4866_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c22c/11271363/6d9fbe983d8b/10096_2024_4866_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c22c/11271363/2abeb9fccbea/10096_2024_4866_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c22c/11271363/eb41ca03d3c2/10096_2024_4866_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c22c/11271363/1a9d911885a7/10096_2024_4866_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c22c/11271363/6d9fbe983d8b/10096_2024_4866_Fig4_HTML.jpg

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引用本文的文献

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Acceptability of self-sampling and self-testing for infections: a rapid systematic review on public users' views.

BMC Public Health. 2025-2-20

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J Assoc Med Microbiol Infect Dis Can. 2024-1-16

[2]
Comparable performance of antigen-detecting rapid test by healthcare worker-collected and self-collected swabs for SARS-CoV-2 diagnostic: A systematic review and meta-analysis.

Rev Med Virol. 2024-1

[3]
Review of HIV Self Testing Technologies and Promising Approaches for the Next Generation.

Biosensors (Basel). 2023-2-20

[4]
Testing Technologies as Enhancers of Disease Intervention Specialist Activities: Applying Lessons From COVID-19.

Sex Transm Dis. 2023-8-1

[5]
Combined nasal- and oropharyngeal self-swab provides equivalent performance compared to professionally collected oropharyngeal swabs in detecting SARS-CoV-2 in a real-life setting.

J Virol Methods. 2023-3

[6]
Diagnostic Performance, Stability, and Usability of Self-Collected Combo Swabs and Saliva for Coronavirus Disease 2019 Diagnosis: A Case-Control Study.

Infect Chemother. 2022-9

[7]
Concordance of SARS-CoV-2 Results in Self-collected Nasal Swabs vs Swabs Collected by Health Care Workers in Children and Adolescents.

JAMA. 2022-9-13

[8]
Diagnostic performance of patient self-collected oral swab (tongue and cheek) in comparison with healthcare worker-collected nasopharyngeal swab for severe acute respiratory syndrome coronavirus-2 detection.

APMIS. 2022-11

[9]
Detection of SARS-CoV-2 RNA by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) on Self-Collected Nasal Swab Compared With Professionally Collected Nasopharyngeal Swab.

Cureus. 2022-6-3

[10]
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