A prospective diagnostic evaluation of accuracy of self-taken and healthcare worker-taken swabs for rapid COVID-19 testing.
A prospective diagnostic evaluation of accuracy of self-taken and healthcare worker-taken swabs for rapid COVID-19 testing.
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DOI：
10.1371/journal.pone.0270715
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发表时间：
2022
期刊：
影响因子：
3.7
通讯作者：
中科院分区：
文献类型：
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作者：
世卫组织建议为床边检测 SARS-CoV-2 抗原而开发的快速诊断测试 (RDT) 使用经过培训的卫生保健人员来收集样本。我们假设自取样本与 RDT 一起用于诊断 COVID-19 并不逊色。我们设计了一项前瞻性诊断评估，比较了自己采集的咽拭子和医护人员 (HCW) 采集的咽喉/鼻拭子来执行 SARS-CoV-2 的 RDT，以及这些拭子与 RT-PCR 的比较。年满 18 岁且有 COVID-19 症状的合格参与者。在 NHS Test and Trace 免下车社区 PCR 检测站（英国利物浦）招募了 250 名参与者；一名在分析前退出。收集用于 Covios® RDT 的自我管理咽喉/鼻拭子、经过培训的医护人员采集的咽喉/鼻拭子用于 PCR 以及用于 RDT 的 HCW 比较咽喉/鼻拭子。将 RDT 结果与作为参考标准的 RT-PCR 进行比较，以计算敏感性和特异性。 75 名参与者 (75/249, 30.1%) RT-PCR 呈阳性。使用自行采集的拭子进行的 RDT 的敏感性为 90.5%（67/74，95% CI：83.9–97.2），而使用医护人员采集的拭子进行的 RDT 的敏感性为 78.4%（58/74，95% CI：69.0–87.8）（绝对差异 12.2%，95% CI：4.7–19.6， p = 0.003）。自行采集的拭子的特异性为 99.4%（173/174，95% CI：98.3–100.0），而医护人员采集的拭子的特异性为 98.9%（172/174，95% CI：97.3–100.0）（绝对差异 0.6%，95% CI：0.5–1.7，p = 0.317）。自行采取的 RDT（98.5%、67/68、95% CI：95.7-100.0）和医护人员采取的 RDT（96.7%、58/60、95% CI 92.1-100.0）的 PPV 没有显着差异（p = 0.262）。然而，自己采集的拭子 RDT 的 NPV 显着高于医护人员采集的 RDT（91.5%、172/188、95% CI 87.5-95.5，p = 0.003）（96.1%、173/180、95% CI：93.2-98.9）。总之，用于 COVID-19 检测的自取拭子为用于 RDT 的医护人员采集拭子提供了准确的替代方案。我们的结果表明，在没有培训的情况下，非专业人士可以使用自己采集的喉咙/鼻腔样本作为有症状成年人快速检测计划的一部分。当缺乏训练有素的医护人员限制了检测机会时，这一点尤其重要。
Rapid diagnostic tests (RDTs) developed for point of care detection of SARS-CoV-2 antigen are recommended by WHO to use trained health care workers to collect samples. We hypothesised that self-taken samples are non-inferior for use with RDTs to diagnose COVID-19. We designed a prospective diagnostic evaluation comparing self-taken and healthcare worker (HCW)-taken throat/nasal swabs to perform RDTs for SARS-CoV-2, and how these compare to RT-PCR. Eligible participants 18 years or older with symptoms of COVID-19. 250 participants recruited at the NHS Test and Trace drive-through community PCR testing site (Liverpool, UK); one withdrew before analysis. Self-administered throat/nasal swab for the Covios® RDT, a trained HCW taken throat/nasal sample for PCR and HCW comparison throat/nasal swab for RDT were collected. RDT results were compared to RT-PCR, as the reference standard, to calculate sensitivity and specificity. Seventy-five participants (75/249, 30.1%) were positive by RT-PCR. RDTs with self-taken swabs had a sensitivity of 90.5% (67/74, 95% CI: 83.9–97.2), compared to 78.4% (58/74, 95% CI: 69.0–87.8) for HCW-taken swabs (absolute difference 12.2%, 95% CI: 4.7–19.6, p = 0.003). Specificity for self-taken swabs was 99.4% (173/174, 95% CI: 98.3–100.0), versus 98.9% (172/174, 95% CI: 97.3–100.0) for HCW-taken swabs (absolute difference 0.6%, 95% CI: 0.5–1.7, p = 0.317). The PPV of self-taken RDTs (98.5%, 67/68, 95% CI: 95.7–100.0) and HCW-taken RDTs (96.7%, 58/60, 95% CI 92.1–100.0) were not significantly different (p = 0.262). However, the NPV of self-taken swab RDTs was significantly higher (96.1%, 173/180, 95% CI: 93.2–98.9) than HCW-taken RDTs (91.5%, 172/188, 95% CI 87.5–95.5, p = 0.003). In conclusion, self-taken swabs for COVID-19 testing offer an accurate alternative to healthcare worker taken swabs for use with RDTs. Our results demonstrate that, with no training, self-taken throat/nasal samples can be used by lay individuals as part of rapid testing programmes for symptomatic adults. This is especially important where the lack of trained healthcare workers restricts access to testing.
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DOI：
10.1136/bmj.n1637
发表时间：
2021-07-06
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
García-Fiñana M;Hughes DM;Cheyne CP;Burnside G;Stockbridge M;Fowler TA;Fowler VL;Wilcox MH;Semple MG;Buchan I
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Buchan I
影响因子：
15.1
作者：
Peto T;UK COVID-19 Lateral Flow Oversight Team
通讯作者：
UK COVID-19 Lateral Flow Oversight Team
DOI：
10.1016/j.jcv.2021.104874
发表时间：
2021-08
期刊：
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
影响因子：
--
作者：
Lindner AK;Nikolai O;Rohardt C;Kausch F;Wintel M;Gertler M;Burock S;Hörig M;Bernhard J;Tobian F;Gaeddert M;Lainati F;Corman VM;Jones TC;Sacks JA;Seybold J;Denkinger CM;Mockenhaupt FP
通讯作者：
Mockenhaupt FP
影响因子：
4.4
作者：
Buderer, NMF
通讯作者：
Buderer, NMF