一种用于快速检测 SARS-CoV-2 的 RT-LAMP 方法，可有效阻断无症状 COVID-19 的传播。
A rapid RT-LAMP SARS-CoV-2 screening assay for collapsing asymptomatic COVID-19 transmission.
机构信息
Leicester Cancer Research Centre, Department of Genetics and Genome Biology, University of Leicester, Leicester, United Kingdom.
Leicester Molecular Diagnostics, Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.
出版信息
PLoS One. 2022 Sep 1;17(9):e0273912. doi: 10.1371/journal.pone.0273912. eCollection 2022.
PURPOSE
To demonstrate the diagnostic performance of rapid SARS-CoV-2 RT-LAMP assays, comparing the performance of genomic versus sub-genomic sequence target with subsequent application in an asymptomatic screening population.
METHODS
RT-LAMP diagnostic specificity (DSe) and sensitivity (DSe) was determined using 114 RT-PCR clinically positive and 88 RT-PCR clinically negative swab samples processed through the diagnostic RT-PCR service within the University Hospitals of Leicester NHS Trust. A swab-based RT-LAMP SARS-CoV-2 screening programme was subsequently made available to all staff and students at the University of Leicester (Autumn 2020), implemented to ISO 15189:2012 standards using NHS IT infrastructure and supported by University Hospital Leicester via confirmatory NHS diagnostic laboratory testing of RT-LAMP 'positive' samples.
RESULTS
Validation samples reporting a Ct < 20 were detected at 100% DSe and DSp, reducing to 95% DSe (100% DSp) for all samples reporting a Ct < 30 (both genomic dual sub-genomic assays). Advisory screening identified nine positive cases in 1680 symptom free individuals (equivalent to 540 cases per 100,000) with results reported back to participants and feed into national statistics within 48 hours.
CONCLUSION
This work demonstrates the utility of a rapid RT-LAMP assay for collapsing transmission of SARS-CoV-2 in an asymptomatic screening population.
目的
展示快速 SARS-CoV-2 RT-LAMP 检测方法的诊断性能，比较基因组与亚基因组序列靶标在随后应用于无症状筛查人群中的表现。
方法
使用在莱斯特大学医院 NHS 信托中通过诊断 RT-PCR 服务处理的 114 份临床 RT-PCR 阳性和 88 份临床 RT-PCR 阴性拭子样本，确定 RT-LAMP 诊断特异性（DSe）和敏感性（DSe）。随后，在莱斯特大学（2020 年秋季）为所有员工和学生提供了基于拭子的 RT-LAMP SARS-CoV-2 筛查计划，该计划按照 NHS IT 基础设施实施 ISO 15189:2012 标准，并由莱斯特大学医院通过 NHS 诊断实验室对 RT-LAMP“阳性”样本进行确认性测试提供支持。
结果
报告 Ct < 20 的验证样本的 DSe 和 DSp 为 100%，所有报告 Ct < 30 的样本（包括基因组双亚基因组检测）的 DSe 降低至 95%（DSe 为 100%）。咨询性筛查在 1680 名无症状个体中发现了 9 例阳性病例（相当于每 100,000 例中有 540 例），结果在 48 小时内向参与者报告并纳入国家统计数据。
结论
这项工作证明了快速 RT-LAMP 检测方法在无症状筛查人群中用于抑制 SARS-CoV-2 传播的实用性。
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