A highly effective reverse-transcription loop-mediated isothermal amplification (RT-LAMP) assay for the rapid detection of SARS-CoV-2 infection.
A highly effective reverse-transcription loop-mediated isothermal amplification (RT-LAMP) assay for the rapid detection of SARS-CoV-2 infection.
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DOI：
10.1016/j.jinf.2020.10.039
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发表时间：
2021-01
期刊：
影响因子：
--
通讯作者：
Kidd SP
中科院分区：
文献类型：
--
作者：
Fowler VL;Armson B;Gonzales JL;Wise EL;Howson ELA;Vincent-Mistiaen Z;Fouch S;Maltby CJ;Grippon S;Munro S;Jones L;Holmes T;Tillyer C;Elwell J;Sowood A;de Peyer O;Dixon S;Hatcher T;Patrick H;Laxman S;Walsh C;Andreou M;Morant N;Clark D;Moore N;Houghton R;Cortes NJ;Kidd SP
新冠肺炎大流行说明了简单、快速和准确的诊断检测的重要性。这项研究描述了一种新的SARS-CoV-2 RT-LAMP快速检测方法的有效性，用于提取的RNA或直接从拭子中提取，提供了一种不依赖于大流行期间经常短缺的传统试剂的替代诊断途径。该RT-LAMP方法的分析特异度为100%，分析灵敏度为1 × 10 1~1 × 10 2拷贝。与CARE标准相比，RNA RT-LAMP的诊断敏感性(DSE)和特异性(DSP)分别为97%和99%。当使用CT值为33时，越来越多的证据表明，患者感染病毒的风险很低，诊断的敏感度为100%。不需要提取RNA的Direct RT-LAMP的DSE和DSP分别为67%和97%。当设定≤33和≤25的CT截止值时，DSE分别增加到75%和100%，从拭子到结果CT<；25的时间是<；15分钟。我们建议，RNA RT-LAMP可以在需要增加样本吞吐量的情况下取代RRT-PCR，并且Direct RT-LAMP作为一种近患者筛查工具，在疾病流行增加的时候快速识别急诊科和疗养院的高传染性个人，确保阴性结果仍然得到实验室确认。
The COVID-19 pandemic has illustrated the importance of simple, rapid and accurate diagnostic testing. This study describes the validation of a new rapid SARS-CoV-2 RT-LAMP assay for use on extracted RNA or directly from swab offering an alternative diagnostic pathway that does not rely on traditional reagents that are often in short supply during a pandemic. Analytical specificity (ASp) of this new RT-LAMP assay was 100% and analytical sensitivity (ASe) was between 1 × 101 and 1 × 102 copies per reaction when using a synthetic DNA target. The overall diagnostic sensitivity (DSe) and specificity (DSp) of RNA RT-LAMP was 97% and 99% respectively, relative to the standard of care rRT-PCR. When a CT cut-off of 33 was employed, above which increasingly evidence suggests there is a low risk of patients shedding infectious virus, the diagnostic sensitivity was 100%. The DSe and DSp of Direct RT-LAMP (that does not require RNA extraction) was 67% and 97%, respectively. When setting CT cut-offs of ≤33 and ≤25, the DSe increased to 75% and 100%, respectively, time from swab-to-result, CT < 25, was < 15 min. We propose that RNA RT-LAMP could replace rRT-PCR where there is a need for increased sample throughput and Direct RT-LAMP as a near-patient screening tool to rapidly identify highly contagious individuals within emergency departments and care homes during times of increased disease prevalence ensuring negative results still get laboratory confirmation.
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