Diagnostic performance of a colorimetric RT -LAMP for the identification of SARS-CoV-2: A multicenter prospective clinical evaluation in sub-Saharan Africa.-猫眼课题宝

DOI：

10.1016/j.eclinm.2021.101101

发表时间：

2021-10

期刊：

EClinicalMedicine

影响因子：

15.1

通讯作者：

中科院分区：

医学1区

文献类型：

作者：

Baba MM;Bitew M;Fokam J;Lelo EA;Ahidjo A;Asmamaw K;Beloumou GA;Bulimo WD;Buratti E;Chenwi C;Dadi H;D'Agaro P;De Conti L;Fainguem N;Gadzama G;Maiuri P;Majanja J;Meshack W;Ndjolo A;Nkenfou C;Oderinde BS;Opanda SM;Segat L;Stuani C;Symekher SL;Takou D;Tesfaye K;Triolo G;Tuki K;Zacchigna S;Marcello A

来源链接：

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8401528/

管理和控制由严重急性呼吸综合征冠状病毒SARS-CoV-2引起的新冠肺炎大流行至关重要地依赖于在临床标本中快速和可靠地识别该病毒。用比色法反转录环介导的等温扩增(RT-LAMP)检测病毒RNA是一种简单、可靠和经济的分析方法，可在资源有限的环境中部署。我们的目的是评估RT-LAMP在RLS中的本征和外在性能。这是一项关于诊断准确性的多中心前瞻性观察研究，于2020年10月至2021年2月在四个非洲国家进行：喀麦隆、埃塞俄比亚、肯尼亚和尼日利亚；以及意大利。我们招募了1657名新冠肺炎疑似病例或无症状患者进行筛查。从咽拭子中提取的RNA用比色法RT-LAMP和标准的实时聚合酶链式反应(RT-PCR)平行检测。对1657份来自感染者的预期样本进行RT-LAMP和标准RT-PCR比较，以确定其敏感性和特异性。对于在不同国家进行完全相同程序的1292个样本的子集，我们获得了非常高的特异度(98%)和阳性预测值(PPV=10.99%)，而敏感度为87%，阴性预测值NPV=10.70%，RT-PCR数据分层显示，当RT-PCR循环阈值(Ct)低于35(97%)时，敏感度更高，高于35的敏感度降至60%。在这项现场试验中，RT-LAMP似乎是一种可靠的检测方法，可与RT-PCR相媲美，特别是在病毒载量中等到高的情况下(CT&lt；35)。因此，RT-LAMP可以部署在RLS中，在不影响输出质量的情况下对新冠肺炎进行及时管理和预防。比尔和梅琳达·盖茨基金会[赠款编号：Inv-022,816]。

Management and control of the COVID-19 pandemic caused by the severe acute respiratory syndrome coronavirus SARS-CoV-2 is critically dependent on quick and reliable identification of the virus in clinical specimens. Detection of viral RNA by a colorimetric reverse transcription loop-mediated isothermal amplification (RT-LAMP) is a simple, reliable and cost-effective assay, deployable in resource-limited settings (RLS). Our objective was to evaluate the intrinsic and extrinsic performances of RT-LAMP in RLS. This is a multicenter prospective observational study of diagnostic accuracy, conducted from October 2020 to February 2021 in four African Countries: Cameroon, Ethiopia, Kenya and Nigeria; and in Italy. We enroled 1657 individuals who were either COVID-19 suspect cases, or asymptomatic and presented for screening. RNA extracted from pharyngeal swabs was tested in parallel by a colorimetric RT-LAMP and by a standard real time polymerase chain reaction (RT-PCR). The sensitivity and specificity of index RT LAMP compared to standard RT-PCR on 1657 prospective specimens from infected individuals was determined. For a subset of 1292 specimens, which underwent exactly the same procedures in different countries, we obtained very high specificity (98%) and positive predictive value (PPV = 99%), while the sensitivity was 87%, with a negative predictive value NPV = 70%, Stratification of RT-PCR data showed superior sensitivity achieved with an RT-PCR cycle threshold (Ct) below 35 (97%), which decreased to 60% above 35. In this field trial, RT-LAMP appears to be a reliable assay, comparable to RT-PCR, particularly with medium-high viral loads (Ct < 35). Hence, RT-LAMP can be deployed in RLS for timely management and prevention of COVID-19, without compromising the quality of output. Bill & Melinda Gates Foundation [Grant No. INV-022,816].