Reverse-Transcription Loop-Mediated Isothermal Amplification Has High Accuracy for Detecting Severe Acute Respiratory Syndrome Coronavirus 2 in Saliva and Nasopharyngeal/Oropharyngeal Swabs from Asymptomatic and Symptomatic Individuals.
Reverse-Transcription Loop-Mediated Isothermal Amplification Has High Accuracy for Detecting Severe Acute Respiratory Syndrome Coronavirus 2 in Saliva and Nasopharyngeal/Oropharyngeal Swabs from Asymptomatic and Symptomatic Individuals.
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DOI：
10.1016/j.jmoldx.2021.12.007
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发表时间：
2022-04
期刊：
影响因子：
--
通讯作者：
Fowler VL
中科院分区：
文献类型：
--
作者：
Kidd SP;Burns D;Armson B;Beggs AD;Howson ELA;Williams A;Snell G;Wise EL;Goring A;Vincent-Mistiaen Z;Grippon S;Sawyer J;Cassar C;Cross D;Lewis T;Reid SM;Rivers S;James J;Skinner P;Banyard A;Davies K;Ptasinska A;Whalley C;Ferguson J;Bryer C;Poxon C;Bosworth A;Kidd M;Richter A;Burton J;Love H;Fouch S;Tillyer C;Sowood A;Patrick H;Moore N;Andreou M;Morant N;Houghton R;Parker J;Slater-Jefferies J;Brown I;Gretton C;Deans Z;Porter D;Cortes NJ;Douglas A;Hill SL;Godfrey KM;Fowler VL
先前的研究描述了逆转录环介导等温扩增（RT-LAMP）用于快速检测鼻咽/口咽拭子和唾液样本中的严重急性呼吸综合征冠状病毒2（SARS-CoV-2）。该多中心临床评价描述了用于无提取RT-LAMP的改进样品制备方法的验证，并报告了用于SARS-CoV-2检测的四种RT-LAMP检测形式的临床性能。对559份拭子和86，760份唾液样本进行了直接RT-LAMP，并对来自医疗保健和社区环境中无症状和有症状个体的12，619份拭子和12，521份唾液样本提取的RNA进行了RNA RT-LAMP。直接RT-LAMP的总诊断敏感性（DSe）为70.35%（95% CI，63.48%-76.60%），84.62%（95%CI，79.50%-88.88%），诊断特异性为100%（95% CI，98.98%-100.00%）和100%（95%CI，99.72%~ 100.00%）;分析RT-qPCR ORF 1ab CT值≤25和≤33的样品，DSe值为100%拭子和唾液的阳性率分别为99.01%（95%CI，94.61%-99.97%）和87.61%（95%CI，82.69%-91.54%）。RNA RT-LAMP的总DSe和诊断特异性为96.06%（95% CI，92.88%-98.12%）和99.99%拭子和唾液的阳性率分别为80.65%（95% CI，73.54%-86.54%）和99.99%（95% CI，99.95%-100%）。这些发现表明，RT-LAMP适用于各种用例，包括来自无症状个体的唾液的频繁的、基于间隔的直接RT-LAMP，否则单独使用症状测试可能会遗漏这些个体。
Previous studies have described reverse-transcription loop-mediated isothermal amplification (RT-LAMP) for the rapid detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal/oropharyngeal swab and saliva samples. This multisite clinical evaluation describes the validation of an improved sample preparation method for extraction-free RT-LAMP and reports clinical performance of four RT-LAMP assay formats for SARS-CoV-2 detection. Direct RT-LAMP was performed on 559 swabs and 86,760 saliva samples and RNA RT-LAMP on extracted RNA from 12,619 swabs and 12,521 saliva samples from asymptomatic and symptomatic individuals across health care and community settings. For direct RT-LAMP, overall diagnostic sensitivity (DSe) was 70.35% (95% CI, 63.48%–76.60%) on swabs and 84.62% (95% CI, 79.50%–88.88%) on saliva, with diagnostic specificity of 100% (95% CI, 98.98%–100.00%) on swabs and 100% (95% CI, 99.72%–100.00%) on saliva, compared with quantitative RT-PCR (RT-qPCR); analyzing samples with RT-qPCR ORF1ab CT values of ≤25 and ≤33, DSe values were 100% (95% CI, 96.34%–100%) and 77.78% (95% CI, 70.99%–83.62%) for swabs, and 99.01% (95% CI, 94.61%–99.97%) and 87.61% (95% CI, 82.69%–91.54%) for saliva, respectively. For RNA RT-LAMP, overall DSe and diagnostic specificity were 96.06% (95% CI, 92.88%–98.12%) and 99.99% (95% CI, 99.95%–100%) for swabs, and 80.65% (95% CI, 73.54%–86.54%) and 99.99% (95% CI, 99.95%–100%) for saliva, respectively. These findings demonstrate that RT-LAMP is applicable to a variety of use cases, including frequent, interval-based direct RT-LAMP of saliva from asymptomatic individuals who may otherwise be missed using symptomatic testing alone.
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影响因子：
3.1
作者：
Howson ELA;Kidd SP;Armson B;Goring A;Sawyer J;Cassar C;Cross D;Lewis T;Hockey J;Rivers S;Cawthraw S;Banyard A;Anderson P;Rahou S;Andreou M;Morant N;Clark D;Walsh C;Laxman S;Houghton R;Slater-Jefferies J;Costello P;Brown I;Cortes N;Godfrey KM;Fowler VL
通讯作者：
Fowler VL
影响因子：
9.4
作者：
Lee RA;Herigon JC;Benedetti A;Pollock NR;Denkinger CM
通讯作者：
Denkinger CM
影响因子：
3.1
作者：
Aydin S;Benk IG;Geckil AA
通讯作者：
Geckil AA
影响因子：
11.8
作者：
Bullard, Jared;Dust, Kerry;Poliquin, Guillaume
通讯作者：
Poliquin, Guillaume
DOI：
10.1007/s10096-020-03913-9
发表时间：
2020-04-27
影响因子：
4.5
作者：
La Scola, Bernard;Le Bideau, Marion;Raoult, Didier
通讯作者：
Raoult, Didier