Diagnostic accuracy of LAMP versus PCR over the course of SARS-CoV-2 infection.

Diagnostic accuracy of LAMP versus PCR over the course of SARS-CoV-2 infection.
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DOI:
10.1016/j.ijid.2021.04.018
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发表时间:
2021-06
期刊:
International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases
影响因子:
--
通讯作者:
Doi Y
Doi Y
中科院分区:
其他
文献类型:
--
作者:
Inaba M;Higashimoto Y;Toyama Y;Horiguchi T;Hibino M;Iwata M;Imaizumi K;Doi Y

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逆转录环介导的等温扩增 (RT-LAMP) 已被验证可诊断多种病毒感染。然而,其在现实临床环境中检测 SARS-CoV-2 的诊断准确性仍不清楚。本研究旨在确定 RT-LAMP 与逆转录定量聚合酶链反应 (RT-qPCR) 相比在 COVID-19 病程中的诊断敏感性和特异性。通过 RT-LAMP 和 RT-qPCR 对从 24 名 COVID-19 患者获得的总共 124 份鼻咽拭子样本进行了检测。与 RT-qPCR 相比,RT-LAMP 的敏感性和特异性被分析为发病时间的函数。截至发病后第9天,RT-LAMP的阳性率为92.8%,与RT-qPCR相比,敏感性和特异性均为100%。然而,发病第10天后,RT-LAMP阳性率降至25%以下,两种方法阳性率一致性低于60%。 RT-LAMP 的检测限为 6.7 拷贝/反应。直到症状出现后第 9 天,RT-LAMP 的诊断准确性与 RT-qPCR 相同。这些研究结果表明,RT-LAMP 可用作 COVID-19 的诊断工具,作为 COVID-19 急性症状期 RT-qPCR 的替代方案。
Reverse transcription loop-mediated isothermal amplification (RT-LAMP) has been validated to diagnose several viral infections. However, its diagnostic accuracy in detecting SARS-CoV-2 in real-life clinical settings remains unclear. This study aimed to determine the diagnostic sensitivity and specificity of RT-LAMP compared to reverse transcription-quantitative polymerase chain reaction (RT-qPCR) over the disease course of COVID-19. A total of 124 nasopharyngeal swab samples obtained from 24 COVID-19 patients were tested by RT-LAMP and RT-qPCR. Sensitivities and specificities of RT-LAMP compared with RT-qPCR were analyzed as a function of time from onset. Up to the 9th day after onset, the RT-LAMP had a positivity of 92.8%, and the sensitivity and specificity compared with RT-qPCR was 100%. However, after the 10th day after onset, the positivity of RT-LAMP decreased to less than 25%, and the concordance of positivity between the two methods was below 60%. The limit of detection of RT-LAMP was 6.7 copies/reaction. Until the 9th day after the onset of symptoms, RT-LAMP had the same diagnostic accuracy as RT-qPCR. These findings suggest that RT-LAMP can be used as a diagnostic tool for COVID-19 as an alternative to RT-qPCR in the acute symptomatic phase of COVID-19.
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