一种比色法新冠病毒逆转录环介导等温扩增检测方法相对于逆转录聚合酶链反应的临床验证与评估
Clinical Validation and Evaluation of a Colorimetric SARS-CoV-2 RT-LAMP Assay Against RT-PCR.
作者信息
Erdem Murat, Andaç-Özketen Ayşe, Özketen Ahmet Çağlar, Karahan Gizem, Tozluyurt Abdullah, Palaz Fahreddin, Alp Alpaslan, Ünal Serhat
机构信息
Department of Molecular Biology and Genetics, Middle East Technical University, Ankara, Turkey.
Department of Basic Sciences, TED University, Ankara, Turkey.
出版信息
Infect Dis Clin Microbiol. 2023 Jun 23;5(2):136-143. doi: 10.36519/idcm.2023.210. eCollection 2023 Jun.
OBJECTIVE
Reverse transcriptase loop-mediated isothermal amplification (RT-LAMP) is one of the time-saving, accurate, and cost-effective alternative methods to real-time polymerase chain reaction (RT-PCR). This study aimed to identify the robustness of a colorimetric RT-LAMP assay kit that we developed, detecting SARS-COV-2 viral RNA within 30 minutes using a primer set special to the N gene against RT-PCR, the gold standard.
MATERIALS AND METHODS
Both symptomatic and asymptomatic subjects were included from a single university hospital and the status of both RT-PCR and RT-LAMP assay results were compared, and the consistency of these two assays was analyzed.
RESULTS
We showed that the RT-LAMP and RT-PCR assay results confirmed 90% consistency. When we consider the epidemiologic, clinical, and radiologic evaluation, the consistency reached 97%.
CONCLUSION
The results revealed that the colorimetric RT-LAMP assay was efficient, robust, and rapid to be used as in vitro diagnostic tool to display competitiveness compared with RT-PCR.
目的
逆转录环介导等温扩增技术（RT-LAMP）是一种省时、准确且经济高效的替代实时聚合酶链反应（RT-PCR）的方法。本研究旨在鉴定我们开发的一种比色RT-LAMP检测试剂盒的稳健性，该试剂盒使用针对N基因的引物组，在30分钟内检测严重急性呼吸综合征冠状病毒2（SARS-CoV-2）病毒RNA，并与金标准RT-PCR进行比较。
材料与方法
纳入来自一家大学医院的有症状和无症状受试者，比较RT-PCR和RT-LAMP检测结果的状况，并分析这两种检测方法的一致性。
结果
我们发现RT-LAMP和RT-PCR检测结果的一致性为90%。当我们考虑流行病学、临床和影像学评估时，一致性达到97%。
结论
结果表明，与RT-PCR相比，比色RT-LAMP检测作为一种体外诊断工具，高效、稳健且快速，具有竞争力。
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