ABSTRACT

COVID-19 pandemic has become a global public health priority. The rapid increase in infection numbers, along with a significant number of deaths, has made the virus a serious threat to human health. Rapid, reliable, and simple diagnostic methods are critical to controlling the disease. While Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is the current diagnostic gold standard, Reverse Transcriptase Loop-Mediated Isothermal Amplification (RT-LAMP) appears to be a compelling alternative diagnostic test due to its greater simplicity, shorter time to obtain a result, and lower cost. This study examined RT-LAMP application for rapid identification of SARS-CoV-2 infection compared to the RT-PCR assay. A systematic review and meta-analysis was conducted over six scientific databases in accordance with PRISMA guidelines. Original studies published in English conducted on human clinical samples were included. Articles evaluating the sensitivity and specificity of RT-LAMP relative to RT-PCR were considered eligible. Quality assessment of bias and applicability was examined based on QUADAS-2. A total of 351 studies were found based on the keywords and search queries. Fourteen eligible case–control studies fit the mentioned criteria. Quality assessment using QUADAS-2 indicated alow risk of bias for all included studies. All case studies, containing 2,112 samples, had acumulative sensitivity of 95.5% (CI 97.5% = 90.8–97.9%) and cumulative specificity of 99.5% (CI 97.5% = 97.7–99.9%). The RT-LAMP assay could be areliable alternative COVID-19 diagnostic method due to its reduced cost and processing time compared to RT-PCR. RT-LAMP could potentially be utilized during critical high-throughput and high-demand situations.

摘要

COVID-19 大流行已成为全球公共卫生的优先事项。感染人数迅速增加，死亡人数大量增加，该病毒对人类健康构成严重威胁。快速、可靠且简单的诊断方法对于控制该疾病至关重要。虽然逆转录酶聚合酶链反应 (RT-PCR) 是当前的诊断金标准，但逆转录酶环介导的等温扩增 (RT-LAMP) 似乎是一种引人注目的替代诊断测试，因为它更简单，获得结果的时间更短，并且成本更低。本研究检验了 RT-LAMP 与 RT-PCR 检测相比在快速识别 SARS-CoV-2 感染方面的应用。根据 PRISMA 指南，对六个科学数据库进行了系统回顾和荟萃分析。其中包括以英文发表的针对人类临床样本进行的原始研究。评估 RT-LAMP 相对于 RT-PCR 的敏感性和特异性的文章被认为是合格的。基于 QUADAS-2 检查偏倚和适用性的质量评估。根据关键词和搜索查询，总共找到了 351 项研究。十四项符合条件的病例对照研究符合上述标准。使用 QUADAS-2 进行的质量评估表明所有纳入研究的偏倚风险较低。所有案例研究均包含 2,112 个样本，累积敏感性为95.5%（CI 97.5% = 90.8–97.9%），累积特异性为99.5%（CI 97.5% = 97.7–99.9%）。RT-LAMP 检测可能是可靠的替代 COVID-19 诊断方法，因为与 RT-PCR 相比，其成本更低，处理时间更短。RT-LAMP 可以在关键的高通量和高需求情况下使用。