PDF(Pubmed)
Abstract：
The rocketing number of COVID-19 cases highlighted the critical role that diagnostic tests play in medical and public health decision-making to contain and mitigate the SARS-CoV-2 pandemic. This study reports the evaluation and implementation of different tests for the molecular detection of SARS-CoV-2 in the central region of Argentina. We evaluated 3 real time RT-PCR kits (GeneFinder COVID-19 Plus RealAmp Kit, DisCoVery SARS-CoV-2 RT-PCR Detection Kit and WGene SARS-CoV-2 RT Detection), 2 nucleic acid extraction methods [MagaBio plus Virus DNA/RNA Purification Kit II (BioFlux), 35-min vs. 9-min], a pre-analytical reagent (FlashPrep®) and 2 isothermal amplification tests (Neokit Plus and ELA CHEMSTRIP®). The order according to the best performance of the 3 real-time RT-PCR kits evaluated was: DisCoVery>GeneFinderTM>WGene. The 2 RNA extraction methods showed similar good results: MagaBio plus Virus RNA Purification Kit II (BioFlux) 9-min was selected due to its faster performance. FlashPrep® reagent showed excellent results to perform direct RNA detection. Isothermal amplification assays showed acceptable sensitivity and specificity values (>80%), except in samples with Ct>30. Our data show optimal real time RT-PCR kits and alternative molecular methods for SARS-CoV-2 diagnostic. These alternative assays proved to be acceptable for their use in adverse contexts, decentralization, and different epidemiological scenarios, for rapid and accurate SARS-CoV-2 detection.
摘要：
COVID-19病例的激增凸显了诊断测试在医疗和公共卫生决策中发挥的关键作用，以控制和减轻SARS-CoV-2大流行。本研究报告了在阿根廷中部地区对SARS-CoV-2进行分子检测的不同测试的评估和实施。我们评估了3种实时RT-PCR试剂盒(GeneFinderCOVID-19PlusRealAmpKit，DisCoVerySARS-CoV-2RT-PCR检测试剂盒和WGeneSARS-CoV-2RT检测），2种核酸提取方法[MagaBioplus病毒DNA/RNA纯化试剂盒II（BioFlux），35分钟vs.9-min],预分析试剂(FlashPrep®)和2等温扩增测试(NeokitPlus和ELACHEMSTRIP®)。根据所评估的3种实时RT-PCR试剂盒的最佳性能的顺序为:DisCoVery>GeneFinderTM>WGene。2种RNA提取方法显示出相似的良好结果：选择MagaBio加病毒RNA纯化试剂盒II（BioFlux）9分钟，因为其性能更快。FlashPrep®试剂显示出进行直接RNA检测的优异结果。等温扩增试验显示出可接受的灵敏度和特异性值（>80％），除了Ct>30的样品。我们的数据显示了SARS-CoV-2诊断的最佳实时RT-PCR试剂盒和替代分子方法。这些替代测定法被证明在不利情况下使用是可以接受的，权力下放，和不同的流行病学情景，用于快速准确地检测SARS-CoV-2。
