Departamento Laboratorio Central, Ministerio de Salud de la Provincia de Córdoba, Tránsito Cáceres de Allende 421, Córdoba, Argentina.
Centro de Investigaciones en Bioquímica Clínica e Inmunología (CIBICI), CONICET, Facultad de Ciencias Químicas, Universidad Nacional de Córdoba, Av. Medina Allende, X5000 HUA, Córdoba, Argentina.
Rev Argent Microbiol. 2023 Jul-Sep;55(3):206-213. doi: 10.1016/j.ram.2023.01.004. Epub 2023 Mar 6.
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.
新冠肺炎病例数量的飙升凸显了诊断检测在医疗和公共卫生决策中的关键作用，这些决策旨在控制和减轻 SARS-CoV-2 大流行。本研究报告了在阿根廷中部地区对不同的 SARS-CoV-2 分子检测方法进行评估和实施的情况。我们评估了 3 种实时 RT-PCR 试剂盒（GeneFinder COVID-19 Plus RealAmp Kit、DisCoVery SARS-CoV-2 RT-PCR Detection Kit 和 WGene SARS-CoV-2 RT Detection）、2 种核酸提取方法[MagaBio plus Virus DNA/RNA Purification Kit II（BioFlux），35 分钟与 9 分钟]、一种预分析试剂（FlashPrep®）和 2 种等温扩增检测方法（Neokit Plus 和 ELA CHEMSTRIP®）。根据评估的 3 种实时 RT-PCR 试剂盒的最佳性能排序为：DisCoVery>GeneFinderTM>WGene。这两种 RNA 提取方法显示出相似的良好结果：由于其更快的性能，选择了 MagaBio plus Virus RNA Purification Kit II（BioFlux）9 分钟。FlashPrep®试剂显示出出色的直接 RNA 检测效果。等温扩增检测方法的灵敏度和特异性值（>80%）可接受，除了 Ct>30 的样本。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。这些替代检测方法被证明在不利的情况下、去中心化和不同的流行病学场景中可以接受，可用于快速准确地检测 SARS-CoV-2。
