Servicio de Virus Oncogénicos, Departamento de Virología, Instituto Nacional de Enfermedades Infecciosas-ANLIS Dr. Carlos G. Malbrán, Ciudad Autónoma de Buenos Aires 1282AFF, Argentina.
Servicio de Neurovirosis, Departamento de Virología, Instituto Nacional de Enfermedades Infecciosas-ANLIS Dr. Carlos G. Malbrán, Ciudad Autónoma de Buenos Aires 1282AFF, Argentina.
Genes (Basel). 2021 Apr 28;12(5):659. doi: 10.3390/genes12050659.
Our aim was to evaluate the analytical and clinical performance of the SARS-CoV-2 molecular detection kits used in Argentina. Nine real-time reverse-transcription polymerase chain reaction (RT-qPCR) and three reverse-transcription loop-mediated isothermal amplification (RT-LAMP) assays were evaluated using the World Health Organization (WHO) recommended test as reference method. A secondary standard calibrated for the E, N and RdRp genes against the Pan American Health Organization-World Health Organization-International Standard was used to calculate the limit of detection (LoD). A panel of artificial clinical samples, 32 positive and 30 negative for SARS-CoV-2, were analyzed to estimate the kappa concordance (κ) and the diagnostic performance. Differences among the LoD values for the target genes amplified by each kit were >1 log copies/reaction. The κ for the RT-qPCR kits was greater than 0.9, whereas that for the RT-LAMP assays ranged from 0.75 to 0.93. The clinical performance of RT-qPCR kits showed 100% specificity and high sensitivity, although with variations according to the gene analyzed. The E and N genes provided greater clinical sensitivity, whereas the RdRp gene increased the clinical specificity. The RT-LAMP assays revealed a variable diagnostic performance. The information provided can be useful to choose the most appropriate diagnostic test and may contribute to the establishment of a consensus in the diagnosis of SARS-CoV-2 in Argentina and the region.
我们的目的是评估在阿根廷使用的 SARS-CoV-2 分子检测试剂盒的分析和临床性能。使用世界卫生组织（WHO）推荐的检测方法作为参考方法，评估了 9 种实时逆转录聚合酶链反应（RT-qPCR）和 3 种逆转录环介导等温扩增（RT-LAMP）检测试剂盒。使用针对 E、N 和 RdRp 基因并经泛美卫生组织-世界卫生组织-国际标准校准的二级标准品来计算检测限（LoD）。分析了一组 32 个 SARS-CoV-2 阳性和 30 个 SARS-CoV-2 阴性的人工临床样本，以估计kappa 一致性（κ）和诊断性能。每个试剂盒扩增的目标基因的 LoD 值之间的差异>1 个对数拷贝/反应。RT-qPCR 试剂盒的κ大于 0.9，而 RT-LAMP 检测试剂盒的κ范围为 0.75 至 0.93。RT-qPCR 试剂盒的临床性能具有 100%的特异性和高灵敏度，但根据分析的基因有所不同。E 和 N 基因提供了更高的临床灵敏度，而 RdRp 基因提高了临床特异性。RT-LAMP 检测试剂盒显示出可变的诊断性能。提供的信息可能有助于选择最合适的诊断检测方法，并有助于在阿根廷和该地区建立 SARS-CoV-2 的诊断共识。
