评估九种商业 RT-PCR 试剂盒在哥伦比亚检测 SARS-CoV-2 的诊断性能。
Evaluation of the diagnostic performance of nine commercial RT-PCR kits for the detection of SARS-CoV-2 in Colombia.
机构信息
Centro de Investigaciones en Microbiología y Biotecnología-UR (CIMBIUR), Facultad de Ciencias Naturales, Universidad del Rosario, Bogotá, Colombia.
Instituto Nacional de Salud, Bogotá, Colombia.
出版信息
J Med Virol. 2021 Sep;93(9):5618-5622. doi: 10.1002/jmv.27051. Epub 2021 May 3.
Abstract
The ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has led to the design and development of multiple reverse-transcription polymerase chain reaction kits aimed to facilitate the rapid scale-up of molecular testing for massive screening. We evaluated the diagnostic performance of nine commercial kits, which showed optimal performance and high discriminatory power. However, we observed differences in terms of sensitivity, specificity, and E gene Ct Values and discuss these results in light of the influence of SARS-CoV-2 genetic variability and its potential impact in current molecular diagnostic assays.
摘要
持续的严重急性呼吸系统综合症冠状病毒 2（SARS-CoV-2）大流行导致了多种逆转录聚合酶链反应试剂盒的设计和开发，旨在促进大规模筛选的分子检测的快速扩展。我们评估了 9 种商业试剂盒的诊断性能，这些试剂盒表现出最佳性能和高区分能力。然而，我们观察到在灵敏度、特异性和 E 基因 Ct 值方面存在差异，并根据 SARS-CoV-2 遗传变异性及其对当前分子诊断检测的潜在影响讨论了这些结果。
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