用于 SARS-CoV-2 诊断的 Viasure（CerTest Biotec）和 2019-nCoV CDC（IDT）RT-qPCR 试剂盒的分析和临床比较。
Analytical and clinical comparison of Viasure (CerTest Biotec) and 2019-nCoV CDC (IDT) RT-qPCR kits for SARS-CoV2 diagnosis.
机构信息
One Health Research Group, Universidad de Las Americas, Quito, Ecuador.
Agencia de Regulación y Control de La Bioseguridad y Cuarentena para Galápagos, Puerto Ayora, Ecuador.
出版信息
Virology. 2021 Jan 15;553:154-156. doi: 10.1016/j.virol.2020.10.010. Epub 2020 Nov 18.
Abstract
BACKGROUND
Several RT-qPCR kits are available for SARS-CoV-2 diagnosis, some of them with Emergency Use Authorization (EUA) by FDA, but most of them lacking of proper evaluation studies due to covid19 emergency.
OBJECTIVE
We evaluated Viasure RT-qPCR kit (CerTest Biotec, Spain) for SARS-CoV-2 diagnosis using FDA EUA 2019-nCoV CDC kit (IDT, USA) as a gold standard.
RESULTS
Although we found the lack of RNA quality control probe as the main limitation for the Viasure kit, the sensitivity was 91.9% and the specificity was 100%. The limit of detection (LOD) was 2000 copies/mL and 1000 copies/mL for Viasure and IDT kits, respectively.
CONCLUSIONS
Viasure RT-qPCR kit is a reliable tool for SARS-CoV-2 diagnosis but improvement of an alternative RT-qPCR reaction for RNA extraction quality control as RNaseP is recommended.
摘要
背景
有几种 RT-qPCR 试剂盒可用于 SARS-CoV-2 诊断，其中一些获得了 FDA 的紧急使用授权 (EUA)，但由于 covid19 紧急情况，大多数试剂盒缺乏适当的评估研究。
目的
我们使用 FDA EUA 2019-nCoV CDC 试剂盒（IDT，美国）作为金标准，评估了 Viasure RT-qPCR 试剂盒（西班牙 CerTest Biotec）用于 SARS-CoV-2 诊断的性能。
结果
尽管我们发现 Viasure 试剂盒的主要局限性是缺少 RNA 质量控制探针，但它的灵敏度为 91.9%，特异性为 100%。Viasure 和 IDT 试剂盒的检测限（LOD）分别为 2000 拷贝/mL 和 1000 拷贝/mL。
结论
Viasure RT-qPCR 试剂盒是一种可靠的 SARS-CoV-2 诊断工具，但建议改进替代 RT-qPCR 反应以进行 RNA 提取质量控制，例如使用 RNaseP。
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