One Health Research Group, Universidad de Las Americas, Quito, Ecuador.
Front Cell Infect Microbiol. 2021 Jun 10;11:630552. doi: 10.3389/fcimb.2021.630552. eCollection 2021.
BACKGROUND: Multiple RT-qPCR kits are available in the market for SARS-CoV-2 diagnosis, some of them with Emergency Use Authorization (EUA) by FDA or their country of origin agency, but many of them lack of proper clinical evaluation. OBJECTIVE: We evaluated the clinical performance of two Korean SARS-CoV-2 RT-PCR kits available in South America, AccuPower SARS-CoV-2 Multiplex RT-PCR kit (Bioneer, South Korea) and Allplex 2019-nCoV Assay (Seegene, South Korea), for RT-qPCR SARS-CoV-2 diagnosis using the CDC protocol as a gold standard. RESULTS: We found strong differences among both kits clinical performance and analytical sensitivity; while the Allplex 2019-nCoV Assay has sensitivity of 96.5% and an estimated limit of detection of 4,000 copies/ml, the AccuPower SARS-CoV-2 Multiplex RT-PCR kit has a sensitivity of 75.5% and limit of detection estimated to be bigger than 20,000 copies/ml. CONCLUSIONS: AccuPower SARS-CoV-2 Multiplex RT-PCR kit and Allplex 2019-nCoV Assay are both made in South Korea but EUA by Korean CDC was only granted to the later. Our results support that Korean CDC EUA should be considered as a quality control proxy for Korean SARS-CoV-2 RT-PCR kits prior to importation by developing countries to guarantee high sensitivity diagnosis.
背景:市场上有多种用于 SARS-CoV-2 诊断的实时 RT-qPCR 试剂盒,其中一些获得了 FDA 或原产国机构的紧急使用授权(EUA),但其中许多试剂盒缺乏适当的临床评估。
目的:我们评估了两种在南美可用的韩国 SARS-CoV-2 RT-PCR 试剂盒的临床性能,AccuPower SARS-CoV-2 多重 RT-PCR 试剂盒(Bioneer,韩国)和 Allplex 2019-nCoV 检测试剂盒(Seegene,韩国),使用 CDC 方案作为金标准进行 RT-qPCR SARS-CoV-2 诊断。
结果:我们发现这两种试剂盒的临床性能和分析灵敏度存在很大差异;虽然 Allplex 2019-nCoV 检测试剂盒的灵敏度为 96.5%,估计检测限为 4,000 拷贝/ml,但 AccuPower SARS-CoV-2 多重 RT-PCR 试剂盒的灵敏度为 75.5%,估计检测限大于 20,000 拷贝/ml。
结论:AccuPower SARS-CoV-2 多重 RT-PCR 试剂盒和 Allplex 2019-nCoV 检测试剂盒均在韩国制造,但韩国 CDC 仅对后者授予了 EUA。我们的结果支持在发展中国家进口之前,应将韩国 CDC EUA 视为韩国 SARS-CoV-2 RT-PCR 试剂盒的质量控制代理,以保证高灵敏度诊断。
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