Allplex™2019-nCoV和TaqPath™COVID-19检测方法的比较

IF 0.8 Q3 MEDICINE, GENERAL & INTERNAL
M. Colosimo, P. Minchella, Rossana Tallerico, Ilenia Talotta, C. Peronace, L. Gallelli, G. Di Mizio, E. Cione
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引用次数: 3

摘要

COVID-19的临床表现是非特异性的,为了改善和限制SARS-CoV-2病毒的传播,需要使用可靠的方法进行准确诊断。对500份鼻咽拭子标本进行了SARS-CoV-2检测。其中,184份样品在全自动Allplex™2019-nCoV检测中呈阳性。所有阳性样本用半自动化的TaqPath™COVID-19 CE-IVD RT-PCR试剂盒(之后称为TaqPath™COVID-19)重新检测。SARS-CoV-2基因靶点的RT-qPCR比较显示,只有一个共同的靶点,即N基因。因此,采用N基因对两种检测方法进行比较。我们注意到测试之间的Ct值不同。因此,根据Ct值结果将样品分为四组:(1)Ct < 25, (2) Ct 25 - 30, (3) Ct 30-35, (4) Ct > - 35。TaqPath™COVID-19试剂盒再次确认了Allplex™2019-nCoV检测的结果。总之,Allplex™2019-nCoV检测和TaqPath™COVID-19检测均能准确确诊SARS-CoV-2感染。即使TaqPath™COVID-19具有半自动化的工作流程,它也不会在SARS-CoV-2的诊断筛选中引入偏见,并且它支持间接识别相关变体以进行测序。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparison of Allplex™ 2019-nCoV and TaqPath™ COVID-19 Assays
The clinical presentation of COVID-19 is non-specific, and to improve and limit the spread of the SARS-CoV-2 virus, an accurate diagnosis with a robust method is needed. A total of 500 nasopharyngeal swab specimens were tested for SARS-CoV-2. Of these, 184 samples were found to be positive with Allplex™ 2019-nCoV Assay, which is fully automated. All the positive samples were retested with TaqPath™ COVID-19 CE-IVD RT-PCR Kit (after this, referred to as TaqPath™ COVID-19), semi-automated. The comparison of RT-qPCR for SARS-CoV-2 genes target points shows only one target point in common, the N gene. Therefore, the N gene was used to compare both assays. We noticed different Ct values between the tests. Therefore, samples were divided into four groups depending to the Ct value results: (1) Ct < 25, (2) Ct 25–30, (3) Ct 30–35, (4) Ct > 35. TaqPath™ COVID-19 Kit reconfirmed the results obtained from Allplex™ 2019-nCoV Assay. In conclusion, both the Allplex™ 2019-nCoV assay and TaqPath™ COVID-19 tests accurately confirm the diagnosis of SARS-CoV-2 infection. Even if TaqPath™ COVID-19 has a semi-automated workflow, it does not introduce bias in the diagnostic screening of SARS-CoV-2, and it supports the indirect identification of variants of concern to undergo sequencing.
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