A comparison study of GeneXpert and In-House N1N2 CDC Real-Time RT-PCR for detection of SARS-CoV-2 infection

A. Yasmon, Lola Febriana Dewi, F. Fithriyah, Ariyani Kiranasari, Andriansjah Rukmana, Y. Saharman, F. Ibrahim, P. Sudarmono
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Abstract

COVID-19 is a disease caused by SARS-CoV-2, a new virus from genus β-coronaviruses. This disease has been declared a pandemic by WHO on 11 March 2020 until now. The nucleic acid tests are the most frequently used assays because of their high sensitivity and specificity. One of the tests is the GeneXpert, a real-time reverse transcription polymerase chain reaction (rRT-PCR)-based assay platform. The use of the GeneXpert shows great public health interest because of the rapid (50 min), the minimum number of trained staff, and less infrastructure and equipment. However, there are limited data on the application of the GeneXpert for the detection of SARS-CoV-2. Therefore, we conducted a comparative study between the GeneXpert and in-house N1N2 CDC rRT-PCR assay. Of 86 samples, 17 were rRT-PCR positive while 13 were GeneXpert positive. Of rRT-PCR positive 17 samples, 7 were GeneXpert negative [58.82% (10/17] sensitivity]. We also found that 3 GeneXpert positive samples showed rRT-PCR negative (95.65% [66/69] specificity). It is concluded that negative results by the GeneXpert can not rule out the possibility of SARS-CoV-2 infection, particularly in close-contact individuals and the interpretation of the positive result should be analyzed carefully, particularly amplification with Ct>40.
GeneXpert与室内N1N2 CDC实时RT-PCR检测SARS-CoV-2感染的比较研究
COVID-19是一种由SARS-CoV-2引起的疾病,SARS-CoV-2是一种来自β冠状病毒属的新病毒。世卫组织于2020年3月11日宣布该病为大流行,迄今为止。核酸检测因其高灵敏度和特异性而成为最常用的检测方法。其中一项测试是GeneXpert,这是一种基于实时逆转录聚合酶链反应(rRT-PCR)的检测平台。基因专家的使用显示出极大的公共卫生兴趣,因为快速(50分钟)、训练有素的工作人员数量最少、基础设施和设备较少。然而,关于GeneXpert在检测SARS-CoV-2中的应用的数据有限。因此,我们对GeneXpert和内部N1N2 CDC rRT-PCR进行了比较研究。86份样本中,17份rRT-PCR阳性,13份GeneXpert阳性。在rRT-PCR阳性的17份样本中,GeneXpert阴性7份[58.82%(10/17)敏感性]。我们还发现3份GeneXpert阳性样本为rRT-PCR阴性(95.65%[66/69]特异性)。结论:GeneXpert阴性结果不能排除SARS-CoV-2感染的可能性,特别是在密切接触者中,应仔细分析阳性结果的解释,特别是Ct>40的扩增结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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