Serological immunochromatographic approach in diagnosis with SARS-CoV-2 infected COVID-19 patients
Serological immunochromatographic approach in diagnosis with SARS-CoV-2 infected COVID-19 patients
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DOI：
10.1016/j.jinf.2020.03.051
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发表时间：
2020-07-01
影响因子：
28.2
通讯作者：
Li, Yirong
中科院分区：
文献类型：
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作者：
Pan, Yunbao;Li, Xinran;Li, Yirong
新型冠状病毒 SARS-CoV-2 在中国武汉爆发，并迅速传播到其他城市和国家。临床广泛采用的标准诊断方法是实时RT-PCR核酸检测。然而，该技术的假阴性率是不可忽视的，并且迫切需要血清学方法。在这里，我们展示了针对病毒 IgM 或 IgG 抗体的胶体金免疫层析 (ICG) 试纸条，并将其与实时 RT-PCR 进行了比较。 IgM和IgG联合检测的ICG检测对核酸确诊病例的早期（发病后1-7天）、中期（发病后8-14天）和晚期（15天以上）敏感度分别为11.1%、92.9%和96.8%。 ICG对核酸阴性疑似病例的检出率为43.6%。此外，全血样本和血浆的一致性显示Cohen's kappa值为0.93，这代表两类样本之间几乎完美的一致性。总之，血清学ICG试纸条检测检测SARS-CoV-2感染既敏感又一致，被认为是临床应用的一个很好的补充方法。 (C) 2020 英国感染协会。由爱思唯尔有限公司出版。保留所有权利。
An outbreak of new coronavirus SARS-CoV-2 was occurred in Wuhan, China and rapidly spread to other cities and nations. The standard diagnostic approach that widely adopted in the clinic is nucleic acid detection by real-time RT-PCR. However, the false-negative rate of the technique is unneglectable and serological methods are urgently warranted. Here, we presented the colloidal gold-based immunochromatographic (ICG) strip targeting viral IgM or IgG antibody and compared it with real-time RT-PCR. The sensitivity of ICG assay with IgM and IgG combinatorial detection in nucleic acid confirmed cases were 11.1%, 92.9% and 96.8% at the early stage (1-7 days after onset), intermediate stage (8-14 days after onset), and late stage (more than 15 days), respectively. The ICG detection capacity in nucleic acid-negative suspected cases was 43.6%. In addition, the concordance of whole blood samples and plasma showed Cohen's kappa value of 0.93, which represented the almost perfect agreement between two types of samples. In conclusion, serological ICG strip assay in detecting SARS-CoV-2 infection is both sensitive and consistent, which is considered as an excellent supplementary approach in clinical application. (C) 2020 The British Infection Association. Published by Elsevier Ltd. All rights reserved.