Liu Caixia, Mao Baiping, Martinez Vanessa, Chen Xiaojian, Li Yanan, He Lingyun, Chen Sian, Guo Xiaoling, Shen Xian, Bao Xiandan, Shen Haifa, Lenna Stefania, Qian Pinyi, Wu Lingzhi, Li Chao
The Second Affiliated Hospital, Yuying Children's Hospital of Wenzhou Medical University 109 Xueyuan West Road Wenzhou 325027 PR China
Houston Methodist Research Institute, University of St. Thomas 3800 Montrose Blvd Houston TX 77006 USA.
RSC Adv. 2020 Jul 28;10(47):28041-28048. doi: 10.1039/d0ra04107f. eCollection 2020 Jul 27.
The outbreak of new coronavirus disease (COVID-19) has quickly spread all over the world. Real time reverse transcriptase polymerase chain reaction (rRT-PCR) for nucleic acid detection has become the standard method for clinical diagnosis of COVID-19 infection. But these rRT-PCR tests have many inherent limitations, and carry a high false negative rate. It is an urgent to develop a method to accurately identify the vast infected patients and asymptomatic viral carriers from the population. In this article, we present the principle and procedure of developing a colloidal gold immunochromatographic assay (GICA) for rapid detection of COVID-19-specific antibodies. The detection kit can be used to detect immunoglobulin M (IgM) and IgG of COVID-19 in human blood samples within 15 minutes, and to identify different stages of viral infection. Test results can be digitalized using an office scanner and a FiJi software with appropriate confidence interval (CI) setting. Based on analysis from 375 samples, we calculated that overall sensitivity and specificity of the assay were 95.85% and 97.47%, respectively. Compared with rRT-PCR, this assay has many advantages including convenience and rapid detection. The detection kit can be widely used in hospitals, clinics and laboratories for rapid screening of both symptomatic and asymptomatic COVID-19 carriers in large scale.
新型冠状病毒病（COVID-19）疫情已迅速蔓延至全球。用于核酸检测的实时逆转录聚合酶链反应（rRT-PCR）已成为COVID-19感染临床诊断的标准方法。但这些rRT-PCR检测存在许多固有局限性，且假阴性率很高。迫切需要开发一种方法，以便从人群中准确识别大量受感染患者和无症状病毒携带者。在本文中，我们介绍了开发用于快速检测COVID-19特异性抗体的胶体金免疫层析法（GICA）的原理和步骤。该检测试剂盒可在15分钟内用于检测人血样本中COVID-19的免疫球蛋白M（IgM）和IgG，并识别病毒感染的不同阶段。检测结果可使用办公扫描仪和具有适当置信区间（CI）设置的FiJi软件进行数字化处理。基于对375份样本的分析，我们计算出该检测方法的总体灵敏度和特异性分别为95.85%和97.47%。与rRT-PCR相比，该检测方法具有许多优点，包括方便和检测快速。该检测试剂盒可广泛应用于医院、诊所和实验室，用于大规模快速筛查有症状和无症状的COVID-19携带者。
