机构：[1]Taizhou Hospital, Wenzhou Medical University, Linhai 317000, China台州医院[2]Institute of Digestive Diseases, School of Medicine, Tongji University, Tongji Hospital Affiliated to Tongji University, Shanghai 200065, China[3]Hongqiao International Institute of Medicine, Shanghai Tongren Hospital and Clinical Research Institute, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China[4]Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China华中科技大学同济医学院附属协和医院[5]National Engineering Center for Biochip at Shanghai, Shanghai 201203, China[6]China Center of Molecular Medicine for Helicobacter Pylori, Shanghai 201321, China[7]Shanghai Engineering Technology Center for Molecular Medicine, Shanghai 201023, China[8]State Key Laboratory of Genetic Engineering, School of Life Sciences, Fudan University, Shanghai 200433, China.
Background: Since December 2019, there had been an outbreak of COVID-19 in Wuhan, China. At present, diagnosis COVID-19 were based on real-time RT-PCR, which have to be performed in biosafe laboratory and is unsatisfactory for suspect case screening. Therefore, there is an urgent need for rapid diagnostic test for COVID-19. Objective: To evaluate the diagnostic performance and clinical utility of the colloidal gold immunochromatography assay for SARS-Cov-2 specific IgM/IgG anti-body detection in suspected COVID-19 cases. Methods: In the prospective cohort, 150 patients with fever or respiratory symptoms were enrolled in Taizhou Public Health Medical Center, Taizhou Hospital, Zhejiang province, China, between January 20 to February 2, 2020. All patients were tested by the colloidal gold immunochromatography assay for COVID-19. At least two samples of each patient were collected for RT-PCR assay analysis, and the PCR results were performed as the reference standard of diagnosis. Meanwhile 26 heathy blood donor were recruited. The sensitivity and specificity of the immunochromatography assay test were evaluated. Subgroup analysis were performed with respect to age, sex, period from symptom onset and clinical severity. Results: The immunochromatography assay test had 69 positive result in the 97 PCR-positive cases, achieving sensitivity 71.1% [95% CI 0.609-0.797], and had 2 positive result in the 53 PCR-negative cases, achieving specificity 96.2% [95% CI 0.859-0.993]. In 26 healthy donor blood samples, the immunochromatography assay had 0 positive result. In subgroup analysis, the sensitivity was significantly higher in patients with symptoms more than 14 days 95.2% [95% CI 0.741-0.998] and patients with severe clinical condition 86.0% [95% CI 0.640-0.970]. Conclusions: The colloidal gold immunochromatography assay for SARS-Cov-2 specific IgM/IgG anti-body had 71.1% sensitivity and 96.2% specificity in this population, showingthe potential for a useful rapid diagnosis test for COVID-19. Further investigations should be done to evaluate this assay in variety of clinical settings and populations.
基金：
National Natural Science Foundation of ChinaNational Natural Science Foundation of China [81672086, 81903417]; Department of Epidemiology and Health Statistics School of Public Health, Zhejiang University
第一作者机构：[1]Taizhou Hospital, Wenzhou Medical University, Linhai 317000, China
共同第一作者：
通讯作者：
通讯机构：[1]Taizhou Hospital, Wenzhou Medical University, Linhai 317000, China[2]Institute of Digestive Diseases, School of Medicine, Tongji University, Tongji Hospital Affiliated to Tongji University, Shanghai 200065, China[3]Hongqiao International Institute of Medicine, Shanghai Tongren Hospital and Clinical Research Institute, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China[5]National Engineering Center for Biochip at Shanghai, Shanghai 201203, China[*1]Ins-titute of Digestive Diseases, School of Medicine, Tongji University, Tongji Hospital Affiliated to Tong-ji University, Shanghai 200065, China[*2]Taizhou Hospital, Wenzhou Medical University, Linhai 317000, China[*3]Hongqiao International Institute of Medicine, Shanghai Tongren Hospital and Clinical Research Institute, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
推荐引用方式(GB/T 7714)：
Bo Shen,Yufen Zheng,Xiaoyan Zhang,et al.Clinical evaluation of a rapid colloidal gold immunochromatography assay for SARS-Cov-2 IgM/IgG[J].AMERICAN JOURNAL OF TRANSLATIONAL RESEARCH.2020,12(4):1348-1354.
APA：
Bo Shen,Yufen Zheng,Xiaoyan Zhang,Weituo Zhang,Donglian Wang...&Hengjun Gao.(2020).Clinical evaluation of a rapid colloidal gold immunochromatography assay for SARS-Cov-2 IgM/IgG.AMERICAN JOURNAL OF TRANSLATIONAL RESEARCH,12,(4)
MLA：
Bo Shen,et al."Clinical evaluation of a rapid colloidal gold immunochromatography assay for SARS-Cov-2 IgM/IgG".AMERICAN JOURNAL OF TRANSLATIONAL RESEARCH 12..4(2020):1348-1354
