详情页 - 聚合机构库演示平台

当前位置：首页 > 详情页

Clinical evaluation of a rapid colloidal gold immunochromatography assay for SARS-Cov-2 IgM/IgG

文献详情

资源类型：

作者：

单位： [a]Taizhou Hospital, Wenzhou Medical University, Linhai, 317000, China [b]Institute of Digestive Diseases, School of Medicine, Tongji University, Tongji Hospital Affiliated to Tongji University, Shanghai, 200065, China [c]Hongqiao International Institute of Medicine, Shanghai Tongren Hospital and Clinical Research Institute, Shanghai Jiao Tong University, School of Medicine, Shanghai, 200025, China [d]Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China [e]National Engineering Center for Biochip at Shanghai, Shanghai, 201203, China [f]China Center of Molecular Medicine for Helicobacter Pylori, Shanghai, 201321, China [g]Shanghai Engineering Technology Center for Molecular Medicine, Shanghai, 201023, China [h]State Key Laboratory of Genetic Engineering, School of Life Sciences, Fudan University, Shanghai, 200433, China

出处：

ISSN：

关键词： COVID-19 Immunoglobulin M/immunoglobulin G Rapid diagnosis

摘要：

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, showing the 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. © 2020 E-Century Publishing Corporation. All rights reserved.

基金：

语种：

中科院(CAS)分区：

出版当年[2019]版：

大类 | 3 区医学

小类 | 3 区医学：研究与实验 4 区肿瘤学

最新[2025]版：

大类 | 4 区医学

小类 | 4 区医学：研究与实验 4 区肿瘤学

第一作者：

第一作者单位： [a]Taizhou Hospital, Wenzhou Medical University, Linhai, 317000, China

通讯作者：

通讯机构： [b]Institute of Digestive Diseases, School of Medicine, Tongji University, Tongji Hospital Affiliated to Tongji University, Shanghai, 200065, China [e]National Engineering Center for Biochip at Shanghai, Shanghai, 201203, China

推荐引用方式(GB/T 7714)：

APA：

MLA：

Clinical evaluation of a rapid colloidal gold immunochromatography assay for SARS-Cov-2 IgM/IgG

文献详情

相关文献