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Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis.

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机构: [1]State Key Laboratory of Respiratory Disease,National Clinical Research Center forRespiratory Disease, Guangzhou Institute ofRespiratory Health, The First AffiliatedHospital of Guangzhou Medical University,Guangzhou, China [2]The 2nd Hospital of Nanjing, NanjingUniversity of Chinese Medicine, Nanjing, China [3]Chongqing Public Health Medical Center,Chongqing, China [4]Union Hospital, Tongji Medical College,Huazhong University of Science andTechnology, Wuhan, China [5]The 1st Affiliated Hospital of NanchangUniversity, Nanchang, China [6]Department of Pulmonary and Critical CareMedicine, Guangdong Second ProvincialGeneral Hospital, Guangzhou, Guangdong,China [7]Wuhan No. 1 Hospital, Wuhan, China [8]The 1st Affiliated Hospital of Xi'an JiaotongUniversity, Xi'an, China [9]Jiangsu Medomics Medical Technology Co.,Ltd, Nanjing, China [10]Hunan Provincial Center for Disease Controland Prevention, Changsha, China
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关键词: COVID‐19 fingerstick blood lateral flow immunoassay point‐of‐care testing rapid IgM‐IgG combined test SARS‐CoV‐2 virus infection

摘要:
The outbreak of the novel coronavirus disease (COVID-19) quickly spread all over China and to more than 20 other countries. Although the virus (severe acute respiratory syndrome coronavirus [SARS-Cov-2]) nucleic acid real-time polymerase chain reaction (PCR) test has become the standard method for diagnosis of SARS-CoV-2 infection, these real-time PCR test kits have many limitations. In addition, high false-negative rates were reported. There is an urgent need for an accurate and rapid test method to quickly identify a large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients. We have developed a rapid and simple point-of-care lateral flow immunoassay that can detect immunoglobulin M (IgM) and IgG antibodies simultaneously against SARS-CoV-2 virus in human blood within 15 minutes which can detect patients at different infection stages. With this test kit, we carried out clinical studies to validate its clinical efficacy uses. The clinical detection sensitivity and specificity of this test were measured using blood samples collected from 397 PCR confirmed COVID-19 patients and 128 negative patients at eight different clinical sites. The overall testing sensitivity was 88.66% and specificity was 90.63%. In addition, we evaluated clinical diagnosis results obtained from different types of venous and fingerstick blood samples. The results indicated great detection consistency among samples from fingerstick blood, serum and plasma of venous blood. The IgM-IgG combined assay has better utility and sensitivity compared with a single IgM or IgG test. It can be used for the rapid screening of SARS-CoV-2 carriers, symptomatic or asymptomatic, in hospitals, clinics, and test laboratories.

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出版当年[2019]版:
大类 | 4 区 医学
小类 | 4 区 病毒学
最新[2025]版:
大类 | 3 区 医学
小类 | 3 区 病毒学
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出版当年[2018]版:
Q3 VIROLOGY
最新[2024]版:
Q1 VIROLOGY

影响因子: 最新[2024版] 最新五年平均 出版当年[2018版] 出版当年五年平均 出版前一年[2017版] 出版后一年[2019版]

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第一作者机构: [1]State Key Laboratory of Respiratory Disease,National Clinical Research Center forRespiratory Disease, Guangzhou Institute ofRespiratory Health, The First AffiliatedHospital of Guangzhou Medical University,Guangzhou, China
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通讯机构: [*1]State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 510120 Guangzhou, China
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