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Clinical Performance of SARS-CoV-2 IgG and IgM Tests Using an Automated Chemiluminescent Assay

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收录情况: ◇ SCIE ◇ 卓越:梯队期刊

单位: [1]Huazhong Univ Sci & Technol, Tongji Med Coll, Tongji Hosp, Dept Blood Transfus, Wuhan 430030, Peoples R China [2]Huazhong Univ Sci & Technol, Tongji Med Coll, Tongji Hosp, Dept Lab Med, Wuhan 430030, Peoples R China
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关键词: COVID-19 SARS-CoV-2 IgG IgM chemiluminescence

摘要:
Serology tests for viral antibodies provide an important tool to support nucleic acid testing for diagnosis of the novel coronavirus disease 2019 (COVID-19) and is useful for documenting previous exposures to SARS-CoV-2, the etiological agent of COVID-19. The sensitivities of the chemiluminescent SARS-CoV-2 IgG/IgM immunoassay were assessed by using serum samples collected from 728 patients testing positive for SARS-CoV-2 RNA. The specificity was evaluated on a panel of 60 serum samples from non-COVID-19 patients with high levels of rheumatoid factor, antinuclear antibody, or antibodies against Epstein-Barr virus (EBV), cytomegalovirus (CMV), mycoplasma pneumonia, human respiratory syncytial virus (RSV), adenovirus, influenza A or influenza B. The imprecision and interference were assessed by adopting the Clinical and Laboratory Standards Institute (CLSI) EP15-A2 and EP7-A2, respectively. Sensitivities between 1 and 65 days after onset of symptoms were 94.4% and 78.7%, for IgG and IgM test, respectively. The sensitivity increased with the time after symptom onset, and rose to the top on the 22nd to 28th days. The total imprecision (CVs) was less than 6.0% for IgG and less than 6.5% for IgM. Limited cross-reactions with antibodies against EBV, CMV, mycoplasma pneumonia, human RSV, adenovirus, influenza A or influenza B were found. These data suggested the chemiluminescent SARS-CoV-2 IgG and IgM, assay with reliable utility and sensitivity, could be used for rapid screening and retrospective surveillance of COVID-19.

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出版当年[2020]版:
大类 | 4 区 医学
小类 | 4 区 医学:研究与实验
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 医学:研究与实验
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出版当年[2019]版:
Q4 MEDICINE, RESEARCH & EXPERIMENTAL
最新[2023]版:
Q3 MEDICINE, RESEARCH & EXPERIMENTAL

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第一作者单位: [1]Huazhong Univ Sci & Technol, Tongji Med Coll, Tongji Hosp, Dept Blood Transfus, Wuhan 430030, Peoples R China
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