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.
基金
supported by the National Natural Science Foundation of China(No.31600666)。
