胶体金免疫层析法检测SARS-CoV-2血清抗体的临床价值探讨

目的通过对新型冠状病毒(SARS-CoV-2)免疫球蛋白(Ig)M和总抗体(即IgM/IgG)的检测,探讨应用胶体金免疫层析法(GICA法)在新型冠状病毒肺炎(COVID-19)诊断中的应用价值。方法收集76例患者共计83份血清,其中32例为SARS-CoV-2核酸阳性患者(确诊组),44例为SARS-CoV-2核酸阴性患者(对照组)。确诊组中7例患者为两次时间点采集标本。采用GICA法检测SARS-CoV-2 IgM和总抗体。结果GICA法检测SARS-CoV-2 IgM的灵敏度50.00%(16/32),特异度90.91%(40/44),符合率73.68%(56/76),阳性预测值80.00%(16/20)、阴性预测值71.43%(40/56);SARS-CoV-2总抗体检测的灵敏度68.75%(22/32)、特异度97.73%(43/44)、符合率85.53%(65/76)、阳性预测值95.65%(22/23)、阴性预测值81.13%(43/53)。GICA法检测SARS-CoV-2 IgM和总抗体的特异度均大于90%,符合率均大于70%,满足临床需求。结论GICA法检测SARS-CoV-2 IgM和总抗体,标本采集易标准化,报告时间快,灵敏度不高,但特异度较高,有辅助诊断的价值。

The clinical value of GICA in the detection of serum antibodies to SARS-CoV-2

Objective To investigate the diagnostic value of colloidal gold immunochromatographic assay(GICA)in corona virus disease 2019(COVID-19)through testing severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)immunoglobulin M(IgM)and total antibodies(IgM/IgG).Methods A total of 83 serum samples were collected from 76 patients,including 32 cases confirmed with nucleic acid test as confirmed group and 44 subjects who negative to SARS-CoV-2 infection as control group.The samples of 7 patients in confirmed group were collected at 2 time points.Serum IgM and total antibodies were measured with GICA.Results The sensitivity and specificity of serum IgM were 50.00%(16/32),90.91%(40/44)respectively.The coincidence rate,the positive and negative predictive values of IgM were 73.68%(56/76),80.00%(16/20),71.43%(40/56).The sensitivity and specificity of total antibodies were 68.75%(22/32),97.73%(43/44)respectively.The coincidence rate,the positive and negative predictive values of total antibodies were 85.53%(65/76),95.65%(22/23),81.13%(43/53).The specificity of SARS-CoV-2 IgM and total antibodies by GICA were above 90%,and the coincidence rates were above 70%,which suit for clinical needs.Conclusion GICA assay detects SARS-CoV-2 IgM and total antibodies which sample collection are easy to be standardized,reporting time is short,the sensitivity is not high,but the specificity is high,has the value of supplement diagnosis.