摘要
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。
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.
作者
邓杰伦
王远芳
王婷婷
黄学东
吴思颖
王旻晋
李冬冬
陶传敏
谢轶
应斌武
DENG Jielun;WANG Yuanfang;WANG Tingting;HUANG Xuedong;WU Siying;WANG Minjin;LI Dongdong;TAO Chuanmin;XIE Yi;YING Binwu(Department of Laboratory Medicine,West China Hospital,Sichuan University,Chengdu,Sichuan 610041,China)
出处
《国际检验医学杂志》
CAS
2020年第8期964-966,970,共4页
International Journal of Laboratory Medicine
基金
四川大学华西医院新型冠状病毒肺炎疫情科技攻关项目(HX-2019-nCov-050)。
关键词
新型冠状病毒
新型冠状病毒肺炎
胶体金免疫层析法
免疫球蛋白M
总抗体
severe acute respiratory syndrome coronavirus 2
corona virus disease 2019
colloidal gold immunochromatographic assay
immunoglobulin M
total antibodies
