双抗原夹心免疫层析法在新型冠状病毒感染诊断中的应用

目的:探讨双抗原夹心免疫层析法抗体检测在新型冠状病毒(2019-nCoV)感染中的诊断价值。方法:选取在医院就诊的179例新型冠状病毒肺炎(COVID-19)患者为临床诊断阳性病例,另选同期就诊的85例确诊未感染2019-nCoV患者为临床诊断阴性病例。采用基于双抗原夹心法的胶体金免疫层析法和上转发光免疫层析法进行血清总抗体(IgG、IgM和IgA)检测,分析两种方法2019-nCoV总抗体(IgG、IgM和IgA)检测结果与临床诊断的灵敏度、特异度和总符合率。结果:建立针对2019-nCoV抗体检测的双抗原夹心免疫层析方法,胶体金免疫层析法检测血清2019-nCoV总抗体(IgG、IgM和IgA)与临床诊断的灵敏度、特异度和总符合率分别为97.77%、100%和98.48%;上转发光免疫层析法分别为98.88%、100%和99.24%。两种检测方法检测血清2019-nCoV总抗体(IgG、IgM和IgA)的总符合率与临床诊断结果比较,差异有统计学意义(χ²=246.5,χ²=225.0;P<0.05)。结论:双抗原夹心法对于2019-nCoV抗体检测具有重要应用价值。

Application of double antigen sandwich immunochromatography assay in the diagnosis of 2019-nCoV infection

Objective:To explore the diagnostic value of antibodies detection by double antigen sandwich immunochromatography assay in detecting novel coronavirus(2019-nCoV)infection.Methods:179 patients with Coronavirus Disease 2019(COVID-19)who admitted to hospital were selected as positive cases of clinical diagnosis,and 85 patients without 2019-nCoV who admitted to hospital at the same term were selected as negative cases of clinical diagnosis.The colloidal gold immunochromatography on the basis of double antigen sandwich method and the up-converting phosphor immunochromatographic method were adopted to test the serum total antibodies(IgG,IgM and IgA).And then,the clinically diagnostic sensitivity,specificity and total coincidence rate of the detection results of two methods for total antibodies(IgG,IgM and IgA)of 2019-nCoV and the clinical diagnosis for COVID-19 were analyzed,respectively.Results:In this study,a novel double antigen sandwich immunochromatography for 2019-nCoV antibody was established.And the sensitivity,specificity and total consistence rate between colloidal gold immunochromatography and clinical diagnosis were 97.77%,100%and 98.48%respectively in detecting serum total antibodies(IgG,IgM and IgA)of 2019-nCoV.And those of up-converting phosphor immunochromatographic method were 98.88%,100%and 99.24%respectively.The differences of total consistence rates in detecting serum total antibodies(IgG,IgM and IgA)of 2019-nCoV between each detection method and clinical diagnosis were significant(χ²=246.5,χ²=225.0,P<0.05),respectively.Conclusion:The double antigen sandwich method has important application value in detecting serum total antibody of 2019-nCoV.