自制肺炎衣原体抗原的临床应用

Clinical Application of Self-Made Chlamydia Pneumoniae-Antigen

目的:评估自制肺炎衣原体抗原(Chlamydia pneumoniae-antigen,Cpn-Ag)用于肺炎衣原体(Chlamydia pneumoniae,Cpn)感染的诊断价值。方法:采用Dot-ELISA法观察自制Cpn-Ag与进口Cpn-单克隆抗体(McAb)的结合反应。采用微量免疫荧光法,用自制Cpn-Ag和进口Cpn-Ag同时检测268例血浆标本的Cpn-IgA、IgG和IgM。结果:Dot-ELISA结果显示,自制Cpn-Ag可与McAb发生特异性结合反应。自制Cpn-Ag与进口Cpn-Ag检测血浆中Cpn-IgA、IgG、IgM抗体滴度的一致率均达90%以上;以进口Cpn-Ag检测为标准,自制Cpn-Ag检测灵敏度、特异度均在90%以上;阳性似然比均>10,阴性似然比均<0.1。配对卡方检验显示,自制Cpn-Ag与进口Cpn-Ag检测血浆Cpn-IgA、IgG、IgM的结果比较,差异无统计学意义(P>0.05);一致性检验显示,Kappa值>0.75,两者具有高度一致性。结论:采用自制Cpn-Ag检测血浆Cpn-IgA、IgG、IgM,具有较高的灵敏度和特异度,与采用进口Cpn-Ag的检测结果具有高度一致性。

Objective：To evaluate the diagnostic value of self-made chlamydia pneumoniae-antigen（Cpn-Ag）.Methods：The binding reaction between the self-made Cpn-Ag and Cpn-antibody（Cpn-McAb） from USA was observed using Dot-ELISA method.Then the Cpn-IgA,IgG and IgM in plasma of 268 patients were detected by micro-immunofluorescence（MIF） with self-made Cpn-Ag and Cpn-Ag from USA at the same time.Results： The result of Dot-ELISA showed specific binding reaction between the self-made Cpn-Ag and Cpn-McAb.The accordance among the results of self-made Cpn-Ag and Cpn-Ag from USA was excellent for the IgM、IgG and IgA detection rates（90%）.The self-made Cpn-Ag had good sensitivity and specificity（90%）.Likelihood ratios（LRs） for the positive test results were greater than 10 and LRs were less than 0.1 for the negative test results.McNemar ＇s test showed that the two kinds of antigen had no difference in detecting Cpn-IgA,IgG and IgM（P0.05）,and a high accordance between them was showed by Kappa（0.75）.Conclusions： The self-made Cpn-Ag has great specificity and sensitivity in the detection of Cpn-Ab,and it also has high accordance with Cpn-Ag from USA.