发光微粒子免疫分析法对梅毒检测应用评价

Evaluation of CMIA for Syphilitic Detection and Clinical Application

目的评价化学发光微粒子免疫分析法(chemiluminescent microparticlei mmunoassay,CMIA)对梅毒检测的临床应用价值。方法同时使用CMIA法与TPPA法检测梅毒的279例病人血清,分析二方法测定的阳性率,并以TPPA法为标准,评价CMIA法的敏感性、特异性、阳性预测值及阴性预测值;同时评价两方法的符合率。结果 CMIA法阳性率为81.72%,TPPA法阳性率为79.21%,两种方法的阳性检出率差异有统计学意义(χ2=5.14,P<0.05);CMIA法敏感性100%,特异性87.93%,阳性预测值96.93%,阴性预测值100%;CMIA法与TPPA法检测梅毒螺旋体抗体的符合率为97.49%。结论 CMIA法适用于梅毒初筛试验,可为临床提供重要的梅毒血清学诊断依据。

Objective To evaluate the clinical value of chemiluminescent microparticle immunoassay（CMIA） for detecting syphilis.Methods Totally 279 serum samples of patients with syphilis were detected by TPPA and CMIA simultaneously,and the positive rates detected by the two methods were analyzed.TPPA was served as the standard,the sensitivity,specificity,positive predictive value and negative predictive value of CMIA were evaluated.And the coincidence rate between TPPA and CMIA was assessed simultaneously.Results The positive rates of CMIA and TPPA were 81.72% and 79.21%,respectively;and there were statistically significant difference in the positive detection rates between the two methods（χ2=5.14,P0.05）.The sensitivity,specificity,positive predictive value and negative predictive value of CMIA were 100%,87.93%,96.93%,and 100%,respectively.The coincidence rate between TPPA and CMIA was 97.49%.Conclusions CMIA can be used as the screening test,which can provide the clinical diagnostic evidence.