化学发光微粒子免疫法在梅毒特异性抗体检测中的应用

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[目的]对化学发光微粒子免疫(chemiluminescence microparticle immuno assay,CMIA)法在梅毒特异性抗体检测中的应用价值进行分析,为今后的临床工作提供有价值的参考信息。[方法]选择2015年1月—2016年12月间收集到的需要进行梅毒筛查试验的3 445份标本作为研究对象,对其分别采用CMIA法和梅毒甲苯胺红不加热血清试验(tolulized red unheated serum test,TRUST)法展开梅毒特异性抗体检测,并采用苍白密螺旋体明胶颗粒凝集试验(treponema pallidum particle assay,TPPA)对检测结果进行确认,对检测结果进行统计学分析。[结果]CMIA法测得阳性标本157份,阳性率4.56%;TRUST法测得阳性标本114份,阳性率为3.31%;前者阳性率高于后者,差异有统计学意义(P<0.05)。CMIA法检测敏感性为99.36%,特异性为99.97%,假阳性率为0.03%,假阴性率为0.64%,正确指数为99.33%,诊断符合率为99.94%;TRUST法检测敏感性为67.52%,特异性为98.47%,假阳性率为0.24%,假阴性率为32.48%,正确指数为65.99%,诊断符合率为98.29%。前者检测敏感性、正确指数和诊断符合率高于后者,且假阳性率、假阴性率低于后者,差异均有统计学意义(P<0.01)。[结论]在梅毒特异性抗体筛查中,CMIA法的准确性、敏感性均相对较高,临床价值显著,值得关注并推广。 [Objective] To analyze the value of chemiluminescence microparticle immunoassay (CMIA) in the detection of syphilis-specific antibodies and provide valuable reference information for future clinical work. [Methods] A total of 3 445 specimens collected from January 2015 to December 2016 for syphilis screening were selected as research subjects. The patients were randomly divided into two groups: the CMIA method and the tolulized red unheated serum test (TRUST) method was used to detect syphilis-specific antibodies. The detection results were confirmed by treponema pallidum particle assay (TPPA), and the results were statistically analyzed. [Results] 157 samples were positive by CMIA, the positive rate was 4.56%. 114 positive samples were detected by TRUST, the positive rate was 3.31%. The positive rate of the former was higher than the latter (P <0.05) . The detection sensitivity of CMIA was 99.36%, the specificity was 99.97%, the false positive rate was 0.03%, the false negative rate was 0.64%, the correct index was 99.33% and the diagnostic coincidence rate was 99.94%. The sensitivity of TRUST assay was 67.52% , The specificity was 98.47%, the false positive rate was 0.24%, the false negative rate was 32.48%, the correct index was 65.99%, and the diagnostic coincidence rate was 98.29%. The former detection sensitivity, correct index and diagnostic coincidence rate higher than the latter, and false positive rate, false negative rate lower than the latter, the difference was statistically significant (P <0.01). [Conclusion] In the screening of syphilis specific antibodies, the accuracy and sensitivity of CMIA method are relatively high, the clinical value is significant, worthy of attention and promotion.
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