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目的对CMIA与梅毒检测常用的其他3种方法在临床上的应用进行分析与评价。方法应用CMIA(磁微粒化学发光法)、ELISA(酶联免疫吸附试验)、RPR(快速血浆反应素试验)和TPPA(梅毒螺旋体明胶颗粒凝集试验)检测血清标本中的梅毒螺旋体抗体,对这几种方法的灵敏度和特异性进行分析;此外对CMIA与TPPA检测结果符合率及血清转化盘结果进行研究。结果以TPPA为金标准,CMIA的灵敏度和特异性分别为100%和99.87%,高于ELISA及RPR;CMIA与TPPA的阳性、阴性及总体符合率为100%、99.88%和99.88%。结论CMIA重复性好,灵敏度及特异性比较高,且操作简便快捷,可以取代TPPA及ELISA用于梅毒螺旋体的诊断。
Objective To analyze and evaluate the clinical application of CMIA and other three commonly used methods of syphilis testing. Methods CMIA (magnetic particle chemiluminescence), ELISA (enzyme-linked immunosorbent assay), RPR (rapid plasma reactive element assay) and TPPA (syphilitic spirochete gelatin particle agglutination test) were used to detect the serum of Treponema pallidum antibody. Sensitivity and specificity of the method were analyzed. In addition, the coincidence rate of CMIA and TPPA test results and the result of seroconversion were also studied. Results With TPPA as the gold standard, the sensitivity and specificity of CMIA were 100% and 99.87%, respectively, higher than that of ELISA and RPR. The positive, negative and overall coincidence rates of CMIA and TPPA were 100%, 99.88% and 99.88% respectively. Conclusions CMIA has good repeatability, high sensitivity and specificity, and is simple and quick to operate. It can replace TPPA and ELISA for the diagnosis of Treponema pallidum.