使用化学发光法检测26707例血清抗梅毒螺旋体特异性抗体以及结果假阳性率分析

Analyze of the False Positive Rate of Serum Anti Treponema Pallidum Specific Antibody of 26 707 Cases Detected by Chemiluminescence Method

目的：用雅培 I2000SR 全自动化学发光微粒子免疫分析仪检测26707例血清抗梅毒螺旋体特异性抗体，以梅毒螺旋体抗体明胶颗粒凝集试验法（TPPA）作为检查抗梅毒螺旋体特异度抗体标准参考方法，分析判定雅培 I2000SR 全自动化学发光微粒子免疫分析仪检测的假阳性率。方法收集内蒙古医科大学附属医院2013年9月1日～2014年3月5日的住院和门诊患者26707人份血清，要求受检者空腹条件下采取静脉血3 ml，3000 r／min 离心10 min 后分离血清，上机检测。使用化学发光微粒子免疫分析（CMIA）、明胶颗粒凝集试验法（TPPA）对血清梅毒螺旋体特异性抗体（Anti-TP）进行检测。运用统计学方法对检测结果进行分析。结果雅培 I2000SR 全自动化学发光微粒子免疫分析仪检测的26707例血清梅毒螺旋体特异性抗体 S／CO 值在1～的标本数52例，经 TPPA 验证阳性数9例，阳性率17.31％；S／CO 值在2～的标本数26例，阳性数9例，阳性率34.62％；S／CO 值在3～的标本数26例，阳性数9例，阳性率34.62％；S／CO 值在5～的标本数25例，阳性数11例，阳性率44％；S／CO 值在7～的标本数25例，阳性数17例，阳性率68％；S／CO 值在10～的标本数28例，阳性数24例，阳性率85.71％；S／CO 值在13～的标本数23例，阳性数20例，阳性率86.96％；S／CO 值在17～的标本数24例，阳性数22例，阳性率91.67％；S／CO 值在21～的标本数29例，阳性数28例，阳性率96.55％；S／CO 值在26的标本数104例，阳性数104例，阳性率100％；总初筛阳性例数364例，总真阳性例数254例，阳性率69.78％；假阳性率0.42％，阳性预测值69.78％。结论雅培 I2000SR 全自动化学发光微粒子免疫分析仪采用自动化检测、全封闭试剂，具有操作简单、检测速度快、结果更准确等特点。虽然其灵敏度高，但存在一定的假阳性，不可以仅凭其结果进行诊断，还需要 TPPA 方法进行补充检测确证。

Objective To detect serum anti-Treponema pallidum specific antibody of 26 707 cases by Abbott I2000SR auto-matic chemiluminescent microparticle immunoassay analyzer,and treponema pallidum particle agglutination assay （TPPA） was regarded as a standard reference method which was used to detect anti-Treponema pallidum specific antibody.To analyze the false positive rate of Abbott I2000SR according to the TPPA.Methods Collected 26 707 serums from inpatients and outpatients of the hospital during September 1,2013 to March 5,2014.The subjects were asked to fasting conditions taking venous blood 3 ml,3 000 r/min centrifugal 10 min utes after the separation of serum,detected the Anti-TP by CMIA （Ab-bott I2000SR）and the TPPA testing,analyzed test results by statistical methods.Results There were 52 cases detected by I2000SR whose S/CO values of 26 707 cases of serum Treponema pallidum specific antibodies were 1 to 2,of which 9 cases were verified positive by TPPA,and the positive rate was 17.31%.There were 26 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were 2 to 3,of which 9 cases were verified positive by TPPA,and the positive rate was 34.62%.There were 26 cases detected by I2000SR whose S/CO values of Treponema pallidum specific anti-bodies were 3 to 5,of which 9 cases were verified positive by TPPA,and the positive rate was 34.62%.There were 25 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were 5 to 7,of which 11 cases were verified positive by TPPA,and the positive rate was 44%.There were 25 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were 7 to 10,of which 17 cases were verified positive by TPPA,and the positive rate was 68%.There were 28 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were 10to 13,of which 24 cases were verified positive by TPPA,and the positive rate was 85.71%.There were 23 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were 13 to 17,of which 20 cases were verified positive by TPPA,and the positive rate was 86.96%.There were 24 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were 17 to 21,of which 22 cases were verified positive by TPPA,and the positive rate was 91.67%.There were 29 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were 21 to 26,of which 28 cases were verified positive by TPPA,and the positive rate was 96.55%.There were 104 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were above 26,of which 104 cases were verified positive by TPPA,and the positive rate was 100%.The total number of positive cases were 364,of which 254 were positive ca-ses,the positive rate was 69.78%.False positive rate was 0.42% and positive predictive value was 69.78%.Conclusion Abbott I2000SR automated chemiluminescent microparticle immunoassay analyzer has the feature of automated detection, closed reagents,simple operation,speed,and more accurate results and so on.Although high sensitivity but its results have false positive,so cannot diagnose based on the results of Abbott I2000SR,and need use of the TPPA to test and corroborate.