时间分辨荧光免疫法检测TP-Ab在梅毒筛查试验中的应用价值  

The application value of TRIFMA for detection of syphilis antibody in the clinical screening tests

作　　者：何聚莲 谢慈嘉 杨皓云 龙彩云 梁秀珍 HE Ju-lian;XIE Ci-jia;YANG Hao-yun;LONG Cai-yun;LIANG xiu-zhen(Medical Laboratory,Third Affiliated Hospital of Guangzhou Traditional Chinese Medicine University,Guangzhou,Guangdong 510000)

机构地区：[1]广州中医药大学第三附属医院检验科

出　　处：《皮肤病与性病》2019年第5期644-647,共4页Dermatology and Venereology

摘　　要：目的对时间分辨荧光免疫法(TRIFMA)检测梅毒抗体(TP-Ab)试验数值进行分析,探讨适合梅毒的筛查方法和流程。方法收集2018年8 711例临床血清样本,采用TRIFMA检测梅毒特异性抗体,经TRIFMA检测TP-Ab的阳性血清样本280份,用TPPA对这280份标本进行复检,得到TRIFMA检测TP-Ab的敏感度、特异度;采用SPSS 19.0软件做统计学处理,绘制TP-Ab的TRIFMA检测数值受试者工作特性(ROC)曲线,用卡方检验验证TRIFMA法检测的数值有无性别年龄差异;将TRIFMA值从低到高依次分为13组,进一步探讨TRIFMA不同的值区间可信度以及最佳诊断临界点。结果TRIFMA检测TP-Ab的阳性率为3.21%,诊断准确度为99.54%;TRIFMA检测的假阳性无性别差异(P>0.05),但假阳性率随年龄的增高有升高的趋势;复检样本中S/CO为1≤X<5组阳性符合率为10.81%,S/CO为5≤X<10组阳性符合率为61.11%,S/CO为≥10组阳性符合率为100%。三组符合率差异有统计学意义(P<0.05)。TRIFMA的最佳检测能效区间为7.435~13.742;可信度最高的TRIFMA检测值约为7.651,此时敏感度为0.958,特异度为0.975,值均大于0.7。结论合理确定TRIFMA检测TP-Ab的最佳诊断界点和不同的值区间可信度,其灵敏度和特异度较高,误诊率较低,对梅毒筛查具有良好的诊断价值。Objective To evaluate the application value of Double-antigen Sandwich Time-resolved Immunofluorometric Assay(TRIFMA) for detection of syphilis antibody in the suitable screening tests and procedure. Methods 8 711 serum samples were collected and detected by TRIFMA for testing syphilitic specific antibody, 280 samples were positive and they would be subjected to TPPA for further confirmation. The sensibility and specificity of TRIFMA kit detecting TP-Ab was obtained when SPSS 19.0 software was used to draw the receiver operating charcteristics(ROC) curve of TP-Ab. The chi-square test was used to verify whether the values detected by the TRIFMA were gender or age difference;the samples are divided into 13 groups from low to high value to discuss the reliability of different results interval and the best diagnostic ponit of TP-Ab kit. Results The positive rate of TRIFMA was 3.21%, the diagnostic accuracy rates of the TRIFMA kit was 99.54%;There is no gender difference in false positives detected by TRIFMA(P > 0.05).The false positives of TRIFMA with the increasing of age have a higher trend at all age groups, the false positive rate above 65 years old was the highest(P < 0.05);Compared with TPPA method, the positive coincidence rate was 10.81% for patients whose S/CO were 1 ≤ x < 5,the positive coincidence rate was 61.11% for patients whose S/CO were 5 ≤ x < 10,the positive coincidence rate was 100% for patients whose S/CO were ≥ 10, there were statistical significance(P < 0.05);TRIFMA’s best detection energy efficiency range is 7.435 ~ 13.742;the most reliable TRIFMA detection value is about 7.651, the sensitivity is 0.958, the specificity is 0.975, and the value is greater than 0.7. Conclusion TRIFMA was suggested as a screening test for the diagnosis of syphilis, reasonable determination the best diagnostic boundary of TP-Ab by TRIFMA and different value interval confidence, its sensitivity and specificity is high, misdiagnosis rate is low, it has a good diagnostic value for syphilis screening.

关 键 词：梅毒抗体 时间分辨荧光免疫法 TPPA 

分 类 号：R446.62[医药卫生—诊断学] R759.1[医药卫生—临床医学]