梅毒血清学检测策略和验证方法在临床梅毒诊断中的应用评价  

Evaluation of serological detection strategies and validation methods in clinical diagnosis of syphilis

作　　者：胡丽华[1] 黄佳[1] 杨波 潘露[1] HU Lihua;HUANG Jia;YANG Bo;PAN Lu(Department of Clinical Laboratory,Zhejiang Provincial Institute of Dermatology,Huzhou,Zhejiang 313200,China)

机构地区：[1]浙江省皮肤病防治研究所检验科,浙江湖州313200

出　　处：《国际检验医学杂志》2021年第10期1180-1183,1188,共5页International Journal of Laboratory Medicine

基　　金：浙江省医药卫生科技项目(2017KY314)。

摘　　要：目的通过对传统策略、逆向策略、双检策略这3种梅毒血清学检测策略和验证方法进行评估,探讨适用的梅毒血清学检测策略。方法选择该院确诊的251例梅毒螺旋体感染患者为研究组;同期100例在该院就诊并接受手术者为对照组,术前感染4项筛查(乙型肝炎、丙型肝炎、艾滋病、梅毒)阴性。特异性抗体分别采用化学发光免疫分析法(CLIA)、胶体金免疫层析法(ICT)检测,非特异性抗体采用甲苯胺红不加热血清反应素试验(TRUST)检测,评价传统策略、逆向策略、双检策略的性能。用TPPA、FTA-ABS和WB进行验证,比较各种策略间检测性能差异。结果采用CLIA进行特异性抗体检测的传统策略、逆向策略和双检策略的灵敏度分别为99.60%、100.00%、100.00%,准确度分别为99.72%、100.00%、100.00%,差异无统计学意义(χ^(2)=2.003,P=0.367;χ^(2)=2.002,P=0.368)。采用ICT进行特异性抗体检测的传统策略、逆向策略和双检策略的灵敏度分别为97.61%、98.01%、100.00%,准确度分别为98.29%、98.58%、100.00%,差异无统计学意义(χ^(2)=5.720,P=0.057;χ^(2)=5.696,P=0.058)。CLIA和ICT进行特异性抗体检测的3种策略的特异度均为100.00%。TPPA与WB比较,Kappa值为0.959,TPPA与FTA-ABS比较,Kappa值为0.854。结论双检策略及CLIA初筛的逆向策略性能较好,CLIA初筛的逆向策略适用于大型实验室,小型实验室可采用ICT+TRUST的双检策略,TPPA是首选的验证方法,WB可用于进一步确认。Objective To evaluate three serological detection strategies including traditional strategy,reverse strategy and double detection strategy and validation methods of syphilis,and to explore the suitable strategy for detecting syphilis.Methods A total of 251 patients with treponema pallidum infection were selected as the study group.During the same period,100 patients who received surgery were recruited in control group,and the four screening tests(hepatitis B,hepatitis C,AIDS,syphilis)for infection were negative before operation.The treponemal test were detected by chemiluminescence immunoassay(CLIA)and colloidal gold immunochromatography(ICT)respectively.The nontreponemal test was detected by toluidine red unheated serum reactivity assay(TRUST).The performance of three strategies were evaluated.TPPA,FTA-ABS and WB were used for verification,and the differences of detection performance among various strategies were compared.Results The sensitivity and accuracy of conventional,reverse and double detection strategies using CLIA for specific antibody detection were 99.60%,100.00%,100.00%,and 99.72%,100.00%,100.00%respectively,with no statistical significance(χ^(2)=2.003,P=0.367;χ^(2)=2.002,P=0.368).The sensitivity of the three strategies using ICT method was 97.61%,98.01%,100.00%,and the accuracy was 98.29%,98.58%,100.00%respectively(χ^(2)=5.720,P=0.057;χ^(2)=5.696,P=0.058).The specificity of three strategies using CLIA and ICT for specific antibody detection was 100.00%.The Kappa value was 0.959 between TPPA and WB,which was 0.854 between TPPA and FTA-ABS.Conclusion The double detection strategy and the reverse strategy using CLIA for preliminary screening have better performance.The reverse strategy using CLIA for preliminary screening is suitable for large laboratories,while the double detection strategy of ICT+TRUST could be used for small laboratories.TPPA is the preferred verification method,and WB could be used for further confirmation.

关 键 词：梅毒 血清学 检测策略 验证方法 

分 类 号：R759.1[医药卫生—皮肤病学与性病学]