双抗原夹心时间分辨荧光免疫法检测梅毒螺旋体特异性总抗体的性能研究  

Evaluation of Double Antigen Sandwich Time-resolved Fluoroimmunoassay for Specific Total Antibodies to Treponema Pallidum

作　　者：谭玉华 雷泽洪 郑丹[3] 刘灿 赵凡一 TAN Yu-hua;LEI Ze-hong;ZHENG Dan;LIU Can;ZHAO Fan-yi(Reagent Research and Development Center of IVD Reagents ,Guangzhou Fenghua Bioengineering Co. Ltd. , Guangzhou 510730, China;Department of Clinical Laboratory, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Sun Yat-sen University ,Guangdong Jiangmen 529000, China;Department of Clinical Laboratory, the Eastern Hospital of the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510700, China)

机构地区：[1]广州市丰华生物工程有限公司体外诊断试剂研发中心,广州510730 [2]江门市中心医院检验科,中山大学附属江门医院,广东江门529000 [3]中山大学附属第一医院东院检验科,广州510700

出　　处：《现代检验医学杂志》2018年第2期97-100,共4页Journal of Modern Laboratory Medicine

摘　　要：目的对双抗原夹心时间分辨荧光免疫法(TRFIA)检测梅毒螺旋体(TP)特异性总抗体的性能进行研究。方法采用重组TP优势多表位嵌合抗原,应用双抗原夹心TRFIA检测TP特异性总抗体。评价该方法学的精密度、检测低限、准确度、线性、参考品符合率等分析性能指标,并进行临床比对试验研究,方法间结果差异比较采用χ~2检验,P<0.05为差异具有统计学意义。结果该方法的批内与批间的CV均不高于10%;检测低限可达0.05mIU/ml;检测国家标准物质的相对偏差不超过10%;在1.50~155.00mIU/ml内,线性相关系数可达0.999 9;检测国家参考品能达到检定要求;检测标化的血清盘结果符合率为100%;与梅毒螺旋体明胶凝集试验(TPPA)平行比对试验,总符合率为99.56%,Kappa指数为0.990 6。结论该方法精密度好、灵敏度高、准确性好、线性范围宽,临床符合率高,能满足临床检测需要。Objective To evaluation the performance of double antigen sandwich time-resolved fluoroimmunoassay（TRFIA）for specific total antibody to Treponema pallidum（TP）.Methods Specific total antibody to TP was detected by a double antigen TRFIA based on recombinant multi-epitope chimeric antigen.The methodological precision,low limit of detection,accuracy,linearity,reference standard coincidence rate and other analytical performance indicators were evaluated,and clinical comparison research trials were completed.The χ~2 test was used for the difference between two methods results,the P〈0.05 which represents the difference was statistically significant.Results The intra-assay and inter-assay coefficients of variation（CV）were both less than 10%respectively.The low limit of detection was 0.05 mIU/ml.The relative deviation of detecting the national standard was not exceed 10%.The linear range was 1.50~155.00 mIU/ml and the linear correlation coefficient could be reached 0.999 9.The performance of detection national reference could meet the national accreditation requirements.The consistent rate was 100% when the TRFIA methodology detected the standardized serum plate.The parallel test of TRFIA and treponema pallidum gelatin agglutination test（TPPA）were completed,the total coincidence rate was99.56%,and the Kappa index was 0.990 6.Conclusion Their result showed that the TRFIA methodology is high sensitivity,accuracy,wide linear range,and highly clinical coincidence rate,which is valuable for clinical application.

关 键 词：梅毒螺旋体 多表位嵌合抗原 双抗原夹心法 时间分辨荧光免疫法 性能评估 

分 类 号：R377.1[医药卫生—病原生物学] R446.61[医药卫生—基础医学]