干式荧光发光法快速检测梅毒螺旋体抗体的方法建立和初步应用与评价  

Establishment of the Dry Fluorescence Method for Rapid Detection of Treponema Pallidum Antibody and Its Preliminary Application and Evaluation

作　　者：吕松琴 孙溪若 黄山 段洪芬 施金丽 李晓非 王超男 张玲 王义娜 LÜSong-qin;SUN Xi-ruo;HUANG Shan;DUAN Hong-fen;SHI Jin-li;LI Xiao-fei;WANG Chao-nan;ZHANG Ling;WANG Yi-na(the Third People’s Hospital of Kunming/Clinical Center for Infectious Diseases in Yunnan Province,Kunming 650041,China;Shanghai Rongsheng Biological Pharmaceutial Co.LTD,Shanghai 201108,China;Medical Institute of Oriental Ocean(Beijing),Beijing 100071,China)

机构地区：[1]昆明市第三人民医院/云南省传染性疾病临床医学中心,昆明650041 [2]上海荣盛生物药业有限公司,上海201108 [3]东方海洋(北京)医学研究院,北京100071

出　　处：《现代检验医学杂志》2021年第6期152-156,共5页Journal of Modern Laboratory Medicine

摘　　要：目的建立一种干式荧光发光法快速检测梅毒螺旋体(Treponema pallidum,TP)总抗体的检测技术,并评价其检测性能。方法利用高活性优势表位嵌合TP抗原,基于免疫层析和荧光发光平台,采用双抗原夹心原理建立检测梅毒螺旋体总抗体的快速检测方法。应用该方法检测梅毒螺旋体抗体快速试剂国家参考品,并与酶联免疫法平行检测360例临床样本,比较评价该技术的检测性能。结果建立了梅毒螺旋体总抗体干式荧光发光快速检测技术,检测国家参考品10份阳性参考品符合率为10/10,20份阴性参考品符合率为19/20,三批产品的批内重复性分别为12.00%,12.30%和9.10%,批间重复性为10.90%,最低检测限参考品L1和L2检测为阳性,L3检测为阴性。在临床样本评价中,该检测技术诊断梅毒患者的AUC值为0.986,敏感度和特异度分别为99.08%和94.02%,阳性预测值和阴性预测值分别为87.80%和99.58%,阳性似然比和阴性似然比分别为16.569和0.0098。与酶联免疫法检测试剂相比较,总体符合率为98.06%(Kappa=0.965),具有高度等效性。结论本研究建立的梅毒螺旋体抗体干式荧光发光快速检测技术是一种敏感度和特异度均高的检测方法,能够满足临床检测需要。Objective To establish a dry fluorescent dry fluorescent luminescence technique for the detection of Treponema pallidum(TP)total antibody and evaluate its detection performance.Methods Anti-treponema pallidum total antibody was detected by the dry fluorescent dry fluorescent luminescence technique established using highly active dominant epitope chimeric TP antigen.A total of 360 clinical samples were tested in parallel with enzyme-linked immunoassay(ELISA)to evaluate the performance of the dry fluorescent luminescence technique.Results The coincidence rate of 10 positive reference samples was 10/10,and the coincidence rate of 20 negative reference samples was 19/20.The intra-batch reproducibility of the three batches was 12.00%,12.30%and 9.10%,respectively,and the inter-batch reproducibility was 10.90%.The minimum limit of detection was positive for L1 and L2,and negative for L3.In clinical performance evaluation,the AUC value was 0.986,and the sensitivity and specificity of the dry fluorescent luminescence technique were 99.08%and 94.84%,respectively.The positive predictive value and the negative predictive value were 87.8%and 99.58%respectively.The positive likelihood ratio and the negative likelihood ratio were 16.569 and 0.0098,respectively.The overall coincidence rate between dry fluorescent luminescence method and ELISA was 98.06%(Kappa=0.965).Conclusion The dry fluorescence luminescence technique of Treponema pallidum total antibody is a rapid detection method with high sensitivity and specificity,which can meet the needs of clinical detection.

关 键 词：梅毒螺旋体 干式荧光发光法 优势表位嵌合TP抗原 性能评价 

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