[1]吕松琴,孙溪若,黄　山,等.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[J].现代检验医学杂志,2021,36(06):152-156.[doi:10.3969/j.issn.1671-7414.2021.06.033]
　Lü Song-qin,SUN Xi-ruo,WANG Chao-nan,et al.Establishment of the Dry Fluorescence Method for Rapid Detection of Treponema Pallidum Antibody and Its Preliminary Application and Evaluation[J].Journal of Modern Laboratory Medicine,2021,36(06):152-156.[doi:10.3969/j.issn.1671-7414.2021.06.033]
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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()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第36卷
期数:
2021年06期
页码:
152-156
栏目:
研究简报·实验技术
出版日期:
2021-12-15

文章信息/Info

Title:
Establishment of the Dry Fluorescence Method for Rapid Detection of Treponema Pallidum Antibody and Its Preliminary Application and Evaluation
文章编号:
1671-7414（2021）06-152-05
作者:
吕松琴1; 孙溪若2; 黄　山1; 段洪芬1; 施金丽1; 李晓非1; 王超男3; 张　玲3; 王义娜2
（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）
Author(s):
Lü Song-qin;  SUN Xi-ruo;  WANG Chao-nan;  et al
（1. the Third People’s Hospital of Kunming / Clinical Center for Infectious Diseases in Yunnan Province, Kunming 650041, China; 2. Shanghai Rongsheng Biological Pharmaceutial Co. LTD, Shanghai 201108, China; 3. Medical Institute of Oriental Ocean (Beijing), Beijing 100071, China）
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；R446
DOI:
10.3969/j.issn.1671-7414.2021.06.033
文献标志码:
A
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0.009 8。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。
Abstract:
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 0.009 8, 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.

参考文献/References:

[1] GHANEM K G, RAM S, RICE P A. The modernepidemic of syphilis[J]. The New England Journal ofMedicine, 2020, 382(9): 845-854.
[2] WONG N S, HUANG Shujie, ZHENG Heping, et al.Stages of syphilis in South China – a multilevel analysisof early diagnosis[J]. BMC Public Health, 2017, 17(1):135.
[3] PEELING R W,MABEY D,KAMB M L,et al. Syphilis[J]. Nature Reviews Disease Primers, 2017, 3: 17073.
[4] 王可玲, 于艳妮, 刘鹏. 梅毒的临床分期特征及其实验室检测方法[J]. 医学信息, 2020, 33(6): 27-30.WANG Keling, YU Yanni, LIU Peng. Clinical stagingcharacteristics of syphilis and its laboratory detectionmethods [J]. Medical Information, 2020, 33(6): 27-30.
[5] WANG Kedi, XU Dongjiang, SU Jianrong. Preferableprocedure for the screening of syphilis in clinicallaboratories in China[J]. Infectious Diseases (London,England), 2016, 48(1): 26-31.
[6] 王欣俞，赵晋文，张延海，等．四种梅毒血清学检测方法在梅毒抗体不确定样本的分析及评价[J]. 现代检验医学杂志, 2019, 34(3): 109-111,114.WANG Xinyu, ZHAO Jinwen, ZHANG Yanhai, etal. Analysis and evaluation of four syphilis detectionmethods in uncertain samples of syphilis antibody [J].Journal of Modern Laboratory Medicine, 2019, 34(3):109-111,114.
[7] 金晶, 潘玥, 边春红, 等. 梅毒螺旋体特异性抗体试验方法探讨及临床应用价值评估[J]. 标记免疫分析与临床, 2021, 28(1): 27-31.JIN Jing, PAN Yue, BIAN Chunhong, et al. Anevaluation of Treponema pallidum specific antibody testmethod and its clinical application value [J]. LabeledImmunoassays and Clinical Medicine, 2021, 28(1): 27-31.
[8] 谢广澍. 梅毒螺旋体抗体血清学检测方法[J]. 医疗装备, 2019, 32(14): 39-40.XIE Guangshu. Serological methods for detection ofTreponema pallidum antibody [J]. Chinese Journal ofMedical Device, 2019, 32(14): 39-40.
[9] 杨浩, 蒙国煌, 张洪福, 等. 不同梅毒检验方法检测梅毒螺旋体准确率比较[J]. 现代诊断与治疗, 2018,29(10):1529-1530．YANG Hao, MENG Guohuang, ZHANG Hongfu, et al.Comparison of different syphilis examination methodsfor detection of Treponema pallidum accuracy[J].Modern Diagnosis and Treatment, 2018, 29(10): 1529-1530.
[10] 蓝蔚蔚，陈颖，蓝海鹰. 不同检测法对血清梅毒螺旋体抗体的检测价值[J]. 现代实用医学, 2020,32(5):479-481．LAN Weiwei, CHEN Ying, LAN Haiying. Clinicalvalue comparison of different methods for the detectionof serum Treponema pallidum antibody [J]. ModernPractical Medicine, 2020, 32(5): 479-481.
[11] 赖玉玲，黄丽芳，雷兴．时间分辨荧光免疫法检测梅毒螺旋体抗体的临床应用研究[J]．中国医药科学,2019, 9(7): 111-115.LAI Yuling, HUANG Lifang, LEI Xing. Researchon clinical application of time-resolved fluorescenceimmunoassay for detection of Treponema pallidumantibody[J]. China Medicine and Pharmacy, 2019, 9(7):111-115.
[12] 王欣俞, 崔凯, 赵晋文, 等. 免疫印迹法检测TPN15,TPN17,TPN45 和TPN47 抗体表达在梅毒诊断中的应用评估[J]. 现代检验医学杂志,2019,34(6)：82-85,89.WANG Xinyu, CUI Kai, ZHAO Jinwen, et al.Evaluation of the application of immunoblottingmethod for the detection of TPN15, TPN17, TPN45and TPN47 antibodies in the diagnosis of syphilis[J].Journal of Modern Laboratory Medicine, 2019, 34(6):82-85,89.
[13] 雷雪, 林勇平, 向波, 等. 多表位融合蛋白对减少梅毒抗体测定假反应性的作用[J]. 国际检验医学杂志,2021, 42(2): 197-201.LEI Xue, LIN Yongping, XIANG Bo, et al. Effectof multi-epitope fusion protein for resolving falsereactivity in syphilis antibody test[J]．InternationalJournal of Laboratory Medicine, 2021, 42(2): 197-201.
[14] MCGILL M A, EDMONDSON D G, CARROLL JA, et al. Characterization and serologic analysis ofthe Treponema pallidum proteome[J].Infection andImmunity, 2010, 78(6): 2631-2643.
[15] 谭玉华, 雷泽洪, 郑丹, 等. 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[J]. 现代检验医学杂志, 2018, 33(2): 97-100.TAN Yuhua, LEI Zehong, ZHENG Dan, et al.Evaluation of double antigen sandwich time-resolvedfluoroimmunoassay for specific total antibodies toTreponema pallidum [J]. Journal of Modern LaboratoryMedicine, 2018, 33(2): 97-100.

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更新日期/Last Update: 1900-01-01