中华皮肤科杂志 ›› 2018, Vol. 51 ›› Issue (5): 372-375.doi: 10.3760/cma.j.issn.0412-4030.2018.05.012

• 研究报道 • 上一篇    下一篇

梅毒IgA快速检测试剂诊断早期现症梅毒的应用性评估

韩燕1,魏万惠1,2,尹跃平3,David Anderson4,王红春1,Mary L Gacia4,Huy Van4,朱小宇1,陈凯1,陈祥生5   

  1. 1. 中国医学科学院皮肤病研究所
    2.
    3. 南京 中国医学科学院北京协和医学院皮肤病研究所
    4. Burnet Institute
    5. 医科院皮研所
  • 收稿日期:2018-01-09 修回日期:2018-03-05 出版日期:2018-05-15 发布日期:2018-05-02
  • 通讯作者: 尹跃平 E-mail:yinyp@ncstdlc.org
  • 基金资助:
    提高活动性梅毒的快速诊断，加速先天梅毒的消除进程;中国医学科学院皮肤医学与健康科技创新工程项目

Evaluation of prototype IgA rapid test on diagnosis of early active syphilis

  • Received:2018-01-09 Revised:2018-03-05 Online:2018-05-15 Published:2018-05-02
  • Contact: Yue-ping YIN E-mail:yinyp@ncstdlc.org
  • Supported by:
    Saving Lives at Birth partners and the Thrasher Research Fund;CAMS Innovation Fund for Medical Sciences

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摘要： 目的 评估Burnet研究所自制的IgA快速检测试剂（POC）对早期梅毒的诊断性能。方法 利用性病中心参比实验室库存的455份血清标本进行梅毒IgA-POC应用性评估，标本根据梅毒螺旋体血球凝集试验（TPHA）、快速血浆反应素环状卡片试验（RPR）及 IgM酶联免疫吸附试验（IgM-ELISA）结果分为未感染组、既往感染组和早期现症组。对3组标本进行IgA-POC盲样检测，评估其对现症梅毒的诊断能力。结果 IgA-POC对早期现症组的诊断灵敏度为92.6%（147/163），对既往感染组的排除诊断特异性为72.22%（104/144）；对未感染的排除诊断特异性为97.97%（145/148），总特异性为85.27%，达到了WHO对梅毒快速诊断试剂的最低要求。IgA-POC对早期现症梅毒诊断灵敏度高于IgM-ELISA（59.51%）（Z = 6.88，P < 0.05），但其对既往感染的排除诊断特异性低于IgM-ELISA（98.61%）（Z = 6.18，P < 0.05），两种方法对未感染的排除诊断特异性差异无统计学意义（Z = 1.16，P = 0.25）。结论 IgA-POC对早期现症梅毒的发现能力较IgM-ELISA强，可以应用于早期现症梅毒的筛查。

关键词: 梅毒, 梅毒血清诊断, 即时检验

Abstract: Han Yan, Wei Wanhui, Yin Yueping, David Anderson, Wang Hongchun, Mary L Garcia, Huy Van, Zhu Xiaoyu, Chen Kai, Chen Xiangsheng Reference Laboratory of STD, National Center for STD Control, China CDC; Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing 210042, China （Han Y, Wei WH, Yin YP, Wang HC, Zhu XY, Chen K）, National Center for STD Control （Chen XS）; Macfarlane Burnet Institute for Medical Research and Practical Action, Melbourne 3004, Australia （Anderson D, Garcia ML, Van H） Corresponding author: Yin Yueping, Email: yinyp@ncstdlc.org 【Abstract】 Objective To evaluate the application of Burnet Institute-made prototype IgA rapid test, a kind of point-of-care （POC） testing, in the diagnosis of early syphilis. Methods Totally, 455 stored serum samples in the Reference Laboratory of Sexually Transmitted Disease, the Institute of Dermatology were used to evaluate the application of the prototype IgA rapid test （IgA-POC） in the diagnosis of early syphilis. According to resluts of Treponema pallidum hemagglutination assay （TPHA）, rapid plasma reagin card test （RPR）, and enzyme-linked immunosorbent assay for IgM antibodies （IgM-ELISA）, these stored samples were divided into 3 groups: uninfected group, previously infected group and early active syphilis group. IgA-POC test was performed in the 3 groups to evaluate its diagnostic performance for active syphilis, and researchers were blind to the group information. Results The prototype IgA-POC test had a sensitivity of 92.6% （147/163） for the early active syphilis group, a specificity of 72.22% （104/144） for the previously infected group, and a specificity of 97.97% （145/148） for the uninfected group. The total specificity of the prototype IgA-POC test was 85.27%, which met the minimum requirement of WHO for the POC test. The prototype IgA-POC test showed a significantly higher sensitivity for the diagnosis of early active syphilis compared with the IgM-ELISA （59.51%, Z = 6.88, P < 0.05）, but a significantly lower specificity for the diagnosis of previous syphilis infection compared with the IgM-ELISA （98.61%, Z = 6.18, P < 0.05）. Moreover, no significant difference in the specificity for the diagnosis of non-infection was observed between the prototype IgA-POC test and IgM-ELISA （Z = 1.16, P = 0.25）. Conclusion The prototype IgA-POC test has better capacity for the diagnosis of early active syphilis compared with the IgM-ELISA, so it can be applied to the screening of early active syphilis.

Key words: Syphilis, Syphilis serodiagnosis, Point of care testing