中华皮肤科杂志 ›› 2026, Vol. 59 ›› Issue (4): 370-373.doi: 10.35541/cjd.20250041

• 技术与方法 • 上一篇    下一篇

磁微粒化学发光法检测梅毒特异性抗体的复检范围探讨研究

王碧伟    李赛    乐文静    赵诗轩    陈雅丽    赵园园    甘璐    朱小凤    苏晓红   

  1. 中国医学科学院、北京协和医学院皮肤病医院性病科，南京  210042
  • 收稿日期:2025-01-23 修回日期:2026-01-12 发布日期:2026-04-03
  • 通讯作者: 苏晓红 E-mail:suxh@ncstdlc.org
  • 基金资助:
    中国医学科学院医学与健康科技创新工程项目（CIFMS-2021-I2M-1-001）

Identification of signal-to-cutoff value ranges by chemiluminescent microparticle immunoassay required for the retest of syphilis-specific antibodies

Wang Biwei, Li Sai, Le Wenjing, Zhao Shixuan, Chen Yali, Zhao Yuanyuan, Gan Lu, Zhu Xiaofeng, Su Xiaohong   

  1. STD Clinic, Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences ＆ Peking Union Medical College, Nanjing 210042, China
  • Received:2025-01-23 Revised:2026-01-12 Published:2026-04-03
  • Contact: Su Xiaohong E-mail:suxh@ncstdlc.org
  • Supported by:
    CAMS Innovation Fund for Medical Sciences（CIFMS-2021-I2M-1-001）

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摘要： 【摘要】 目的 探讨磁微粒化学发光法（CMIA）检测梅毒特异性抗体的复检范围。方法 本研究为回顾性病例系列研究，回顾2020年7月至2024年6月间在中国医学科学院皮肤病医院进行梅毒抗体检测的患者资料。以梅毒螺旋体明胶凝集试验（TPPA）为确认试验,分析CMIA法不同发光值/截断值（S/CO值）范围对梅毒抗体的阳性预测值及阴性预测值，探讨CMIA法检测梅毒抗体的复检范围；对两种试验结果不一致患者的临床资料进行分析，总结该部分患者的特点。结果 1 735例采用CMIA法初检梅毒特异性抗体，男1 153例，女582例，年龄1 ~ 95（46.29 ± 17.46）岁；其中160例CMIA法阴性（S/CO＜1）样本，经TPPA确认结果均为阴性，1 575例CMIA法阳性（S/CO ≥ 1）样本，经TPPA确认1 485例（94.29）阳性，90例阴性；根据CMIA法S/CO值将1 575例样本分为1 ~＜3、3 ~＜5、5 ~＜7、7 ~＜9、9 ~＜11、 ≥ 11共6组，各组TPPA阳性率随着S/CO值升高逐渐升高，S/CO值区间由1 ~＜3升至7 ~＜9时，CMIA法阳性预测值由36.08%升至96.88%，S/CO值 ≥ 9时CMIA法阳性预测值为100.00%。本研究共有90例（5.19%）CMIA法与TPPA检测结果不一致，均为CMIA初筛阳性（S/CO值1.004 ~ 8.137），TPPA阴性。结论 CMIA法初筛梅毒特异性抗体的复检范围可设置为S/CO值1 ~＜9，S/CO值 ≥ 9或 < 1时不需要进行TPPA复检试验；对于CMIA初筛阳性而TPPA复检阴性的病例，需结合临床体征、流行病学史等综合评估。

关键词: 梅毒, 梅毒血清诊断, 磁微粒化学发光法, 梅毒螺旋体明胶凝集试验

Abstract: 【Abstract】 Objective To investigate the appropriate signal-to-cutoff （S/CO） value ranges by chemiluminescent microparticle immunoassay （CMIA） required for the retest of syphilis-specific antibodies. Methods This study was a retrospective case series study. Data were collected from patients who underwent syphilis antibody testing at the Hospital for Skin Diseases, Chinese Academy of Medical Sciences between July 2020 and June 2024. The Treponema pallidum particle agglutination assay （TPPA） served as the confirmatory test. The positive predictive value and negative predictive value of CMIA for the detection of syphilis antibodies across different ranges of S/CO values were analyzed to determine the appropriate retest range. In addition, the clinical characteristics of patients with discordant results between CMIA and TPPA were analyzed and summarized. Results A total of 1 735 samples were tested for syphilis-specific antibodies using CMIA, which were collected from 1 153 males and 582 females, aged 1 - 95 （46.29 ± 17.46） years. Among them, 160 samples were CMIA-negative （S/CO < 1）, and all were confirmed negative by TPPA; of the 1 575 CMIA-positive samples （S/CO ≥ 1）, 1 485 （94.29%） were TPPA-positive, while 90 were TPPA-negative. Based on the S/CO values, the 1 575 CMIA-positive samples were divided into 6 groups according to the following ranges: 1 - < 3, 3 - < 5, 5 - < 7, 7 - < 9, 9 - < 11, and ≥ 11. The TPPA positivity rates increased progressively with increasing S/CO values. As the S/CO range increased from 1 - < 3 to 7 - < 9, the positive predictive value of CMIA increased from 36.08% to 96.88%, reaching 100.00% when S/CO ≥ 9. A total of 90 cases （5.19%） showed discordant results between CMIA and TPPA, all of which were CMIA-positive （S/CO values: 1.004 - 8.137） but TPPA-negative. Conclusions The retest of syphilis-specific antibodies may be required when the S/CO values by CMIA are 1 - < 9, while TPPA retest may not be required when the S/CO values are ≥ 9 or < 1. For cases with CMIA-positive but TPPA-negative results, comprehensive evaluation should be performed in conjunction with clinical manifestations and epidemiological history.

Key words: Syphilis, Syphilis serodiagnosis, Chemiluminescent microparticle immunoassay, Treponema pallidum particle agglutination

引用本文

王碧伟 李赛 乐文静 赵诗轩 陈雅丽 赵园园 甘璐 朱小凤 苏晓红. 磁微粒化学发光法检测梅毒特异性抗体的复检范围探讨研究[J]. 中华皮肤科杂志, 2026,59(4):370-373. doi:10.35541/cjd.20250041

Wang Biwei, Li Sai, Le Wenjing, Zhao Shixuan, Chen Yali, Zhao Yuanyuan, Gan Lu, Zhu Xiaofeng, Su Xiaohong. Identification of signal-to-cutoff value ranges by chemiluminescent microparticle immunoassay required for the retest of syphilis-specific antibodies[J]. Chinese Journal of Dermatology, 2026, 59(4): 370-373.doi:10.35541/cjd.20250041