磁微粒化学发光法与梅毒螺旋体颗粒凝集实验联合检测在梅毒诊断中的应用价值

doi:10.3969/j.issn.1671-7171.2025.06.026

摘要
图/表
参考文献
相关文章 (13)

全文: PDF (1289 KB) HTML (1 KB)
输出: BibTeX | EndNote (RIS)

摘要【目的】探讨磁微粒化学发光法(CMIA)与梅毒螺旋体颗粒凝集实验(TPPA)联合检测在梅毒诊断中的应用价值。【方法】采集经临床确诊为梅毒的40例患者及40例健康体检者的静脉血,分别进行CMIA、TPPA梅毒检测。比较两种方法的相关检测结果,根据CMIA测得的S/CO值将受检者进行分组,比较各组的TPPA的检测结果。【结果】80例受检者中CMIA阳性41例,阴性39例;TPPA阳性38例,阴性42例。CMIA和TPPA两种检测结果比较,差异无统计学意义(P>0.05)。CMIA检测的灵敏度为100.00%,特异性为97.50%,阳性预测率97.56%,阴性预测率100.00%,准确率为98.75%,Kappa=0.975,CMIA与临床检测结果比较,差异无统计学意义(P>0.05);TPPA检测的灵敏度为95.00%,特异性为100.00%,阳性预测率100.00%,阴性预测率95.24%,准确率为97.50%,Kappa=0.950,TPPA与临床检测结果比较,差异亦无统计学意义(P>0.05)。CMIA与TPPA的一致率为96.25%,Kappa=0.925(P>0.05)。TPPA阳性率随S/CO值增大而升高,当S/CO>7时,TPPA阳性率为100.00%。【结论】CMIA与TPPA检测在梅毒诊断中均具有较高的敏感性、特异性及准确性。TPPA检测在高S/CO值范围内的阳性率显著增加,基于S/CO阈值的分层策略显示,高S/CO值(>7)可直接确诊梅毒,无需进行TPPA复检,减少检测时间与成本;而S/CO≤7者需TPPA验证。优化该流程可提升诊断效率,适用于大规模筛查。

	服务

	把本文推荐给朋友
	加入我的书架
	加入引用管理器
	E-mail Alert
	RSS
	作者相关文章
	何哲
	张丽梅
	刘乘果

关键词 ：梅毒, 发光测定法, 梅毒血清诊断

Abstract：【Objective】 To explore the diagnostic value of combining chemiluminescent microparticle immunoassay (CMIA) and Treponema pallidum particle agglutination assay (TPPA) in the diagnosis of syphilis.【Methods】 Venous blood samples were collected from 40 clinically confirmed syphilis patients and 40 healthy individuals. All samples were tested using both CMIA and TPPA. The results of the two methods were compared. Subjects were also grouped based on CMIA derived S/CO values, and TPPA results were compared across these groups.【Results】Among the 80 subjects, CMIA detected 41 positives and 39 negatives; TPPA detected 38 positives and 42 negatives. There was no statistically significant difference between the results of CMIA and TPPA (P>0.05). The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of CMIA were 100.00%, 97.50%, 97.56%, 100.00%, and 98.75%, respectively, with a Kappa value of 0.975. Compared with clinical diagnosis, there was no significant difference (P>0.05). The corresponding values for TPPA were 95.00%, 100.00%, 100.00%, 95.24%, and 97.50%, respectively, with a Kappa value of 0.950, also showing no significant difference from clinical diagnosis (P>0.05). The concordance rate between CMIA and TPPA was 96.25%, with a Kappa value of 0.925 (P>0.05). TPPA positivity increased with higher S/CO values. When S/CO > 7, TPPA positivity reached 100.00%.【Conclusion】 Both CMIA and TPPA exhibit high sensitivity, specificity, and accuracy in syphilis diagnosis. TPPA positivity increases significantly with higher S/CO values. A stratified diagnostic approach based on an S/CO threshold suggests that high S/CO(>7) cases can be directly diagnosed following CMIA screening without TPPA confirmation, thereby reducing detection time and cost. TPPA verification remains necessary for cases with S/CO ≤ 7. This optimized diagnostic workflow can improve efficiency and is well-suited for large-scale screening programs.

Key words： Syphilis Luminescent Measurements Syphilis Serodiagnosis

收稿日期: 2025-03-10

中图分类号:

R759.1

引用本文:

何哲, 张丽梅, 刘乘果. 磁微粒化学发光法与梅毒螺旋体颗粒凝集实验联合检测在梅毒诊断中的应用价值[J]. 医学临床研究, 2025, 42(6): 1004-1006.
HE Zhe, ZHANG Limei, LIU Chengguo. Application Value of Combined Detection of Chemiluminescent Microparticle Immunoassay and Treponema Pallidum Particle Agglutination Test in the Diagnosis of Syphilis. JOURNAL OF CLINICAL RESEARCH, 2025, 42(6): 1004-1006.

链接本文:

http://journal07.magtech.org.cn/yxlcyj/CN/10.3969/j.issn.1671-7171.2025.06.026 或 http://journal07.magtech.org.cn/yxlcyj/CN/Y2025/V42/I6/1004

[1] PEELING R W, MABEY D, CHEN X S, et al. Syphilis[J].Lancet,2023,402(10398):336-346.
[2] 殷欢,王继超,吴凤,等. 化学发光微粒子免疫分析法检测孕妇梅毒特异性抗体的应用评价[J].中国艾滋病性病,2021,27(5):508-511.
[3] 李钰,郭金珠. IFN-γ、IL-10、E₂、β-hCG在妊娠合并梅毒患者血清中的表达水平及其临床意义[J].医学临床研究,2022,39(3):386-389.
[4] SERNICOLA A, MADDALENA P, LA GRECA I, et al. False negative RPR test with prozone phenomenon in an HIV-negative man with secondary syphilis[J].J Eur Acad Dermatol Venereol,2022,36(8):e628-e629.
[5] 王欣俞,赵晋文,焦曼玉,等. 梅毒免疫印迹法在梅毒血清固定患者诊断中的临床应用[J].医学综述,2020,26(24):4957-4961.
[6] 李永涛,李坤苓,丁艳梅,等. 磁微粒化学发光法检测梅毒螺旋体特异性抗体在临床筛查中的应用[J].中国卫生检验杂志,2019,29(5):577-579.
[7] KRISHNAPURA LAKSHMINARAYANA S, DEVADAS S, BHARATH K, et al. Early congenital syphilis: missed opportunities in a mother owing to many problems during pregnancy-a case report[J].Paediatr Int Child Health,2022,42(2):89-94.
[8] 李楠,孙萍萍,王翠,等. 3种血清学特异性抗体检测在梅毒螺旋体检测中的比较研究[J].中国实验诊断学,2021,25(1):64-66.
[9] 邵淑丽,李秋静,耿建利,等. 全自动粒子化学发光法在梅毒抗体筛查中的应用与分析[J].国际检验医学杂志,2020,41(2):138-140.
[10] 彭振亚,张银辉,陈安宁,等. 变性梅毒重组抗原免疫印迹技术的建立及其在鉴别梅毒血清学假阳性实验的应用[J].现代检验医学杂志,2023,38(2):150-154.
[11] 王娟梅,方孝美,宋冰. 三种梅毒螺旋体特异性抗体检测方法性能评价[J].中国麻风皮肤病杂志,2021,37(12):768-771.
[12] 柳霞,徐国宾. 肿瘤专科医院机会性感染筛查患者梅毒螺旋体血清学试验阳性率调查[J].标记免疫分析与临床,2022,29(5):753-756.
[13] CHOPRA S, KRASOWSKI M D. Data on the relationships of signal-to-cutoff ratios of elecsys HIV antigen/antibody and elecsys syphilis assays to subsequent confirmatory testing at an academic medical center[J].Data Brief,2021,39(3):475-480.
[14] 刘静,安荣真,郭科. 某综合医院皮肤性病科门诊梅毒感染分析[J].实用皮肤病学杂志,2024,17(4):211-213.