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Application Value of Combined Detection of Chemiluminescent Microparticle Immunoassay and Treponema Pallidum Particle Agglutination Test in the Diagnosis of Syphilis |
HE Zhe, ZHANG Limei, LIU Chengguo |
Department of Clinical Laboratory, Kaifeng People's Hospital, Kaifeng Henan 475003 |
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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.
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Received: 10 March 2025
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[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. |
[1] |
. [J]. JOURNAL OF CLINICAL RESEARCH, 2024, 41(1): 113-116. |
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