田晓波; 金静; 文江平; 吴薇; 刘向祎

doi:10.3760/cma.j.cn311365-20200520-00613

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梅毒血清反应假阳性的影响因素

中华传染病杂志, 2021,39(4) : 224-227. DOI: 10.3760/cma.j.cn311365-20200520-00613

摘要

目的

探讨梅毒血清反应假阳性的影响因素。

方法

纳入2017年1月至2020年2月首都医科大学附属北京同仁医院梅毒血清反应假阳性患者166例(假阳性组)，诊断为早期梅毒且未经治疗的患者145例(阳性对照组)，入职体检者124名(阴性对照组)。比较3组研究对象的性别、年龄和合并基础疾病情况，采用logistic回归分析梅毒血清反应假阳性的影响因素。比较化学发光免疫分析法(chemiluminescence immunoassay，CLIA)与甲苯胺红不加热血清试验(toluidine red unheated serum test，TRUST)的梅毒血清试验效能。统计学处理采用配对样本t检验或χ²检验。

结果

166例假阳性组患者中，年龄≥50岁117例，年龄<50岁49例。假阳性组与阴性对照组比较，年龄[(53.1±13.8)岁比(24.7±2.8)岁，t＝22.56，P<0.01]、自身免疫病[36.7%(61/166)比6.5%(8/124),χ²＝35.93，P<0.01]、肝炎[9.6%(16/166)比3.2%(4/124),χ²＝4.92，P＝0.026]和肿瘤[6.6%(11/166)比0.8%(1/124), χ²＝4.68，P＝0.030]差异均有统计学意义；假阳性组与阳性对照组比较，性别[假阳性组男91例(54.8%)，女75例(45.2%)，阳性对照组男103例(71.0%)，女42例(29.0%); χ²＝8.67，P＝0.003]、年龄[(53.1±13.8)岁比(34.4±12.9)岁，t＝20.13，P<0.01]及自身免疫病[36.7%(61/166)比6.9%(10/145)，χ²＝39.14，P<0.01]差异均有统计学意义。多因素logistic回归分析显示，性别[比值比(odds ratio,OR)＝2.692，95%可信区间(confidence interval, CI)1.504～4.816，P＝0.001]、年龄≥50岁(OR＝30.512，95%CI 15.959～58.335，P<0.01)、自身免疫病(OR＝2.677，95%CI 1.258～5.695，P＝0.011)和肝炎(OR＝4.408，95%CI 1.799～10.799，P＝0.001)是梅毒血清假阳性的影响因素。假阳性组中，TRUST的阳性率为84.9%(141/166)，高于CLIA的23.5%(39/166)，差异有统计学意义(χ²＝126.25，P<0.01)；36例患者CLIA为1.0～10.0临界指数(cut off index, COI)，3例患者CLIA>10.0 COI，差异有统计学意义(χ²＝52.51，P<0.01)；139例患者TRUST≤1∶4阳性，2例患者TRUST≥1∶8阳性，差异有统计学意义(χ²＝262.35，P<0.01)。CLIA的灵敏度和特异度分别为95.2%和96.0%，TRUST的灵敏度和特异度分别为77.2%和91.1%。

结论

患者年龄≥50岁、有自身免疫病或肝炎是发生梅毒血清反应假阳性的影响因素，TRUST的假阳性率高于CLIA。

引用本文: 田晓波, 金静, 文江平, 等. 梅毒血清反应假阳性的影响因素 [J] . 中华传染病杂志, 2021, 39(4) : 224-227. DOI: 10.3760/cma.j.cn311365-20200520-00613.

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梅毒血清试验包括梅毒螺旋体试验(检测特异性抗体)和非梅毒螺旋体试验(检测非特异性抗体)，实验室通常采用化学发光免疫分析法(chemiluminescence immunoassay，CLIA)检测特异性抗体，采用甲苯胺红不加热血清试验(toluidine red unheated serum test，TRUST)检测非特异性抗体。无论是特异性抗体的检测还是非特异性抗体的检测均会出现假阳性或假阴性，所以这两种试验的阳性结果均需增加另一种特异性抗体试验进行确证，临床上通常选用梅毒螺旋体明胶凝集试验(treponema pallidum particle agglutination，TPPA)作为初筛方案的确证试验^[1,2]。老年人或孕妇因机体抵抗力下降更易感染病毒和细菌，患有某些疾病如自身免疫病和肿瘤的患者体内有一些干扰物质或者抗体也会与检测试剂产生反应，这些因素都会影响梅毒血清试验的检测结果^[3,4,5,6]。本研究比较CLIA和TRUST在梅毒诊断中的差异，以期提高梅毒诊断的准确性。

贡献者信息

田晓波

首都医科大学附属北京同仁医院检验科　100176

金静

首都医科大学附属北京同仁医院检验科　100176

文江平

首都医科大学附属北京同仁医院检验科　100176

吴薇

首都医科大学附属北京同仁医院检验科　100176

刘向祎

首都医科大学附属北京同仁医院检验科　100176

通信作者

刘向祎

首都医科大学附属北京同仁医院检验科　100176

Email：2663219350@qq.com

关键词

梅毒; 假阳性反应; 影响因素; 非梅毒特异性抗体;

基金项目

国家自然科学基金（81371861）

作者声明

作者贡献声明

田晓波：论文撰写；金静：数据采集；文江平：统计学分析；吴薇：数据整理；刘向祎：课题设计、研究指导

利益冲突

所有作者均声明不存在利益冲突

历史

出版日期：2021-04-15

收稿日期：2020-05-20

本文编辑

李欣

Original Article

Influencing factors of false-positive serological reaction of syphilis

Tian Xiaobo, Jin Jing, Wen Jiangping, Wu Wei, Liu Xiangyi

Published 2021-04-15

Cite as Chin J Infect Dis, 2021, 39(4): 224-227. DOI: 10.3760/cma.j.cn311365-20200520-00613

Abstract

Objective

To explore the influencing factors of false-positive serological reaction of syphilis.

Methods

A total of 166 patients with false-positive serological reaction of syphilis (false-positive group), 145 patients diagnosed with early syphilis without treatment (positive control group) and 124 persons undergoing entry physical examination (negative control group) were included from January 2017 to February 2020 in Beijing Tongren Hospital, Capital Medical University. The gender, age and underlying diseases of the three groups were compared. Logistic regression was used to analyze the influencing factors of false-positive serological reaction of syphilis. The efficacies of chemiluminescence immunoassay (CLIA) and toluidine red unheated serum test (TRUST) were compared. Paired t test or chi-square test was used for statistical analysis.

Results

In the false-positive group (166 cases), the age of 117 cases were more than 50 years old and 49 cases <50 years old. There were significant differences in age ((53.1±13.8) vs (24.7±2.8), t=22.56, P<0.01), autoimmune disease (36.7%(61/166)vs 6.5%(8/124), χ²=35.93, P<0.01), hepatitis (9.6%(16/166)vs 3.2%(4/124), χ²=4.92, P=0.026) and tumor (6.6%(11/166) vs 0.8%(1/124), χ²=4.68, P=0.030) between the false-positive group and the negative control group. There were significant differences in gender (there were 91(54.8%) males and 75(45.2%) females in the false-positive group, and 103(71.0%) males and 42(29.0%) females in the positive control group, χ²=8.67, P=0.003), age ((53.1±13.8) vs (34.4±12.9), t=20.13, P<0.01) and autoimmune disease (36.7%(61/166)vs 6.9%(10/145), χ²=39.14, P<0.01) between the false-positive group and the positive control group. Multivariate logistic regression analysis showed that gender (odds ratio (OR)=2.692, 95% confidence interval (CI) 1.504-4.816, P=0.001), age ≥50 years old (OR=30.512, 95%CI 15.959-58.335, P<0.01), autoimmune disease (OR=2.677, 95%CI 1.258-5.695, P=0.011) and hepatitis (OR=4.408, 95%CI 1.799-10.799, P=0.001) were the influencing factors of false-positive serological reaction of syphilis. In the false-positive group, the positive rate of TRUST was 84.9% (141/166), which was higher than that of CLIA (23.5%(39/166)). The difference was statistically significant (χ²=126.25, P<0.01). CLIA was 1.0-10.0 cut off index (COI) in 36 patients, and >10.0 COI in three patients.The difference was statistically significant (χ²=52.51, P<0.01). The titers were ≤1∶4 in 139 patients and≥1∶8 in two patients with TRUST positive.The difference was statistically significant (χ²=262.35, P<0.01). The sensitivity and specificity of CLIA were 95.2% and 96.0%, respectively, and those of TRUST were 77.2% and 91.1%, respectively.

Conclusions

The influencing factors of false-positive serological reaction of syphilis include patients age ≥50 years and with autoimmune disease or hepatitis. The false-positive rate of TRUST is significantly higher than CLIA.

Key words:

Syphilis; False-positive reactions; Influence factors; Non-specific antibody to syphilis

Contributor Information

Tian Xiaobo