ESAT-6/CFP-10复合物、ManLAM联合Xpert MTB/RIF Ultra对结核性脑膜炎的鉴别诊断价值OA
Diagnostic value of ESAT-6/CFP-10 complex,ManLAM,and Xpert MTB/RIF Ultra in the differential diag-nosis of tuberculous meningitis
目的 探讨早期分泌性抗原6(ESAT-6)/培养滤液蛋白10(CFP-10)复合物、甘露糖帽修饰的脂阿拉伯甘露聚糖(ManLAM)联合Xpert MTB/RIF Ultra(简称Xpert Ultra)检测在结核性脑膜炎(TBM)鉴别诊断中的价值.方法 本研究为回顾性研究,以2022年5月至2025年6月就诊的142例TBM患者(TBM组)和142例同期非TBM脑膜炎患者(对照组)为研究对象.收集所有研究对象的脑脊液标本,分别采用酶联免疫吸附试验(ELISA)检测ESAT-6/CFP-10复合物水平、侧流免疫层析法(LFA)检测ManLAM、实时荧光定量PCR法检测Xpert Ultra并对比两组间差异.比较各指标单独及联合检测的诊断效能(敏感度、特异度、阳性预测值、阴性预测值、准确率),绘制受试者工作特征(ROC)曲线及曲线下面积(AUC)评估各指标独立及联合鉴别诊断TBM的效能.结果 TBM组脑脊液ESAT-6/CFP-10复合物浓度、ManLAM阳性率、Xpert Ultra阳性率均显著高于对照组,差异均有统计学意义(P<0.05).在校正年龄、性别、基础疾病、临床特征等混杂因素后,多因素logistic回归分析表明脑脊液ESAT-6/CFP-10复合物浓度较高(OR=2.699,95%CI:1.646~4.427)、ManLAM 阳性(OR=6.961,95%CI:3.251~14.905)、Xpert Ultra 阳性(OR=5.648,95%CI:2.789~11.441)均为诊断TBM的独立影响因素(P<0.05).脑脊液ESAT-6/CFP-10复合物浓度、Man-LAM 阳性、Xpert Ultra阳性独立及联合诊断TBM的AUC分别为0.967、0.863、0.923、0.997,其中联合诊断效能高于 ManLAM 和 Xpert Ultra(Z=6.103、3.896,P<0.05),但与脑脊液 ESAT-6/CFP-10 复合物浓度的预测效能无显著差异(Z=0.267,P=0.789).脑脊液ESAT-6/CFP-10复合物的敏感度、特异度、PPV、NPV及准确度均高于ManLAM和Xpert Ultra.结论 脑脊液ESAT-6/CFP-10复合物浓度、ManLAM阳性率及Xpert Ultra阳性率在TBM患者中显著高于非TBM脑膜炎患者,且三者均为TBM诊断的独立影响因素;三者联合检测鉴别TBM的效能显著优于单独检测ManLAM或Xpert Ultra,可为临床TBM早期精准鉴别诊断提供可靠依据,有助于减少漏诊误诊.
Objective To evaluate the diagnostic performance of early secreted antigenic target 6(ESAT-6)/culture filtrate protein 10(CFP-10)complex,mannose-capped lipoarabinomannan(ManLAM),and Xpert MTB/RIF Ultra(Xpert Ultra)in the differential diagnosis of tuberculous meningitis(TBM).Methods This retrospective study included 142 patients with TBM(TBM group)and 142 patients with non-TBM meningitis(control group)admitted be-tween May 2022 and June 2025.Cerebrospinal fluid(CSF)samples were collected from all participants.The ESAT-6/CFP-10 complex concentration was measured using enzyme-linked immunosorbent assay(ELISA),ManLAM was de-tected by lateral flow assay(LFA),and Xpert Ultra was performed using real-time polymerase chain reaction.Differ-ences between groups were compared.Diagnostic performance-including sensitivity,specificity,positive predictive value(PPV),negative predictive value(NPV),and accuracy-was evaluated for individual and combined markers.Receiver operating characteristic(ROC)curves and area under the curve(AUC)were used to assess diagnostic efficacy.Results CSF ESAT-6/CFP-10 complex levels,ManLAM positivity rate,and Xpert Ultra positivity rate were all significantly higher in the TBM group than in the control group(P<0.05).After adjusting for confounding factors including age,sex,comorbidities,and clinical characteristics,multivariate logistic regression analysis identified elevated ESAT-6/CFP-10 complex concentration(OR=2.699,95%CI:1.646-4.427),positive ManLAM(OR=6.961,95%CI:3.251-14.905),and positive Xpert Ultra(OR=5.648,95%CI:2.789-11.441)as independent predictors for TBM diagnosis(P<0.05).The AUC values for ESAT-6/CFP-10 complex,ManLAM,Xpert Ultra,and their combination were 0.967,0.863,0.923,and 0.997,respectively.The combined model demonstrated significantly superior diagnostic per-formance compared with ManLAM or Xpert Ultra alone(Z=6.103 and 3.896,respectively;P<0.05),but showed no significant difference compared with ESAT-6/CFP-10 complex alone(Z=0.267,P=0.789).Notably,the ESAT-6/CFP-10 complex exhibited higher sensitivity,specificity,PPV,NPV,and overall accuracy than either ManLAM or Xpert Ultra.Conclusion CSF ESAT-6/CFP-10 complex levels,ManLAM positivity,and Xpert Ultra positivity are all significantly elevated in patients with TBM and serve as independent diagnostic indicators.Combined detection further im-proves diagnostic performance compared with ManLAM or Xpert Ultra alone,providing a reliable strategy for early and ac-curate differentiation of TBM,thereby reducing misdiagnosis and missed diagnosis.
马燕;马磊;高云;马涛;汪露
新疆医科大学第二附属医院检验科(新疆乌鲁木齐 830063)新疆医科大学第二附属医院心血管内科(新疆乌鲁木齐 830063)新疆医科大学第二附属医院检验科(新疆乌鲁木齐 830063)新疆医科大学第二附属医院检验科(新疆乌鲁木齐 830063)新疆医科大学第二附属医院检验科(新疆乌鲁木齐 830063)
医药卫生
结核性脑膜炎早期分泌性抗原6培养滤液蛋白10甘露糖帽修饰的脂阿拉伯甘露聚糖Xpert MTB/RIF Ultra
tuberculous meningitisearly secreted antigenic target 6culture filtrate protein 10mannose-capped lipoarabinomannanXpert MTB/RIF Ultra
《广东医学》 2026 (5)
696-702,7
新疆维吾尔自治区自然科学基金项目(2022D01C785)
评论