舌拭子-PCR荧光探针法对肺结核诊断效能的评价  

Evaluation the efficacy of tongue swab-based PCR fluorescence probe method for pulmonary tuberculosis

作　　者：陈纪飞 黄丽花 罗兰波 眭文娴 逄宇 刘爱梅 Chen Jifei;Huang Lihua;Luo Lanbo;Sui Wenxian;Pang Yu;Liu Aimei(Department of Science and Education and GCP Institutional Office,Guangxi Zhuang Autonomous Region Chest Hospital,Liuzhou 545005,China;Department of Laboratory Medicine,Guangxi Zhuang Autonomous Region Chest Hospital,Liuzhou 545005,China;Bacterial Immunology Laboratory,Beijing Chest Hospital,Capital Medical University,Beijing 101149,China)

机构地区：[1]广西壮族自治区胸科医院科教科、药物临床试验机构办公室,柳州545005 [2]广西壮族自治区胸科医院检验科,柳州545005 [3]首都医科大学附属北京胸科医院细菌免疫室,北京101149

出　　处：《中国防痨杂志》2025年第1期51-60,共10页Chinese Journal of Antituberculosis

基　　金：广西科技重大专项(桂科AA22096027)。

摘　　要：目的:评估舌拭子-PCR荧光探针法(舌拭子法)的肺结核诊断效能,分析各肺结核诊断方法的一致性,探讨舌拭子法在肺结核诊断中的应用价值。方法:采用前瞻性研究,连续收集2024年1—3月在广西胸科医院就诊的疑似肺结核患者76例。记录患者临床症状及痰涂片、痰液GeneXpert MTB/RIF(Xpert)、结核感染T淋巴细胞斑点试验等实验室检查结果。舌拭子法使用结核分枝杆菌复合群核酸检测试剂盒。参考痰培养或复合微生物学标准(microbiological reference standard,MRS),通过基线比较、单变量ROC分析、变量相关性分析、Lasso回归和森林图,遴选高诊断效能参数、拟合肺结核诊断模型。通过一致性检验分析舌拭子法与Xpert、痰培养、痰涂片、MRS等肺结核诊断方法的差异。结果:参考痰培养,Xpert(χ^(2)=49.045,P<0.001)、舌拭子法(χ^(2)=42.626,P<0.001)、痰涂片(χ^(2)=17.443,P<0.001)在痰培养阳性和阴性组间差异有统计学意义,受试者工作特征曲线下面积(AUC)由大到小依次为Xpert(AUC=0.902)、舌拭子法(AUC=0.875)、痰涂片(AUC=0.709);模型拟合显示,Xpert联合舌拭子法为最优诊断模型;单变量ROC及ROC对比分析显示,Xpert优于舌拭子法(AUC分别为0.902和0.875,敏感度分别为87.10%和83.87%,特异度分别为93.33%和91.11%,P值均<0.001),但差异无统计意义(Z=0.795,P=0.427)。参考MRS,舌拭子法(χ^(2)=46.723,P<0.001)、痰涂片(χ^(2)=23.262,P<0.001)在MRS阳性和阴性组间差异均有统计学意义,AUC由大到小依次为舌拭子法(AUC=0.888)、痰涂片(AUC=0.738);模型拟合遴选舌拭子法为最优诊断模型;单变量ROC及ROC对比分析显示,舌拭子法明显优于痰涂片(AUC分别为0.888和0.738,敏感度分别为82.35%和50.00%,特异度分别为95.24%和97.62%,P值均<0.001),两者差异有统计学意义(Z=2.889,P=0.004)。舌拭子法与MRS(Kappa=0.7847)和Xpert(Kappa=0.8348)一致性均较高,且与Xpert各分层的一致性好,总体一致率�Objective:To evaluate the diagnostic accuracy of tongue swab-based PCR fluorescence probe method for pulmonary tuberculosis(PTB),analyze the consistency across various PTB diagnostic methods,and explore its application value in the diagnosis of PTB.Methods:A prospective study was conducted to recruit 76 suspected PTB patients who sought health care in Guangxi Chest Hospital from January to March 2024.Clinical symptoms and laboratory results,including sputum smear microscopy,GeneXpert MTB/RIFXpert,and tuberculous infection T-lymphocyte spot tests,were collected.The tongue swab method utilized a nucleic acid detection kit for Mycobacterium tuberculosis complex.Using sputum culture or microbiological reference standard(MRS)as reference standard,parameters with high diagnostic efficacy were selected through baseline comparison,univariate ROC analysis,variable correlation analysis,Lasso regression,and forest plots to fit a model for PTB diagnosis consistency analysis was conducted to compare the tongue swab method with the existing PTB diagnostic methods including Xpert,sputum culture,and smear.Results:Using sputum culture as the reference,there were statistically significant differences among Xpert(χ^(2)=49.045,P<0.001),tongue swab method(χ^(2)=42.626,P<0.001),and sputum smear(χ^(2)=17.443,P<0.001)between positive and negative groups.AUCs were ranked as follows:Xpert(AUC=0.902),tongue swab method(AUC=0.875),and sputum smear(AUC=0.709).Model fitting indicated that Xpert combined with the tongue swab method was the optimal diagnostic model.Univariate ROC and comparative analysis showed that Xpert outperformed the tongue swab method(AUCs of 0.902 and 0.875,sensitivities of 87.10% and 83.87%,specificities of 93.33% and 91.11%,respectively;P<0.001 for both),although the difference was not statistically significant(Z=0.795,P=0.427).Using MRS as a reference,significant differences were found for the tongue swab method(χ^(2)=46.723,P<0.001)and sputum smear(χ^(2)=23.262,P<0.001)between MRS positive and negative groups,wi

关 键 词：舌拭子 分枝杆菌 结核 聚合酶链反应 评价研究 数据说明 统计 

分 类 号：R52[医药卫生—内科学]