舌拭子结核分枝杆菌核酸检测在疑似肺结核患者中的诊断价值

Value of tongue swab-based Mycobacterium tuberculosis nucleic acid testing in diagnosis of patients with suspected pulmonary tuberculosis

  • 摘要: 目的 评估舌拭子PCR检测在疑似肺结核患者中的诊断效能,分析痰菌载量及采样时间对检测性能的影响。方法 前瞻性纳入2025年9月至2026年2月于南宁市第四人民医院结核科住院的185例疑似肺结核患者,以痰Xpert为参考标准,计算舌拭子检测的敏感性、特异性、预测值及准确率,采用Clopper-Pearson法计算95%CI,采用Kappa一致性检验评估两种方法的一致性。根据痰Xpert半定量结果(高、中、低、极低)进行亚组分析,分析不同痰菌载量对诊断效能的影响; 同时按取样时间(晨起 vs. 日间)分层,评估采样时间对检测性能的影响。结果 舌拭子检测总体敏感度为69.23%(45/65,95%CI: 57.28%~79.14%),特异性为94.17%(113/120,95%CI: 88.42%~97.16%),Kappa=0.66(95%CI: 0.55~0.78)。敏感性随菌载量降低而显著下降,高、中、低、极低菌量组敏感度分别为93.33%(14/15)、83.33%(15/18)、61.90%(13/21)、11.11%(1/9)。晨起取样亚组(24例)敏感度达100.00%(9/9),Kappa=0.91,但95%CI较宽(70.09%~100.00%)。结论 舌拭子PCR检测在疑似肺结核患者中特异性高、敏感性中等,检测效能受痰菌载量影响显著,可用于高菌载量患者及痰液获取困难者的辅助筛查; 低菌载量时阴性结果不能完全排除肺结核,需结合其他方法确认。晨起取样可能提升效能,但需大样本验证。

     

    Abstract: OBJECTIVE To evaluate the efficiency of tongue swab PCR testing in diagnosis of the patients with suspected pulmonary tuberculosis and observe the impact of sputum bacterial load and sampling time on the testing efficiency. METHODS Totally 185 patients with suspected pulmonary tuberculosis who were hospitalized in the tuberculosis department of The Fourth People's Hospital of Nanning from Sep. 2025 to Feb. 2026 were prospectively enrolled in the study. Set the sputum Xpert as the reference standard, the sensitivity, specificity and accurate rate of the tongue swab testing were calculated. 95%CI was calculated by Clopper-Pearson method, the consistency between the two methods was evaluated through Kappa consistency check. The subgroup analysis was performed based on the semiquantitative result of sputum Xpert (high, medium, low, and extremely low), and the impact of the bacterial load of sputum on the diagnostic efficiency was observed. The bacterial load of sputum specimens was stratified according to the sampling time (morning vs. daytime), and the impact of the sampling time on the detection performance was evaluated. RESULTS The overall sensitivity of the tongue swab testing was 69.23%(45/65,95%CI: 57.28% to 79.14%), with the specificity 94.17%(113/120,95%CI: 88.42% to 97.16%),Kappa=0.66(95%CI: 0.55 to 0.78). The sensitivity declined remarkably with the decrease of bacterial load, with the sensitivity 93.33%(14/15) in the high bacterial load group, 83.33%(15/18)in the medium bacterial load group, 61.90%(13/21) in the low bacterial load group, 11.11%(1/9) in the extremely low bacterial load group. The sensitivity reached up to 100.00% (9/9) in the morning sampling subgroup (24 cases), with Kappa=0.91,however, the 95%CI was broad (70.09% to 100.00%). CONCLUSIONS The tongue swab PCR testing exhibits high specificity and moderate sensitivity for the patients with suspected pulmonary tuberculosis. The testing efficiency is remarkably affected by the bacterial load of sputum. It can be used for the supported screening of the patients with high bacterial load and the patients who are difficult to obtain the sputum. The pulmonary tuberculosis can not be excluded completely by the negative result when it is low bacterial load, it is necessary to confirm with other methods. The morning sampling may raise the diagnostic efficiency, but it requires a large size of samples for validation.

     

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