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基层实验室中肺结核检测技术的诊断效能评估：环介导等温扩增技术与常规方法的有效性比较

Evaluation of efficacy of loop-mediated isothermal amplification and routine detections in diagnosis of pulmonary tuberculosis in laboratories at primary level

    摘要
  • 摘要:
    目的 探讨环介导等温扩增（LAMP）技术、利福平耐药实时荧光定量核酸扩增检测技术（GeneXpert MTB/RIF）、萋尼氏抗酸染色镜检及固体罗氏培养在基层实验室对肺结核的诊断效能。
    方法 纳入2023－2024年北京市朝阳区结核病门诊部初诊疑似肺结核患者171例作为研究对象，收集痰标本，对患者同一份痰标本同时进行LAMP、GeneXpert MTB/RIF、抗酸染色镜检及固体罗氏培养检测，分析并比较其阳性检出效率。以临床诊断结果为参考标准，评价各种检测方法的诊断效能。
    结果  研究对象经临床判定肺结核患者123例（确诊病例97例，临床诊断病例26例），非肺结核患者48例（非结核分枝杆菌病3例，肺炎45例）。GeneXpert MTB/RIF、LAMP、固体罗氏培养及抗酸染色镜检检测肺结核的阳性率分别为54.97%、40.35%、42.69%及26.90% ，差异具有统计学意义（χ2=57.673， P<0.001）。LAMP与GeneXpert MTB/RIF及抗酸染色镜检差异均有统计学意义（χ2=18.938， P<0.001; χ2=13.564， P<0.001），与固体罗氏培养的差异无统计学意义（χ2=0.471， P=0.493）。以临床诊断为参考，GeneXpert MTB/RIF、固体罗氏培养、LAMP及抗酸染色的灵敏度和特异度分别为：76.42%、100.00%； 56.91%、93.75%；55.28%、97.92%；36.59%、97.92%。4种方法一致率及Kappa值分别为:84.69%、0.65；73.12%、0.51；74.46%、0.53；67.49%、0.23。LAMP在GeneXpert MTB/RIF检测中阳、高阳判定时阳性结果一致，在低阳、极低阳、阴性结果中检出率分别为72.00%（18/25）、40.54%（15/37）、10.34%（3/29）。
    结论 LAMP方法检测肺结核效能与固体罗氏培养相当、优于传统抗酸染色，可以作为GeneXpert MTB/RIF的补充分子生物学检测途径，丰富基层实验室肺结核的检测手段。

     

    Abstract:
    Objective To evaluate the efficacy of loop-mediated isothermal amplification (LAMP), rifampicin-resistant real-time fluorescence quantitative nucleic acid amplification detection (GeneXpert MTB/RIF), acid-fast staining microscopy, and Roche solid culture in the diagnosis of pulmonary tuberculosis (TB).
    Methods A total of 171 suspected pulmonary TB patients in the tuberculosis outpatient department in Chaoyang district, Beijing from 2023 to 2024, were included in this study. Sputum samples were collected from them, and the same sputum sample from each patient was simultaneously tested by using LAMP, GeneXpert MTB/RIF, acid-fast staining microscopy, and Roche solid culture. The positive detection efficiency was analyzed and compared; the diagnostic efficacy of the detection methods was evaluated based on the clinical diagnosis results as the reference standard.
    Results In 123 clinically diagnosed cases of pulmonary TB, 97 were confirmed, and in 48 cases of non-pulmonary TB, 3 were infections of Mycobacteria other than tuberculosis and 45 were diagnosed with pneumonia. The positive rates of pulmonary TB diagnosed by GeneXpert MTB/RIF, LAMP, solid Roche culture and acid-resistant staining microscopy were 54.97%, 40.35%, 42.69% and 26.90% respectively, and the differences were significant (χ2=57.673, P<0.001). The comparison of LAMP with other three routine detections revealed that there were significant differences in positive rate between LAMP and GeneXpert MTB/RIF as well as acid-resistant staining microscopy （χ2=18.938, P<0.001; χ2=13.564, P<0.001）, while there was no significant difference in positive rate between LAMP and solid Roche culture（χ2=0.471, P=0.493）. Taking clinical diagnosis as a reference, the sensitivity and specificity were 76.42% and 100.00% for GeneXpert MTB/RIF, 56.91% and 93.75% for solid Roche culture, 55.28% and 97.92% for LAMP and 36.59% and 97.92% for acid-resistant staining. The consistency rate and Kappa value were 84.69% and 0.65 for GeneXpert MTB/RIF, 73.12% and 0.51 for solid Roche culture, 74.46% and 0.53 for LAMP, and 67.49% and 0.23 for acid-resistant staining .The results of LAMP were consistent were consistent GeneXpert MTB/RIF in the moderate positive and highly positive detections. The detection rates of LAMP in low positive, extremely low positive and negative results were 72.00% (18/25), 40.54% (15/37) and 10.34% (3/29), respectively.
    Conclusion The efficacy of LAMPin the detection of pulmonary TB is similar to the solid culture of Roche and superior to the traditional acid-fast staining, whichcan be used as a supplementary molecular biological detection for GeneXpert MTB/RIF to improve the detection of pulmonary TB in laboratories at primary level.

     

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