目的: 应用核酸飞行时间质谱技术（简称“核酸质谱”）对结核分枝杆菌（TB）与非结核分枝杆菌（NTM）的菌种鉴定及耐药检测的临床价值。方法: 前瞻性纳入2020年3月—2022年5月我院收治的胸部感染性疾病（排除病毒和真菌感染）患者共199例,提取痰液或者支气管肺泡灌洗液分别进行抗酸染色、菌落培养和药物试验以及核酸质谱分析,比较诊断性能。结果: 根据临床症状、影像学表现、菌落培养以及PCR结果进行综合判断,最终确诊TB阳性113例,NTM阳性51例和TB、NTM均阴性35例。核酸质谱共检出TB阳性130例,NTM阳性59例和均阴性10例。核酸质谱检出TB阳性准确率为88.4%[（110+66）/199],敏感度为97.3%（110/113）,特异度为76.7%（66/86）,阳性预测值为84.6%（110/130）,阴性预测值为95.7%（66/69）。检出NTM阳性准确率为92.0%[（47+136）/199],敏感度为92.2%（47/51）,特异度为91.9%（136/148）,阳性预测值为79.7%（47/59）,阴性预测值为97.1%（136/140）。与其他两种检测方法相比,核酸质谱失败率显著降低,TB阳性与NTM阳性的准确率、敏感度、特异度、阳性预测值与阴性预测值显著升高,且检测时间显著缩短（P<0.05）。核酸质谱检出TB均为结核杆菌复合群,NTM有9种,TB耐药80例（70.8%,80/113）。结论: 核酸质谱作为快速鉴别TB和NTM感染的新型技术,有较高的准确率、敏感度和特异度,能够提供详细的菌种亚型和耐药谱信息,对指导临床制定恰当的药物干预方案,降低多重耐药菌的产生具有十分重要的意义。
Abstract
Objective To evaluate the clinical value of nucleic acid time-of-flight mass spectrometry for the identification of mycobacterium tuberculosis (TB) or non-tuberculosis (NTM) and drug resistance detection. Methods A total of 199 patients with thoracic infectious diseases (excluding viral and fungal infections) admitted to our hospital from March 2020 to May 2022 were prospectively included. Sputum or bronchoalveolar lavage fluid were extracted for acid fast staining, colony culture and drug test, and nucleic acid mass spectrometry analysis, respectively, then to compare the diagnostic performance. Results According to clinical symptoms, imaging findings, colony culture and PCR results, 113 cases were confirmed to be TB positive, 51 cases were NTM positive and 35 cases were both negative. A total of 130 TB positive, 59 NTM positive and 10 negative were detected by nucleic acid mass spectrometry. The positive accuracy rate of TB detection by nucleic acid mass spectrometry was 88.4% [ (110+66) /199], sensitivity was 97.3% (110/113), specificity was 76.7% (66/86), positive predictive value was 84.6% (110/130), and negative predictive value was 95.7% (66/69). The positive accuracy of NTM detection was 92.0% [ (47+136) /199], sensitivity was 92.2% (47/51), specificity was 91.9% (136/148), positive predictive value was 79.7% (47/59), and negative predictive value was 97.1% (136/140). Compared with the other two detection methods, the failure rate of nucleic acid mass spectrometry was significantly lower, accuracy, sensitivity, specificity, positive predictive value and negative predictive value of TB positive and NTM positive were significantly higher, and the detection time was significantly shorter (P<0.05). Nucleic acid mass spectrometry detected TB was mycobacterium tuberculosis complex, 9 kinds of NTM, 80 cases of TB resistance (70.8%, 80/113). Conclusion As a new technology for rapid identification of TB or NTM infection, nucleic acid mass spectrometry has a higher accuracy, sensitivity and specificity, which could provide detailed information of bacterial subtypes and drug resistance spectrum, and is of great significance in guiding clinical formulation of appropriate drug intervention programs and reducing the production of multi-drug resistant bacteria.
关键词
核酸飞行时间质谱技术 /
结核分枝杆菌 /
非结核分枝杆菌 /
耐药
Key words
nucleic acid time-of-flight mass spectrometry /
mycobacterium tuberculosis /
non-tuberculous mycobacterium /
drug resistance
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