目的评价结核分枝杆菌环介导等温扩增技术（LAMP）快速检测试剂盒的临床应用效果。方法选取肺结核患者183例（肺结核组）和非肺结核患者120例（对照组）。采用涂片抗酸染色、罗氏培养法和LAMP对痰标本进行检测，采用结核分枝杆菌核酸扩增荧光检测试剂盒（TB- PCR）检测罗氏培养与LAMP结果不符的标本，分析LAMP与罗氏培养的检出率及两者的符合率。结果去除经鉴定为非结核分枝杆菌的10例标本，涂片抗酸染色、罗氏培养法和LAMP的阳性检出率分为64.1%（111/173）、64.7%（112/173）、78.6%（136/173）。LAMP与抗酸染色、罗氏培养阳性检出率的差异有统计学意义（P＜0.01）,抗酸染色与罗氏培养比较差异无统计学意义（P＞0.05）。以罗氏培养为金标准，LAMP检测的灵敏度、特异度、阳性预测值和阴性预测值分别为88.5%（108/122）、82.3%（149/181）、77.1%（108/140）、91.4%（149/163），LAMP检测与罗氏培养的符合率为84.8%（257/303）。结论结核分枝杆菌环介导等温扩增技术的灵敏度和特异度高，具有简单易行、快速准确的特点,在肺结核患者的早期诊断中将发挥重要作用。%Objective To assess the clinical use of the loop- mediated isothermal amplification(LAMP) assay for detection mycobacterium tuberculosis in sputum samples. Methods LAMP with acid- fast bacilli (AFB)smear microscopy and Lowen-stein- Jensen (L- J)culture, were performed in 183 sputum specimens from pulmonary tuberculosis patients and 120 sputum specimens from non- pulmonary tuberculosis patients. The samples with different results between LAMP and L- J culture were tested by mycobacterium tuberculosis PCR fluorescence diagnostic kits. L- J culture positive strains were identified by p- Ni-trobenzoic acid medium. The sensitivity and specificity of LAMP were calculated according to the result of L- J culture. The de-tection rates of the 3 methods were analyzed according to the clinical diagnosis and the differences were analyzed by chi- square test. Results For tuberculosis patient (removing 10 samples caused by NTM),the detection rate of AFB, L- J culture and LAMP were 64.1%(111/173)、64.7%(112/173)、78.6%(136/173), respectively. The differences between LAMP and other 2 methods were signifinant(P<0.01). The difference between the detection rates of AFB and L- J culture was not significant(P>0.05). With the results of L- J culture as the reference ,the sensitivity、specificity、positive and negative predictive values of LAMP were 88.5%(108/122)、82.3%(149/181)、77.1%(108/140)、91.4%(149/163),respectively. The accordance rate of LAMP and L- J culture was 84.8%(257/303). Conclusion LAMP is a rapid,sensitive and specific method for detection of mycobacterium tuberculosis in clinical sputum samples.
展开▼
