Xpert MTB/RIF对初治涂阴肺结核支气管肺泡灌洗液检测的研究
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摘要
目的探讨Xpert MTB/RIF检测支气管肺泡灌洗液对初治涂阴肺结核的早期快速诊断价值。方法对南通市第六人民医院2015年6月—2018年1月连续三次痰涂片阴性的疑似初治肺结核住院患者332例,在抗结核治疗前行支气管镜检查,收集支气管肺泡灌洗液(Bronchoalveolar lavage fluid,BALF),行结核分枝杆菌涂片、BACTEC MGIT960快速培养及Xpert MTB/RIF检测,比较三种方法的阳性率,并分别以培养阳性及临床诊断为标准,计算Xpert MTB/RIF诊断涂阴肺结核的敏感度、特异度、阳性预测值、阴性预测值。结果共有279例初治涂阴肺结核和53例非肺结核患者入组,279例初治涂阴肺结核的BALF检测结核分枝杆菌涂片、BACTEC MGIT960快速培养及Xpert MTB/RIF阳性率分别为2.51%、25.81%及50.90%,Xpert MTB/RIF阳性率明显高于涂片法及培养法,差异有统计学意义。以MGIT960培养阳性为标准,Xpert MTB/RIF诊断初治涂阴肺结核的敏感度为98.61%(71/72),特异度为100%(53/53);阳性预测值为100.00%(71/71),阴性预测值98.15%(53/54)。以临床诊断为标准,Xpert MTB/RIF诊断初治涂阴肺结核的敏感度为50.9%(142/279),特异度为100%(53/53)。阳性预测值为100%(142/142),阴性预测值27.89%(53/190)。以DST结果为金标准,Xpert MTB/RIF检测利福平耐药的敏感度、特异度分别为87.5%,98.44%,Xpert MTB/RIF与DST两种方法检测利福平耐药的一致率达到97.22%。且检测完成时间仅需2 h。结论 BALF中Xpert MTB/RIF检测敏感度、特异度均较高且能判断是否对利福平耐药,对初治涂阴肺结核有较大的早期快速诊断价值。
Objective To investigate the value of Xpert MTB/RIF in detecting bronchoalveolar lavage fluid(BALF) in the early diagnosis of the initial treatment of smear negative pulmonary tuberculosis. Methods From June 2015 to January 2018, 332 patients with suspected the initial treatment of pulmonary tuberculosis admitted in Sixth People's Hospital of Nantong City were enrolled in the clinical study of three consecutive times with negative sputum smear, and bronchoscopy was performed before anti-tuberculosis treatment. Bronchoalveolar lavage fluid(BALF) was collected, for Mycobacterium tuberculosis smear, BACTEC MGIT960 rapid culture and Xpert MTB/RIF detection. The positive rates of the three methods were compared. The sensitivity, specificity, positive predictive value and negative predictive value of Xpert MTB/RIF in the diagnosis of smear negative the initial treatment of tuberculosis were calculated. Results A total of 279 cases of the initial treatment smear negative pulmonary tuberculosis and 53 cases of non-pulmonary tuberculosis were enrolled in the study. The positive rates of Mycobacterium tuberculosis smear, BACTEC MGIT960 rapid culture and Xpert MTB/RIF were 2.51%, 25.81%and 50.90%,the positive rate of Xpert MTB/RIF was significantly higher than that in smear and culture. Taking MGIT960 culture positive results as reference standard, the sensitivity, specificity, positive predictive value, negative predictive value of Xpert MTB/RIF for the initial treatment smear-negative PTB testing BALF were 98.61%(71/72),100%(53/53), 100%(71/71), 98.15%(53/54). Taking clinical diagnostic criteria as reference standard, the sensitivity,specificity,positive predictive value,negative predictive value of Xpert MTB/RIF for the initial treatment smear-negative PTB testing BALF were 50.9%(142/279), 100%(53/53), 100%(142/142), 27.89%(53/190). With DST results as the gold standard, the sensitivity and specificity of rifampicin resistance using Xpert MTB/RIF were 87.5%, 98.44% respectively, and the consistent rate of rifampin resistance detected by Xpert MTB/RIF and DST reached 97.22%. And the detection time was only 2 hours.Conclusion The sensitivity and specificity of Xpert MTB/RIF detection in BALF are relatively high, and it can determine whether it is resistant to rifampicin or not. The detection time is short, which is of great early and rapid diagnostic value for the initial treatment of smear negative pulmonary tuberculosis and is worthy of clinical promotion.
Objective To investigate the value of Xpert MTB/RIF in detecting bronchoalveolar lavage fluid(BALF) in the early diagnosis of the initial treatment of smear negative pulmonary tuberculosis. Methods From June 2015 to January 2018, 332 patients with suspected the initial treatment of pulmonary tuberculosis admitted in Sixth People's Hospital of Nantong City were enrolled in the clinical study of three consecutive times with negative sputum smear, and bronchoscopy was performed before anti-tuberculosis treatment. Bronchoalveolar lavage fluid(BALF) was collected, for Mycobacterium tuberculosis smear, BACTEC MGIT960 rapid culture and Xpert MTB/RIF detection. The positive rates of the three methods were compared. The sensitivity, specificity, positive predictive value and negative predictive value of Xpert MTB/RIF in the diagnosis of smear negative the initial treatment of tuberculosis were calculated. Results A total of 279 cases of the initial treatment smear negative pulmonary tuberculosis and 53 cases of non-pulmonary tuberculosis were enrolled in the study. The positive rates of Mycobacterium tuberculosis smear, BACTEC MGIT960 rapid culture and Xpert MTB/RIF were 2.51%, 25.81%and 50.90%,the positive rate of Xpert MTB/RIF was significantly higher than that in smear and culture. Taking MGIT960 culture positive results as reference standard, the sensitivity, specificity, positive predictive value, negative predictive value of Xpert MTB/RIF for the initial treatment smear-negative PTB testing BALF were 98.61%(71/72),100%(53/53), 100%(71/71), 98.15%(53/54). Taking clinical diagnostic criteria as reference standard, the sensitivity,specificity,positive predictive value,negative predictive value of Xpert MTB/RIF for the initial treatment smear-negative PTB testing BALF were 50.9%(142/279), 100%(53/53), 100%(142/142), 27.89%(53/190). With DST results as the gold standard, the sensitivity and specificity of rifampicin resistance using Xpert MTB/RIF were 87.5%, 98.44% respectively, and the consistent rate of rifampin resistance detected by Xpert MTB/RIF and DST reached 97.22%. And the detection time was only 2 hours.Conclusion The sensitivity and specificity of Xpert MTB/RIF detection in BALF are relatively high, and it can determine whether it is resistant to rifampicin or not. The detection time is short, which is of great early and rapid diagnostic value for the initial treatment of smear negative pulmonary tuberculosis and is worthy of clinical promotion.
引文
[1]中华医学会结核病学分会.肺结核诊断和治疗指南[J].中华结核和呼吸杂志, 2001, 24(2):70-74.
[2]郑惠聪,陈益彪.涂阴肺结核的诊断与治疗[J].临床肺科杂志,2012,17(5):941-942.
[3] GFIRSOY N C, YAKUPOGULLAR Y, TEKEREKOGLU M S, et a1.E-valuation of the diagnostic performance of Xpert MTB/RIF test for the detection of Mycobacterium tuberculosis and rifampin resistance in clinical samples[J]. Mikrobiyol Bul,2016, 50(2):196-204.
[4]张国钦,巨韩芳,钟达,等. XpertMTB/RIF应用于可疑肺结核患者诊断效果分析[J].中国热带医学, 2017, 17(3):266-269.
[5]刘佳庆,张丽霞,秦中华,等. XpertMTB/RIF和T.SPOT.TB对涂阴肺结核诊断价值的评估[J].临床检验杂志, 2016, 34(10):755-757.
[6]中华人民共和国国家卫生和计划生育委员会.肺结核诊断:WS288—2017[S].北京:中国标准出版社, 2017:3-4.
[7]尹青琴,申阿东. Xpert MTB/RIF试验在结核病诊断中的研究现状[J].中华结核和呼吸杂志, 2012, 35(5):363-365.
[8]张贺秋,赵雁林.现代结核病诊断技术[M].北京:人民卫生出版社, 2013:47-66.
[9]宋华峰,赵静,胥萍.荧光定量PCR在结核分枝杆菌快速诊断中的研究[J].中国热带医学, 2018,,18(7):,687-690.
[10]杨振兴,陈威,许敏,等.五种检测方法在结核病诊断中的应用评价[J].中国热带医学, 2016, 16(10):1024-1026.
[11] BLAKEMORE R, STORY E, HELB D, et al. Evaluation of the analytical performance of the Xpert MTB/RIF assay[J]. J Clin Microbiol,2010, 48(7):2495-2501.
[12]梁佳元,杨立军,刘敏,等. Hain和Xpert MTB/RIF技术对结核分枝杆菌药物敏感性的检测[J].中国热带医学, 2017, 17(3):263-265.
[13] FRIEDRICH S O, R ACHOW A, SAATHOFF E, et a1. Assessm ent of the sensitivity and specificity of Xpert MTB/R IF assay as an early sputum biomarker of response to tuberculosis treatment[J].Lancet Respir Med, 2013, 1(6):462-470.
[14] RAMASWAMY S, MUSSER J M, Molecular genetic basis of antimicrobialagent resistance in Mycobacterium tuberculosis:1998 update[J]. Tuber Lung Dis, 1998, 79(1):3-29.
[2]郑惠聪,陈益彪.涂阴肺结核的诊断与治疗[J].临床肺科杂志,2012,17(5):941-942.
[3] GFIRSOY N C, YAKUPOGULLAR Y, TEKEREKOGLU M S, et a1.E-valuation of the diagnostic performance of Xpert MTB/RIF test for the detection of Mycobacterium tuberculosis and rifampin resistance in clinical samples[J]. Mikrobiyol Bul,2016, 50(2):196-204.
[4]张国钦,巨韩芳,钟达,等. XpertMTB/RIF应用于可疑肺结核患者诊断效果分析[J].中国热带医学, 2017, 17(3):266-269.
[5]刘佳庆,张丽霞,秦中华,等. XpertMTB/RIF和T.SPOT.TB对涂阴肺结核诊断价值的评估[J].临床检验杂志, 2016, 34(10):755-757.
[6]中华人民共和国国家卫生和计划生育委员会.肺结核诊断:WS288—2017[S].北京:中国标准出版社, 2017:3-4.
[7]尹青琴,申阿东. Xpert MTB/RIF试验在结核病诊断中的研究现状[J].中华结核和呼吸杂志, 2012, 35(5):363-365.
[8]张贺秋,赵雁林.现代结核病诊断技术[M].北京:人民卫生出版社, 2013:47-66.
[9]宋华峰,赵静,胥萍.荧光定量PCR在结核分枝杆菌快速诊断中的研究[J].中国热带医学, 2018,,18(7):,687-690.
[10]杨振兴,陈威,许敏,等.五种检测方法在结核病诊断中的应用评价[J].中国热带医学, 2016, 16(10):1024-1026.
[11] BLAKEMORE R, STORY E, HELB D, et al. Evaluation of the analytical performance of the Xpert MTB/RIF assay[J]. J Clin Microbiol,2010, 48(7):2495-2501.
[12]梁佳元,杨立军,刘敏,等. Hain和Xpert MTB/RIF技术对结核分枝杆菌药物敏感性的检测[J].中国热带医学, 2017, 17(3):263-265.
[13] FRIEDRICH S O, R ACHOW A, SAATHOFF E, et a1. Assessm ent of the sensitivity and specificity of Xpert MTB/R IF assay as an early sputum biomarker of response to tuberculosis treatment[J].Lancet Respir Med, 2013, 1(6):462-470.
[14] RAMASWAMY S, MUSSER J M, Molecular genetic basis of antimicrobialagent resistance in Mycobacterium tuberculosis:1998 update[J]. Tuber Lung Dis, 1998, 79(1):3-29.