GeneXpert MTB/RIF检测技术在结核性胸膜炎诊断中的应用价值

目的评价GeneXpert MTB/RIF(简称"GeneXpert")检测技术对结核性胸膜炎诊断的应用价值。方法选取2017年1-12月辽宁省鞍山市结核病医院内科病房初诊疑似结核性胸膜炎患者180例。所有患者均在超声引导下行胸腔穿刺留取胸腔积液并立即送检,胸腔积液分别行抗酸染色涂片法检查(简称"涂片法")、BACTEC MGIT 960液体培养法(简称"MGIT 960培养")和GeneXpert检测。以临床确定诊断为参考标准,评价涂片法、MGIT 960培养和GeneXpert检测胸腔积液标本中结核分枝杆菌(MTB)的敏感度、特异度、阳性预测值、阴性预测值和一致率。结果在180例疑似结核性胸膜炎患者中,162例(90.00%)患者临床确诊为结核性胸膜炎,18例(10.00%)患者最终排除结核性胸膜炎。162例临床确诊患者中,61例(37.65%)MGIT 960培养阳性;101例(62.35%)根据临床表现、胸腔积液的生化指标、胸部影像和抗结核治疗有效等临床诊断为结核性胸膜炎。18例非结核性胸膜炎患者包括肺癌胸膜转移9例,结节病1例,系统性红斑狼疮性胸膜炎1例,胸膜间皮瘤2例,肾病综合征2例,心功能不全2例和低蛋白血症1例。以临床确诊结果为参考标准,涂片法、MGIT 960培养和GeneXpert检测的敏感度分别为0.00%(0/162)、37.65%(61/162)、54.94%(89/162);特异度均为100.00%(0/18);阳性预测值分别为0.00%(0/0)、100.00%(61/61)、100.00%(89/89);阴性预测值分别为10.00%(18/180)、15.13%(18/119)、19.78%(18/91);一致率分别为10.00%(18/180)、43.89%(79/180)、59.44%(107/180)。GeneXpert检测的敏感度明显高于涂片法和MGIT 960培养,差异有统计学意义(X~2=119.82,P=0.000)。结论 GeneXpert检测技术在结核性胸膜炎的诊断中具有较高的临床应用价值。

Assessment of GeneXpert MTB/RIF test for diagnosis of tuberculous pleurisy

Objective To evaluate the diagnostic performance of GeneXpert MTB/RIF (“Xpert”) for tuberculous pleurisy.Methods Pleural effusion samples collected with ultrasound guidance from 180 patients with suspected tuberculous pleurisy from Anshan Tuberculosis Hospital between January 2017 and December 2017 were tested with smear acid-fast bacilli testing (“smear”), liquid culture by BACTEC MGIT 960(“MGIT 960”) and GeneXpert. With clinical diagnosis results as the reference standard, sensitivity, specificity, positive prediction value, negative prediction value and consistent rate were evaluated for performances of smear test, MGIT 960 and GeneXpert test on detecting Mycobacterium tuberculosis (MTB) in those pleural effusion samples.Results Among those 180 suspected patients, 162 cases (90.00%) were confirmed as tuberculous pleurisy (TBP), 18 cases (10.00%) were excluded of TBP. Among the 162 cases of TBP, 61 cases (37.65%) were MGIT 960 culture-positive, 101 cases (62.35%) were diagnosed as TBP basing on standard clinical diagnosis criteria, including clinical symptoms, biochemical indicators of pleural effusion samples, results of chest imaging examination, and diagnostic anti-TB treatment results. Eighteen cases excluded of TBP had lung cancer pleural metastasis in 9 cases, sarcoidosis in 1 case, systematic lupus pleurisy in 1 case, pleural mesothelioma in 2 cases, nephropathy in 2 cases, cardiac insufficiency in 2 cases and hypoproteinemia in 1 case. With clinical diagnosis as the reference standard, the sensitivity of smear test, MGIT 960 and GeneXpert test were 0.00% (0/162), 37.65% (61/162) and 54.94% (89/162) separately; The specificity of three tests were all 100.00% (18/18); Positive prediction value of three tests were 0.00% (0/0),100.00% (61/61) and 100.00% (89/89); Negative prediction value of three tests were 10.00% (18/180),15.13% (18/119) and 19.78% (18/91);Consistent rate of three tests with clinical diagnosis results were 10.00% (18/180), 43.89% (79/180) and 59.44% (107/180) separately. Sensitivity of GeneXpert test was significantly higher than that of the smear and MGIT 960 culture (χ ²=119.82,P=0.000). Conclusion GeneXpert has high diagnostive value in detecting tuberculous pleurisy.