Infectious Diseases and Clinical Microbiology Department, Faculty of Medicine, Ege University, Izmir, Turkey.
J Clin Microbiol. 2011 Dec;49(12):4138-41. doi: 10.1128/JCM.05434-11. Epub 2011 Sep 28.
Mycobacterium tuberculosis remains one of the most significant causes of death from an infectious agent. The rapid diagnosis of tuberculosis and detection of rifampin (RIF) resistance are essential for early disease management. The GeneXpert MTB/RIF assay is a novel integrated diagnostic device for the diagnosis of tuberculosis and rapid detection of RIF resistance in clinical specimens. We determined the performance of the MTB/RIF assay for rapid diagnosis of tuberculosis and detection of rifampin resistance in smear-positive and smear-negative pulmonary and extrapulmonary specimens obtained from possible tuberculosis patients. Two hundred fifty-three pulmonary and 176 extrapulmonary specimens obtained from 429 patients were included in the study. One hundred ten (89 culture positive and 21 culture negative for M. tuberculosis) of the 429 patients were considered to have tuberculosis. In pulmonary specimens, sensitivities were 100% (27/27) and 68.6% (24/35) for smear-positive and smear-negative specimens, respectively. It had a lower sensitivity with extrapulmonary specimens: 100% for smear-positive specimens (4/4) and 47.7% for smear-negative specimens (21/44). The test accurately detected the absence of tuberculosis in all 319 patients without tuberculosis studied. The MTB/RIF assay also detected 1 RIF-resistant specimen and 88 RIF-susceptible specimens, and the results were confirmed by drug susceptibility testing. We concluded that the MTB/RIF test is a simple method, and routine staff with minimal training can use the system. The test appeared to be as sensitive as culture with smear-positive specimens but less sensitive with smear-negative pulmonary and extrapulmonary specimens that include low numbers of bacilli.
结核分枝杆菌仍然是由感染性病原体引起的死亡的主要原因之一。结核病的快速诊断和利福平（RIF）耐药性的检测对于早期疾病管理至关重要。GeneXpert MTB/RIF 检测是一种用于诊断结核病和快速检测临床标本中利福平耐药性的新型综合诊断设备。我们确定了 MTB/RIF 检测在快速诊断结核病和检测涂阳和涂阴肺和肺外标本中的利福平耐药性的性能，这些标本来自可能患有结核病的患者。研究纳入了 429 例患者的 253 份肺标本和 176 份肺外标本。在这 429 例患者中，有 110 例（89 例培养阳性和 21 例培养阴性的结核分枝杆菌）被认为患有结核病。在肺标本中，敏感性分别为 100%（27/27）和 68.6%（24/35），对于涂阳和涂阴标本。用肺外标本的敏感性较低：涂阳标本 100%（4/4）和涂阴标本 47.7%（21/44）。该检测准确地检测到所有 319 例未患结核病的患者中均无结核病。MTB/RIF 检测还检测到 1 份 RIF 耐药标本和 88 份 RIF 敏感标本，结果通过药敏试验得到证实。我们得出结论，MTB/RIF 检测是一种简单的方法，经过最少培训的常规工作人员可以使用该系统。该检测与涂阳标本的培养一样敏感，但对包括少量细菌的涂阴肺和肺外标本的敏感性较低。
