Reechaipichitkul Wipa, Suleesathira Tanapong, Chaimanee Prajaub
Southeast Asian J Trop Med Public Health. 2017 Mar;48(2):313-21.
Among infectious agents, Mycobacterium tuberculosis remains one of the most significant causes of death worldwide. Rapid and accurate diagnosis of pulmonary tuberculosis (TB) remains a great challenge. GeneXpert MTB/RIF assay is a novel integrated diagnostic system for rapid diagnosis of TB and particularly of rifampicin-resistant strains. A study was conducted between January 2010 and December 2014 to compare the performance of the sputum GeneXpert MTB/RIF assay with the conventional sputum AFB smear for diagnosis of active pulmonary TB in Thailand, a country with a high burden of this disease. Of the 125 patients who had cough and/or prolonged fever together with abnormal chest radiograph, 63 were diagnosed as having pulmonary TB by mycobacterium culture assay, while the remaining subjects were considered of having TB-like conditions, viz non-tuberculous mycobacterium infection (NTM), bacterial pneumonia or bronchogenic carcinoma. Two-thirds of the patients had underlying diseases, eg, diabetes mellitus (19 patients), autoimmune diseases (14), and HIV (6). Among patients with positive diagnosis of M. tuberculosis infection, 30 were AFB smear positive and 53 by sputum GeneXpert MTB/RIF method; among patients negative for M. tuberculosis infection, 4 were AFB smear positive and 5 by GeneXpert MTB/ RIF assay. Sensitivity and specificity of the sputum AFB smear and GeneXpertMTB/ RIF assay test were 48% (95% CI: 35-61) and 84% (95% CI: 73-92), and 94% (95% CI: 84-98) and 92% (95% CI: 82-97), respectively. Diagnostic performance of the GeneXpert MTB/RIF assay among AFB smear positive patients was higher than among AFB smear negative patients (adjusted OR 6.7; 95% CI: 2.3-19.9). Earlier diagnosis of pulmonary TB using GeneXpert MTB/RIF assay will lead to earlier appropriate treatment and provide opportunities to interrupt TB transmission.
在感染性病原体中，结核分枝杆菌仍是全球最重要的致死原因之一。肺结核（TB）的快速准确诊断仍然是一项巨大挑战。GeneXpert MTB/RIF检测是一种用于快速诊断结核病尤其是耐利福平菌株的新型综合诊断系统。在2010年1月至2014年12月期间开展了一项研究，以比较痰GeneXpert MTB/RIF检测与传统痰抗酸杆菌涂片在泰国（该国结核病负担沉重）诊断活动性肺结核方面的性能。在125例有咳嗽和/或长期发热且胸部X线片异常的患者中，63例通过分枝杆菌培养检测被诊断为患有肺结核，而其余受试者被认为患有类结核病症，即非结核分枝杆菌感染（NTM）、细菌性肺炎或支气管源性癌。三分之二的患者有基础疾病，如糖尿病（19例患者）、自身免疫性疾病（14例）和艾滋病毒（6例）。在结核分枝杆菌感染诊断为阳性的患者中，30例抗酸杆菌涂片呈阳性，53例通过痰GeneXpert MTB/RIF方法呈阳性；在结核分枝杆菌感染诊断为阴性的患者中，4例抗酸杆菌涂片呈阳性，5例通过GeneXpert MTB/RIF检测呈阳性。痰抗酸杆菌涂片和GeneXpert MTB/RIF检测的敏感性和特异性分别为48%（95%CI：35 - 61）和84%（95%CI：73 - 92），以及94%（95%CI：84 - 98）和92%（95%CI：82 - 97）。在抗酸杆菌涂片阳性患者中，GeneXpert MTB/RIF检测的诊断性能高于抗酸杆菌涂片阴性患者（校正OR 6.7；95%CI：2.3 - 19.9）。使用GeneXpert MTB/RIF检测更早诊断肺结核将导致更早进行适当治疗，并为阻断结核病传播提供机会。
