Mertaniasih Ni Made, Kusmiati Tutik, Koendhori Eko Budi, Kusumaningrum Deby, Sulistyowati Titiek, Nuha Zakiyathun, Chanifah Hatif
Department of Medical Microbiology, Faculty of Medicine, Universitas Airlangga, Surabaya 60131, Indonesia.
Laboratory of Tuberculosis, Institute of Tropical Disease, Universitas Airlangga, Surabaya 60115, Indonesia.
J Clin Tuberc Other Mycobact Dis. 2020 Mar 13;19:100159. doi: 10.1016/j.jctube.2020.100159. eCollection 2020 May.
Handling of PTB and EPTB patients with adequate standard detection of MTBC and anti-TB drug sensitivity using accurate and rapid methods could provide good TB management and clinical treatment outcomes. The Xpert MTB/RIF assay is an automated, cartridge-based NAAT that can simultaneously detect MTBC and RIF resistance within 2 h. The aim of this study was to evaluate the implementation of Xpert for determining diagnosis of PTB and EPTB in adults and children.
A descriptive study was performed using e-TB Manager data from the MDR-TB Clinic at Dr. Soetomo Academic Hospital. Suspected TB cases were from the areas of East Java Province from January 2016 to December 2018. Xpert assay was conducted using standardized criteria for clinically suspected TB, and MTBC-positive results with RR were examined by the culture method using MGIT 960 BACTEC System.
A total of 1181 (1181/3009, 39.25%) sputum samples from suspected new MDR-PTB cases tested positive for MTBC with 3.02% RR. Among 3893 sputum samples from previously treated probable MDR-PTB cases tested using Xpert, 1936 (49.73%) were MTBC positive with 13.20% RR. Among 59 new suspected MDR-PTB cases tested using MGIT 960 BACTEC System, 55 tested positive for MTBC, although all RR strains were highly sensitive to amikacin (100%), kanamycin (95%), and ofloxacin (89%). A total of 49 children with suspected PTB were tested using Xpert, revealing low positivity (12%) for MTBC, with all RR strains being rifampicin sensitive (RS). Of the 86 suspected EPTB cases tested using Xpert, very few were MTBC-positive (26%), with 91% RS.
This study revealed that in adults and children with PTB and EPTB, the Xpert assay achieved a low positivity detection rate for MTBC in samples from new or previously treated cases, and this could be the result of many factors.
采用准确、快速的方法对肺结核（PTB）和肺外结核（EPTB）患者进行处理，并对结核分枝杆菌复合群（MTBC）进行充分的标准检测及抗结核药物敏感性检测，可为结核病管理和临床治疗提供良好的结果。Xpert MTB/RIF检测是一种基于试剂盒的自动化核酸扩增检测技术（NAAT），可在2小时内同时检测MTBC和利福平耐药性。本研究的目的是评估Xpert在确定成人和儿童PTB和EPTB诊断中的应用情况。
利用苏托莫博士学术医院耐多药结核病诊所的电子结核病管理数据进行描述性研究。疑似结核病病例来自东爪哇省2016年1月至2018年12月的地区。采用临床疑似结核病的标准化标准进行Xpert检测，MTBC阳性且利福平耐药（RR）的结果通过使用MGIT 960 BACTEC系统的培养方法进行检测。
在1181例疑似新发耐多药肺结核病例的痰标本中，共有1181例（1181/3009，39.25%）MTBC检测呈阳性，RR率为3.02%。在3893例既往治疗过的可能耐多药肺结核病例的痰标本中，采用Xpert检测，1936例（49.73%）MTBC呈阳性，RR率为13.20%。在59例使用MGIT 960 BACTEC系统检测的新发疑似耐多药肺结核病例中，55例MTBC检测呈阳性，尽管所有RR菌株对阿米卡星（100%）、卡那霉素（95%）和氧氟沙星（89%）高度敏感。共有49例疑似肺结核儿童接受了Xpert检测，结果显示MTBC阳性率较低（12%），所有RR菌株对利福平敏感（RS）。在86例使用Xpert检测的疑似EPTB病例中，MTBC阳性的病例很少（26%）且91%为RS。
本研究表明，在患有PTB和EPTB的成人和儿童中，Xpert检测在新发或既往治疗病例的样本中对MTBC的阳性检出率较低，这可能是多种因素导致的结果。
