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A feasibility study of the Xpert MTB/RIF test at the peripheral level laboratory in China

机译：在中国外围实验室进行Xpert MTB / RIF测试的可行性研究

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Objective: To evaluate the performance of Xpert MTB/RIF (MTB/RIF) in the county-level tuberculosis (TB) laboratory in China. Methods: From April 2011 to January 2012, patients with suspected multidrug-resistant tuberculosis (MDR-TB) and non-MDR-TB were enrolled consecutively from four county-level TB laboratories. The detection of Mycobacterium tuberculosis (MTB) by MTB/RIF was compared to detection by Lowenstein-Jensen culture. The detection of rifampin resistance was compared to detection by conventional drug-susceptibility testing. The impact of multiple specimens on the performance of MTB/RIF was also evaluated. Results: A total of 2142 suspected non-MDR-TB cases and 312 suspected MDR-TB cases were enrolled. For MTB detection in suspected non-MDR-TB cases, the sensitivity and specificity of MTB/RIF were 94.4% and 90.2%, respectively. The sensitivity in smear-negative patients was 88.8%. For the detection of rifampin resistance in suspected non-MDR-TB cases, the sensitivity and specificity of MTB/RIF were 87.1% and 97.9%, respectively. For the detection of rifampin resistance in suspected MDR-TB cases, the sensitivity and specificity of MTB/RIF were 87.1% and 91.0%, respectively. Using multiple sputum specimens had no significant influence on the performance of MTB/RIF for MTB detection. Conclusions: The introduction of MTB/RIF could increase the accuracy of detection of MTB and rifampin resistance in peripheral-level TB laboratories in China. One single specimen is adequate for TB diagnosis by MTB/RIF.
机译：目的：评估Xpert MTB / RIF（MTB / RIF）在中国县级结核病（TB）实验室中的表现。方法：从2011年4月至2012年1月，连续从四个县级结核病实验室招募疑似耐多药结核病（MDR-TB）和非MDR-TB的患者。将MTB / RIF检测到的结核分枝杆菌（MTB）与Lowenstein-Jensen培养检测到的结核菌进行了比较。将利福平抗性的检测与通过常规药物敏感性测试的检测进行了比较。还评估了多个样本对MTB / RIF性能的影响。结果：共纳入2142例疑似非耐多药结核病病例和312例疑似耐多药结核病病例。对于疑似非耐多药结核病病例的MTB检测，MTB / RIF的敏感性和特异性分别为94.4％和90.2％。涂片阴性患者的敏感性为88.8％。为了检测疑似非耐多药结核病病例的利福平耐药性，MTB / RIF的敏感性和特异性分别为87.1％和97.9％。为了检测疑似耐多药结核病患者的利福平耐药性，MTB / RIF的敏感性和特异性分别为87.1％和91.0％。使用多个痰标本对MTB / RIF检测MTB的性能没有明显影响。结论：MTB / RIF的引入可以提高中国外周结核病实验室MTB检测和利福平耐药性的准确性。一个单独的样本就足以通过MTB / RIF诊断结核病。

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