State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, 310003, China.
Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, 310051, China.
Sci Rep. 2018 Jul 12;8(1):10587. doi: 10.1038/s41598-018-28955-0.
The objective of the present study was to conduct a multicentre, prospective evaluation of the diagnostic performance of the Biochip system for the detection of drug-resistant tuberculosis using smear-positive sputum specimens. This prospective study evaluated the diagnostic performance of this new platform for drug resistant and multidrug-resistant tuberculosis (MDR-TB) using 1491 smear-positive sputum specimens collected from multiple clinical settings. Using conventional culture-based culturing and drug-susceptibility testing as reference standards, the biochip system had a sensitivity of 86.08% and a specificity of 97.7% for rifampicin (RIF) detection, in detecting isoniazid (INH) resistance, it had a sensitivity of 79.36% and a specificity of 98.71%. With respect to MDR-TB detection, the sensitivity was 78.01% and the specificity was 98.86%. The performance only varies among different sites for RIF resistance, and there are no other statistically difference in diagnostic performance for other variables considered. The Biochip system shows favourable sensitivity and specificity for RIF and INH resistance, along with MDR-TB detection, directly using clinical smear-positive sputum samples. It is an alternative to conventional drug-susceptibility testing (DST) for detecting drug resistance or MDR-TB and is a method worth expanding to clinical settings in China.
本研究的目的是对 Biochip 系统检测涂阳标本中耐药结核病的诊断性能进行多中心前瞻性评估。这项前瞻性研究评估了该新平台在耐药和耐多药结核病（MDR-TB）方面的诊断性能，共使用来自多个临床环境的 1491 份涂阳痰标本。以传统的基于培养的培养和药敏试验作为参考标准，该生物芯片系统对利福平（RIF）检测的敏感性为 86.08%，特异性为 97.7%，对异烟肼（INH）耐药的敏感性为 79.36%，特异性为 98.71%。对于 MDR-TB 的检测，敏感性为 78.01%，特异性为 98.86%。性能仅在不同地点检测 RIF 耐药方面存在差异，对于其他考虑的变量，没有其他统计学差异的诊断性能。Biochip 系统直接使用临床涂阳痰标本，显示出有利福平（RIF）和异烟肼（INH）耐药以及 MDR-TB 检测的良好敏感性和特异性。它是检测耐药性或 MDR-TB 的替代传统药敏试验（DST）的方法，值得在中国的临床环境中推广。
