关键词: 分枝杆菌, 结核, 抗药性, 多种, 细菌, 寡核苷酸序列分析, 实验室, 医院, 评价研究

Abstract: Objective To evaluate the performance of genechip in detecting rifampicin resistant, isoniazid resistant and multidrug-resistant tuberculosis (MDR-TB), and to analyze the feasibility of genechip application in the prefectural-level TB laboratory. Methods The sputum samples collected from 745 smear positive TB patients detected in Lianyungang city from January 1st 2011 to March 31st 2012 were applied by both genechip and conventional drug susceptibility testing (DST). Out of 745 TB patients, 111 were excluded due to negative culture result and non-tuberculous Mycobacteria. The conventional DST results were served as the gold standard, the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were analyzed among 634 TB patients. Results The results showed that the sensitivity and specificity of genechip were 84.4% (65/77) and 97.7% (544/557) for rifampicin resistance, 80.9% (76/94) and 97.4% (526/540) for isoniazid resistance and 70.0% (42/60) and 98.3% (564/574) for MDR respectively. The costs of genechip and conventional DST for detecting one smear positive TB patient were 165.65 yuan and 374.07 yuan,respectively. Conclusion Genechip is a more effectient, rapid, safer and more cost-effective diagnosis tool for drug-resistant tuberculosis in Chinese primary laboratories.

Key words: Mycobacterium tuberculosis, Drug resistance, multiple, Oligonucleotide array sequence analysis, Laboratories, hospital, Evaluation studies