title: Evaluation of biochip system in determining isoniazid and rifampicin resistances of mycobacterium tuberculosis in sputum samples.
abstract: OBJECTIVE
  To evaluate a biochip system in determining isoniazid and rifampicin resistances of Mycobacterium tuberculosis in sputum samples in a Chinese population.
  
  
  METHODS
  We assembled 907 sputum smeared positive specimens of tuberculosis patients in total. Each sample would be separated into two parts for culture and biochip assay simultaneously. And those cultured positive and having full drug resistance results would be used as reference. The McNemar χ² test was adopted for evaluating the paired 2×2 table.
  
  
  RESULTS
  Compared with drug sensitivity test, the agreement rates of the two methods in detecting rifampicin and isoniazid resistances were 93.37% and 94.49%, respectively. The sensitivity and specificity of biochip in detecting isoniazid were 74.31% and 96.92%, respectively. Meanwhile, the sensitivity and specificity for rifampicin were 79.76% and 96.53%, respectively. For multi-drug resistance, the sensitivity and specificity were 64.62% and 97.75%, respectively.
  
  
  CONCLUSIONS
  The biochip system is a rapid and accurate method for drug resistant tuberculosis diagnosis using sputum samples directly, especially for rifampicin resistance detection.
authors.affiliation: Department of Chronic Communicable Disease, Center for Disease Control and Prevention of Jiangsu Province, Nanjing, Jiangsu Province, People's Republic of China.
authors.forename: Wei
authors.initials: W
authors.lastname: Lu
authors.forename: Cheng
authors.initials: C
authors.lastname: Chen
authors.forename: Yan
authors.initials: Y
authors.lastname: Shao
authors.forename: Jinyan
authors.initials: J
authors.lastname: Shi
authors.forename: Chongqiao
authors.initials: C
authors.lastname: Zhong
authors.forename: Dandan
authors.initials: D
authors.lastname: Yang
authors.forename: Honghuan
authors.initials: H
authors.lastname: Song
authors.forename: Guoli
authors.initials: G
authors.lastname: Li
authors.forename: Xiaoyan
authors.initials: X
authors.lastname: Ding
authors.forename: Hong
authors.initials: H
authors.lastname: Peng
authors.forename: Linyang
authors.initials: L
authors.lastname: Zhu
authors.forename: Yang
authors.initials: Y
authors.lastname: Zhou
authors.forename: Limei
authors.initials: L
authors.lastname: Zhu
mesh_terms: D000995:Antitubercular Agents; D002681:China / Q000453:epidemiology; D024901:Drug Resistance, Multiple, Bacterial / Q000502:physiology; D057166:High-Throughput Screening Assays / Q000379:methods; D006801:Humans; D007538:Isoniazid / Q000494:pharmacology*; D046228:Microarray Analysis / Q000379:methods*; D008826:Microbial Sensitivity Tests / Q000379:methods; D009169:Mycobacterium tuberculosis / Q000187:drug effects*; D015995:Prevalence; D012293:Rifampin / Q000494:pharmacology*; D012680:Sensitivity and Specificity; D013183:Sputum / Q000382:microbiology*; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis* / Q000453:epidemiology / Q000382:microbiology; D054928:Validation Studies as Topic
chemical_list: D000995:Antitubercular Agents; D007538:Isoniazid; D012293:Rifampin