title: Multicenter evaluation of genechip for detection of multidrug-resistant Mycobacterium tuberculosis.
abstract: Drug-resistant tuberculosis (TB), especially multidrug-resistant TB (MDR-TB), is still one of the most serious threats to TB control worldwide. Early diagnosis of MDR-TB is important for effectively blocking transmission and establishing an effective protocol for chemotherapy. Genechip is a rapid diagnostic method based on molecular biology that overcomes the poor biosafety, time consumption, and other drawbacks of traditional drug sensitivity testing (DST) that can detect MDR-TB. However, the Genechip approach has not been effectively evaluated, especially in limited-resource laboratories. In this study, we evaluated the performance of Genechip for MDR-TB in 1,814 patients in four prefectural or municipal laboratories and compared its performance with that of traditional DST. The results showed that the sensitivity and specificity of Genechip were 87.56% and 97.95% for rifampin resistance and 80.34% and 95.82% for isoniazid resistance, respectively. In addition, we found that the positive grade of the sputum smears influenced the judgment of results by Genechip. The test judged only 75% of the specimens of "scanty" positive grade. However, the positive grade of the specimens showed no influence on the accuracy of Genechip. Overall, the study suggests that, in limited-resource laboratories, Genechip showed high sensitivity and specificity for rifampin and isoniazid resistance, making it a more effective, rapid, safe, and cost-beneficial method worthy of broader use in limited-resource laboratories in China.
authors.affiliation: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Pang
authors.forename: Hui
authors.initials: H
authors.lastname: Xia
authors.forename: Zhiying
authors.initials: Z
authors.lastname: Zhang
authors.forename: Junchen
authors.initials: J
authors.lastname: Li
authors.forename: Yi
authors.initials: Y
authors.lastname: Dong
authors.forename: Qiang
authors.initials: Q
authors.lastname: Li
authors.forename: Xichao
authors.initials: X
authors.lastname: Ou
authors.forename: Yuanyuan
authors.initials: Y
authors.lastname: Song
authors.forename: Yufeng
authors.initials: Y
authors.lastname: Wang
authors.forename: Richard
authors.initials: R
authors.lastname: O'Brien
authors.forename: Kai Man
authors.initials: KM
authors.lastname: Kam
authors.forename: Junying
authors.initials: J
authors.lastname: Chi
authors.forename: Shitong
authors.initials: S
authors.lastname: Huan
authors.forename: Daniel P
authors.initials: DP
authors.lastname: Chin
authors.forename: Yanlin
authors.initials: Y
authors.lastname: Zhao
mesh_terms: D001431:Bacteriological Techniques / Q000379:methods*; D002681:China; D024901:Drug Resistance, Multiple, Bacterial; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D009169:Mycobacterium tuberculosis / Q000187:drug effects / Q000235:genetics* / Q000302:isolation & purification*; D020411:Oligonucleotide Array Sequence Analysis / Q000379:methods*; D012680:Sensitivity and Specificity; D013183:Sputum / Q000382:microbiology; D013997:Time Factors; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis*