Zikun Huang1, Cheng Qin2, Jinghui Du3, Qing Luo1, Yaoxing Wang4, Wang Zhang5, Xi Zhang6, Guoliang Xiong7, Jie Chen1, Xiaomeng Xu1, Weiting Li1, Junming Li8. 1. Department of Clinical Laboratory, First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi 330006, China. 2. Intensive Care Unit, First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi 330006, China. 3. Department of Clinical Laboratory, First Teaching Hospital of Tianjin University of TCM, Tianjin 300193, China. 4. Clinical Microbiology Laboratory, Shanghai First People's Hospital, Shanghai 200431, China. 5. Clinical Microbiology Laboratory, University of Hong Kong-Shenzhen Hospital, Shenzhen, Guangdong 518053, China. 6. Department of Clinical Laboratory, Third Affiliated Hospital of Kunming Medical University, Kunming, Yunnan 650118, China. 7. Province Tuberculosis Reference Laboratory, Jiangxi Chest Hospital, Nanchang, Jiangxi 330006, China. 8. Department of Clinical Laboratory, First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi 330006, China lisir361@163.com.
Abstract
OBJECTIVES: To perform a multicentre study evaluating the performance of the microscopic observation drug susceptibility (MODS) assay for the detection of MDR-TB and XDR-TB in high-burden resource-limited settings. METHODS: We performed a prospective diagnostic accuracy study of drug-resistant TB suspects from outpatient and inpatient settings in five laboratories in China. Sputum was tested by smear microscopy, liquid [mycobacterial growth indicator tube (MGIT)] culture and the MODS assay at each site. Drug susceptibility testing (DST) was by MODS and an indirect 1% proportion method. The reference standard for Mycobacterium tuberculosis detection was growth on MGIT culture; the 1% proportion method was the reference standard for rifampicin, isoniazid, ofloxacin, kanamycin and capreomycin DST. RESULTS: M. tuberculosis was identified by reference standard culture among 213/532 (40.0%) drug-resistant TB suspects. Overall MODS sensitivity for M. tuberculosis detection was 87.8%-94.3% and specificity was 96.8%-100%. For drug-resistant TB diagnosis, excellent agreement was obtained for all drugs tested at the majority of sites. The accuracy was 87.1%-96.7% for rifampicin, 87.1%-93.3% for isoniazid, 92.7%-100% for ofloxacin, 90.9%-100% for kanamycin and 90.2%-100% for capreomycin. The median time to culture positivity was significantly shorter for MODS than for the MGIT liquid culture (8 days versus 11 days, P<0.001). The contamination rate ranged between 2.1% and 5.3%. CONCLUSIONS: In the study settings, MODS provided high sensitivity and specificity for rapid diagnosis of TB and drug-resistant TB. We consider it to have a strong potential for timely detection of MDR-TB and XDR-TB in high-burden resource-limited settings.
OBJECTIVES: To perform a multicentre study evaluating the performance of the microscopic observation drug susceptibility (MODS) assay for the detection of MDR-TB and XDR-TB in high-burden resource-limited settings. METHODS: We performed a prospective diagnostic accuracy study of drug-resistant TB suspects from outpatient and inpatient settings in five laboratories in China. Sputum was tested by smear microscopy, liquid [mycobacterial growth indicator tube (MGIT)] culture and the MODS assay at each site. Drug susceptibility testing (DST) was by MODS and an indirect 1% proportion method. The reference standard for Mycobacterium tuberculosis detection was growth on MGIT culture; the 1% proportion method was the reference standard for rifampicin, isoniazid, ofloxacin, kanamycin and capreomycin DST. RESULTS:M. tuberculosis was identified by reference standard culture among 213/532 (40.0%) drug-resistant TB suspects. Overall MODS sensitivity for M. tuberculosis detection was 87.8%-94.3% and specificity was 96.8%-100%. For drug-resistant TB diagnosis, excellent agreement was obtained for all drugs tested at the majority of sites. The accuracy was 87.1%-96.7% for rifampicin, 87.1%-93.3% for isoniazid, 92.7%-100% for ofloxacin, 90.9%-100% for kanamycin and 90.2%-100% for capreomycin. The median time to culture positivity was significantly shorter for MODS than for the MGIT liquid culture (8 days versus 11 days, P<0.001). The contamination rate ranged between 2.1% and 5.3%. CONCLUSIONS: In the study settings, MODS provided high sensitivity and specificity for rapid diagnosis of TB and drug-resistant TB. We consider it to have a strong potential for timely detection of MDR-TB and XDR-TB in high-burden resource-limited settings.
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Authors: Alvaro Proaño; David P Bui; José W López; Nancy M Vu; Marjory A Bravard; Gwenyth O Lee; Brian H Tracey; Ziyue Xu; Germán Comina; Eduardo Ticona; Daniel J Mollura; Jon S Friedland; David A J Moore; Carlton A Evans; Philip Caligiuri; Robert H Gilman Journal: Chest Date: 2018-03-17 Impact factor: 9.410