An integrated approach to rapid diagnosis of tuberculosis and multidrug resistance using liquid culture and molecular methods in Russia

• Published in: PloS one 2009-09, Vol.4 (9), p.e7129-e7129
• Main Authors: Balabanova, Yanina, Drobniewski, Francis, Nikolayevskyy, Vladyslav, Kruuner, Annika, Malomanova, Nadezhda, Simak, Tatyana, Ilyina, Nailya, Zakharova, Svetlana, Lebedeva, Natalya, Alexander, Heather L, O'Brien, Rick, Sohn, Hojoon, Shakhmistova, Anastasia, Fedorin, Ivan
• Format: Article
• Language: English
• Subjects: Accuracy; Antitubercular agents; Assaying; Automation; Bacterial Typing Techniques; Bacteriological Techniques - methods; Clinics; Communicable Disease Control - methods; Comparative analysis; Cost analysis; Cost-Benefit Analysis; Culture; Diagnosis; Disease control; Drug resistance; Feasibility studies; Humans; Hybridization; Infectious Diseases/Respiratory Infections; Isoniazid; Isoniazid - pharmacology; Laboratories; Liquid culture; Logistics; Medical diagnosis; Medicine; Methods; Microbial drug resistance; Microbial Sensitivity Tests; Multidrug resistance; Multidrug resistant organisms; Mycobacterium; Mycobacterium tuberculosis; Mycobacterium tuberculosis - genetics; Phenotype; Public Health and Epidemiology/Health Policy; Public Health and Epidemiology/Health Services Research and Economics; Public Health and Epidemiology/Infectious Diseases; Resistance factors; Respiratory Medicine/Respiratory Infections; Rifampin; Rifampin - pharmacology; Risk analysis; Risk Factors; Russia; Smear; Sputum; Studies; Supranationalism; Tuberculosis; Tuberculosis - diagnosis; Tuberculosis - genetics; Tuberculosis, Multidrug-Resistant - diagnosis; Tuberculosis, Multidrug-Resistant - genetics
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0007129

To analyse the feasibility, cost and performance of rapid tuberculosis (TB) molecular and culture systems, in a high multidrug-resistant TB (MDR TB) middle-income region (Samara, Russia) and provide evidence for WHO policy change. Performance and cost evaluation was conducted to compare the BACTEC MGIT 960 system for culture and drug susceptibility testing (DST) and molecular systems for TB diagnosis, resistance to isoniazid and rifampin, and MDR TB identification compared to conventional Lowenstein-Jensen culture assays. 698 consecutive patients (2487 sputum samples) with risk factors for drug-resistant tuberculosis were recruited. Overall M. tuberculosis complex culture positivity rates were 31.6% (787/2487) in MGIT and 27.1% (675/2487) in LJ (90.5% and 83.2% for smear-positive specimens). In total, 809 cultures of M. tuberculosis complex were isolated by any method. Median time to detection was 14 days for MGIT and 36 days for LJ (10 and 33 days for smear positive specimens) and indirect DST in MGIT took 9 days compared to 21 days on LJ. There was good concordance between DST on LJ and MGIT (96.8% for rifampin and 95.6% for isoniazid). Both molecular hybridization assay results correlated well with MGIT DST results, although molecular assays generally yielded higher rates of resistance (by approximately 3% for both isoniazid and rifampin). With effective planning and logistics, the MGIT 960 and molecular based methodologies can be successfully introduced into a reference laboratory setting in a middle incidence country. High rates of MDR TB in the Russian Federation make the introduction of such assays particularly useful.