Objective 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. Methods 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. Findings 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). Conclusion 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.
Migliori GB, Lange C, Girardi E, Centis R, Besozzi G, et al. (2008) Extensively drug-resistant tuberculosis is worse than multidrug-resistant tuberculosis: different methodology and settings, same results. Clin Infect Dis 46: 958–959.
Leimane V, Riekstina V, Holtz TH, Zarovska E, Skripconoka V, et al. (2005) Clinical outcome of individualised treatment of multidrug-resistant tuberculosis in Latvia: a retrospective cohort study. Lancet 365: 318–326.
Drobniewski F, Balabanova Y, Nikolayevsky V, Ruddy M, Kuznetzov S, et al. (2005) Drug-resistant tuberculosis, clinical virulence, and the dominance of the Beijing strain family in Russia. Jama 293: 2726–2731.
Ruddy M, Balabanova Y, Graham C, Fedorin I, Malomanova N, et al. (2005) Rates of drug resistance and risk factor analysis in civilian and prison patients with tuberculosis in Samara Region, Russia. Thorax 60: 130–135.
Bergmann JS, Fish G, Woods GL (2000) Evaluation of the BBL MGIT (Mycobacterial growth indicator tube) AST SIRE system for antimycobacterial susceptibility testing of Mycobacterium tuberculosis to 4 primary antituberculous drugs. Arch Pathol Lab Med 124: 82–86.
Goloubeva V, Lecocq M, Lassowsky P, Matthys F, Portaels F, et al. (2001) Evaluation of mycobacteria growth indicator tube for direct and indirect drug susceptibility testing of Mycobacterium tuberculosis from respiratory specimens in a Siberian prison hospital. J Clin Microbiol 39: 1501–1505.
Tortoli E, Benedetti M, Fontanelli A, Simonetti MT (2002) Evaluation of automated BACTEC MGIT 960 system for testing susceptibility of Mycobacterium tuberculosis to four major antituberculous drugs: comparison with the radiometric BACTEC 460TB method and the agar plate method of proportion. J Clin Microbiol 40: 607–610.
Somoskovi A, Song Q, Mester J, Tanner C, Hale YM, et al. (2003) Use of molecular methods to identify the Mycobacterium tuberculosis complex (MTBC) and other mycobacterial species and to detect rifampin resistance in MTBC isolates following growth detection with the BACTEC MGIT 960 system. J Clin Microbiol 41: 2822–2826.
Bardarov S Jr, Dou H, Eisenach K, Banaiee N, Ya S, et al. (2003) Detection and drug-susceptibility testing of M. tuberculosis from sputum samples using luciferase reporter phage: comparison with the Mycobacteria Growth Indicator Tube (MGIT) system. Diagn Microbiol Infect Dis 45: 53–61.
Mokrousov I, Bhanu NV, Suffys PN, Kadival GV, Yap SF, et al. (2004) Multicenter evaluation of reverse line blot assay for detection of drug resistance in Mycobacterium tuberculosis clinical isolates. J Microbiol Methods 57: 323–335.
Drobniewski FA, Watterson SA, Wilson SM, Harris GS (2000) A clinical, microbiological and economic analysis of a national service for the rapid molecular diagnosis of tuberculosis and rifampicin resistance in Mycobacterium tuberculosis. J Med Microbiol 49: 271–278.
Seagar AL, Prendergast C, Emmanuel FX, Rayner A, Thomson S, et al. (2008) Evaluation of the GenoType Mycobacteria Direct assay for the simultaneous detection of the Mycobacterium tuberculosis complex and four atypical mycobacterial species in smear-positive respiratory specimens. J Med Microbiol 57: 605–611.
Somoskovi A, Dormandy J, Mitsani D, Rivenburg J, Salfinger M (2006) Use of smear-positive samples to assess the PCR-based genotype MTBDR assay for rapid, direct detection of the Mycobacterium tuberculosis complex as well as its resistance to isoniazid and rifampin. J Clin Microbiol 44: 4459–4463.
Hillemann D, Rusch-Gerdes S, Richter E (2007) Evaluation of the GenoType MTBDRplus assay for rifampin and isoniazid susceptibility testing of Mycobacterium tuberculosis strains and clinical specimens. J Clin Microbiol 45: 2635–2640.
Drobniewski F, Balabanova Y, Ruddy M, Weldon L, Jeltkova K, et al. (2002) Rifampin- and multidrug-resistant tuberculosis in Russian civilians and prison inmates: dominance of the Beijing strain family. Emerg Infect Dis 8: 1320–1326.
Laszlo A, Rahman M, Espinal M, Raviglione M (2002) Quality assurance programme for drug susceptibility testing of Mycobacterium tuberculosis in the WHO/IUATLD Supranational Reference Laboratory Network: five rounds of proficiency testing, 1994–1998. Int J Tuberc Lung Dis 6: 748–756.
Hillemann D, Richter E, Rusch-Gerdes S (2006) Use of the BACTEC Mycobacteria Growth Indicator Tube 960 automated system for recovery of Mycobacteria from 9,558 extrapulmonary specimens, including urine samples. J Clin Microbiol 44: 4014–4017.
Kruuner A, Yates M, Drobniewski F (2006) Critical concentration setting and evaluation of MGIT 960 antimicrobial susceptibility testing to first- and second line antimicrobial drugs with clinical drug resistant strains of Mycobacteirum tuberculosis. J Clin Microbiol 44: 811–818.
Nikolayevsky V, Brown T, Balabanova Y, Ruddy M, Fedorin I, et al. (2004) Detection of mutations associated with isoniazid and rifampin resistance in Mycobacterium tuberculosis isolates from Samara Region, Russian Federation. J Clin Microbiol 42: 4498–4502.
Srisuwanvilai LO, Monkongdee P, Podewils LJ, Ngamlert K, Pobkeeree V, et al. (2008) Performance of the BACTEC MGIT 960 compared with solid media for detection of Mycobacterium in Bangkok, Thailand. Diagn Microbiol Infect Dis 61: 402–407.
Giampaglia CM, Martins MC, Vieira GB, Vinhas SA, Telles MA, et al. (2007) Multicentre evaluation of an automated BACTEC 960 system for susceptibility testing of Mycobacterium tuberculosis. Int J Tuberc Lung Dis 11: 986–991.
Somoskovi A, Clobridge A, Larsen SC, Sinyavskiy O, Surucuoglu S, et al. (2006) Does the MGIT 960 system improve the turnaround times for growth detection and susceptibility testing of the Mycobacterium tuberculosis complex? J Clin Microbiol 44: 2314–2315.
Nikolayevskyy V, Balabanova Y, Simak T, Malomanova N, Fedorin I, et al. (2009) Performance of the Genotype(R) MTBDRPlus assay in the diagnosis of tuberculosis and drug resistance in Samara, Russian Federation. BMC Clin Pathol 9: 2.