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


RESULTS
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).


CONCLUSIONS
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.
Balabanova
Yanina
Y
National Mycobacterium Reference Laboratory, Institute of Cell and Molecular Sciences, Queen Mary College, Barts and the London School of Medicine, University of London, London, United Kingdom. y.balabanova@qmul.ac.uk
Drobniewski
Francis
F
Nikolayevskyy
Vladyslav
V
Kruuner
Annika
A
Malomanova
Nadezhda
N
Simak
Tatyana
T
Ilyina
Nailya
N
Zakharova
Svetlana
S
Lebedeva
Natalya
N
Alexander
Heather L
HL
O'Brien
Rick
R
Sohn
Hojoon
H
Shakhmistova
Anastasia
A
Fedorin
Ivan
I
D015373:Bacterial Typing Techniques; D001431:Bacteriological Techniques / Q000379:methods; D003140:Communicable Disease Control / Q000379:methods*; D003362:Cost-Benefit Analysis; D006801:Humans; D007538:Isoniazid / Q000494:pharmacology; D008826:Microbial Sensitivity Tests; D009169:Mycobacterium tuberculosis / Q000235:genetics*; D010641:Phenotype; D012293:Rifampin / Q000494:pharmacology; D012307:Risk Factors; D012426:Russia; D014376:Tuberculosis / Q000175:diagnosis* / Q000235:genetics; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis* / Q000235:genetics
D007538:Isoniazid; D012293:Rifampin