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Introduction.DNA sequencing is currently the recommended method by WHO for rapid diagnosis of Multi Drug Resistant (MDR) TB specifically in countries with high TB/HIV burden.LPA ( Line Probe Assay) Hain Life Sciences is a DNA srip test which allows almost simultaneous identification of MTB and the most common genetic mutations causing resistance to Rifampicin(RIF) and Isoniazid (INH).Results are provided in just 5 hours compared to 6-8 weeks required for conventional Drug Susceptibility Testing.We decided to characterize the disease in Amajuba district,Kwazulu Natal province,South Africa after the introduction of this technology in our region.
Methods:Observational,cross Sectional study,conducted in 2 phases (January/june- July/December 2012) of 1420 adult patients attending Madadeni Regional Hospital as a referral centre(Phase 1) and 18 Primary Care Clinics(Phase 2 ) with symptoms suggestive of PTB.Inclusion criteria;1.Syntomatic known MDR/XDR TB contact case.2.Repeated clinical episode of PTB.3.Symptomatic PTB case after completion of intensice phase standard anti TB first line regimen.Single spot sputum specimens we analized applying Genotype MTB DR plus Version 2.0(Hain Life Science,Nehren,Germany.
Results:123/347 samples (35.9%) during Phase 1 and 267/1073(24.88%) during Phase 2 were positive for MTB DNA complex.95 % CI=0,409-0.308 and 0,273-0,222 respectively.80/123(65,04%) specimes in the first semester and 231/267(86.5%)harboured RIF/INH susceptible strains.95% CI=0,734-0,566 and 0,838-0,742 MDR was confirmed in 24,3 %(95% CI=0,316-0,170)and 13.8%(95%CI=0,174-0,093) over Phase 1 and 2 study periods.Monoresistance type mutations for RIF and INH frequency was 0,043 % and 0,041% respectively.
Conclusions: MTB DNA complex was detected in 1/3 of the samples.The frequency of MDR TB was lower than expected.RIF/INH monoresistance was uncommon.Inadequate quality of sputum specimens might hamper the accuracy of Genotype MTB DR plus assay.The molecular test improved prognosis of PTB cases by offering timely access to more appropriate anti TB regimes.