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Open Access Highly Accessed Research article

Rapid screening of MDR-TB using molecular Line Probe Assay is feasible in Uganda

Heidi Albert1*, Freddie Bwanga23, Sheena Mukkada1, Barnabas Nyesiga1, Julius Patrick Ademun1, George Lukyamuzi1, Melles Haile4, Sven Hoffner4, Moses Joloba23 and Richard O'Brien5

Author Affiliations

1 Foundation for Innovative New Diagnostics (FIND), Kampala, Uganda

2 Department of Medical Microbiology, Makerere University, Kampala, Uganda

3 National Tuberculosis Reference Laboratory, Wandegeya, Kampala, Uganda

4 Department of Bacteriology, Swedish Institute for Infectious Disease Control, Solna, Sweden

5 Foundation for Innovative New Diagnostics, Geneva, Switzerland

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BMC Infectious Diseases 2010, 10:41  doi:10.1186/1471-2334-10-41

Published: 26 February 2010

Abstract

Background

About 500 new smear-positive Multidrug-resistant tuberculosis (MDR-TB) cases are estimated to occur per year in Uganda. In 2008 in Kampala, MDR-TB prevalence was reported as 1.0% and 12.3% in new and previously treated TB cases respectively. Line probe assays (LPAs) have been recently approved for use in low income settings and can be used to screen smear-positive sputum specimens for resistance to rifampicin and isoniazid in 1-2 days.

Methods

We assessed the performance of a commercial line probe assay (Genotype MTBDRplus) for rapid detection of rifampicin and isoniazid resistance directly on smear-positive sputum specimens from 118 previously treated TB patients in a reference laboratory in Kampala, Uganda. Results were compared with MGIT 960 liquid culture and drug susceptibility testing (DST). LPA testing was also performed in parallel in a University laboratory to assess the reproducibility of results.

Results

Overall, 95.8% of smear-positive specimens gave interpretable results within 1-2 days using LPA. Sensitivity, specificity, positive and negative predictive values were 100.0%, 96.1%, 83.3% and 100.0% for detection of rifampicin resistance; 80.8%, 100.0%, 100.0% and 93.0% for detection of isoniazid resistance; and 92.3%, 96.2%, 80.0% and 98.7% for detection of multidrug-resistance compared with conventional results. Reproducibility of LPA results was very high with 98.1% concordance of results between the two laboratories.

Conclusions

LPA is an appropriate tool for rapid screening for MDR-TB in Uganda and has the potential to substantially reduce the turnaround time of DST results. Careful attention must be paid to training, supervision and adherence to stringent laboratory protocols to ensure high quality results during routine implementation.