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Meaza, A., Desta, K., Kebede, A., Yaregal, Z., Dagne, Z., & Moga, S., et al. (2016). Evaluation of the diagnostic performance of mtbdrplus ver 2.0 line probe assay for the detection of mdr-tb in sputum samples referred to national tb reference laboratory, ethiopian public health institute. International Journal of Infectious Diseases, 45, 400. 
Resource type: Journal Article
DOI: 10.1016/j.ijid.2016.02.855
ID no. (ISBN etc.): 12019712
BibTeX citation key: Meaza2016a
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Categories: General
Creators: Addise, Dagne, Dasho, Desta, Diriba, Getahun, Kebede, Meaza, Moga, Molalign, Tadesse, Yaregal, Yenew
Collection: International Journal of Infectious Diseases
Attachments   URLs   http://dx.doi.org/ ... j.ijid.2016.02.855
Abstract
Background: Multi drug resistant tuberculosis(MDR-TB) is more difficult to diagnose and treat, leading to high mortality. Accurate and rapid detection of MDR-TB is critical for timely initiation of treatment. Evaluating new drug resistance diagnostic tools such as Genotype MTBDRplus VER 2.0 assay offer opportunity to scale up drug susceptibility testing(DST) capacity in Ethiopia. Methods & Materials: A cross sectional study was conducted from December to August, 2015 on presumptive MDR-TB patients. Analysis of 72 smear positive and 197 smear negative sputum samples was done with Genotype MTBDRplus VER 2.0 assay and compared with the reference, BACTEC MGIT 960 culture and DST. Sensitivity, specificity, PPV and NPV of the MTBDRplus VER 2.0 assay was calculated, comparing the results with the reference method and results was interpreted based on 95% confidence interval, statistical significant was taken at p-value <0.05. Results: The sensitivity, specificity, PPV and NPV of Genotype MTBDRplus VER 2.0 assay were 96.4, 100, 100 and 96.9%, respectively for the detection of MDR-TB from direct smear positive sputum samples. Only 14(54%) samples had valid results with LPA among the 26 smear negative culture positive samples. The remaining 8(30.6%) and 4(15.4%) were invalid and negative with LPA, respectively. The sensitivity and specificity of Genotype MTBDRplus VER 2.0 assay was 100% for the detection of MDR-TB among 14 direct smear negative and culture positive sputum samples. The most common mutations associated with RMP and INH resistance was S531L and S315TL, respectively. A single rare mutation (C15T/A16G) was also detected in this study. Conclusion: The diagnostic performance of Genotype MTBDRplus VER 2.0 assay in direct smear positive sputum sample was highly sensitive and specific for early detection of MDR-TB. However, the diagnostic performance of Genotype MTBDRplus VER 2.0 assay in direct smear negative sputum sample was low and showed high level of invalid results so it is unlikely to implement Genotype MTBDRplus VER 2.0 assay for the detection of MDR-TB in direct smear negative sample in our routine settings until the method is optimized. Hence, large scale further studies are needed in direct smear negative samples.