Published Paper Details:

Objective: Multi-drug resistance tuberculosis remains a crisis and threats to world health. Line Probe Assay is a molecular techniques for rapid diagnosis of second line drugs MDR-TB. But there is less sufficient information on the clinical viability of this test and a lack of evidence in the diagnosis of MDR-TB use of this Line Probe Assay technique in Indonesia. The aim of this study is to determine performance of line probe assay GenoType MTBDRsl VER 2.0 assay on rifampicin-resistance Mycobacterium tuberculosis isolates compared with phenotypic Lowenstein Jensen drug susceptibility test method (DST) as a gold standard. Methods : This research was used cross sectional study with analytic observational approach from January- June 2020. After being examine with Xpert MTB/RIF, a total of 26 rifampicin resistance Mycobacterium tuberculosis isolates were collected and tested with GenoType MTBDRsl VER 2.0 assay and phenotypic Drug Susceptibility Test (DST). Statistic analysis were performed to determine sensitivity, specificity, PPV, NPV and accuracy of second line tuberculosis drugs. Results: Our study found three fluoroquinolone resistant Mycobacterium tuberculosis isolates (11.5%) and one amikacin resistant Mycobacterium tuberculosis isolate (3,8%). The performance of GenoType MTBDRsl VER 2.0 assay is shown 100 % (95% CI 84,6-100 % ) sensitivity, 100% (95% CI 39,8-100 %) specificity, 100% (95% CI %) PPV, 100% (95% CI %) NPV and 100% (95% CI 86,8-100 %) accuracy. Conclusion: GenoType MTBDRsl VER 2.0 assay showed a high performance compared with phenotypic method to determine resistance of fluoroquinolone and Second Line Injectable Drugs.