Summary Objective The objective of this study was to establish breakpoint concentrations for the fluoroquinolones (MOX and OFX) and injectable second-line drugs (AMK, KAN and CAP) using the MODS assay. Setting A multinational study conducted between February 2011 and August 2012 in Peru, India, Moldova and South Africa. Design First phase determined the breakpoints to the fluoroquinolones and injectable second-line drugs (n = 58). Second phase evaluated the MODS second-line DST as an indirect test compared to MGIT DST (n = 89). The third (n = 30) and fourth (n = 156) phases determined reproducibility and concordance of the MODS 2nd line DST directly from sputum. Results Breakpoints for moxifloxacin (0.5 μg/ml), ofloxacin (1 μg/ml), amikacin (2 μg/ml), kanamycin (5 μg/ml) and capreomycin (2.5 μg/ml) were determined. In all phases the MODS results were highly concordant with MGIT DST. The few discrepancies suggest that the MODS breakpoint concentrations for some drugs may be too low. Conclusion The MODS second-line DST yielded comparable results to MGIT second-line DST, and is thus a promising alternative. Further studies are needed to confirm the accuracy of the drug breakpoints and the reliability of the MODS second-line DST as a direct test.
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