P134

Introduction: Extensively drug-resistant tuberculosis (XDR-TB) and pre-XDR-TB are a major challenge to TB control due to their complex diagnosis and obstacles in treatment. With LiquidArray® MTB-XDR VER 1.0 Hain Lifescience provides an assay for rapid diagnosis of XDR-TB. Besides detection of Mycobacterium tuberculosis complex (MTBC) and its mutations conferring resistance to fluoroquinolones, amikacin, and ethambutol, the assay can also detect the most significant mutations conferring resistance to the group A drug Linezolid.

Methods: As starting material patient specimens and cultivated samples are used. DNA extraction is performed manually or automated with the GenoXtract® fleXT nucleic acid extraction system allowing high sample throughput with minimal hands-on time. Amplification, detection, and automated result interpretation is performed in the FluoroCycler® XT system within one single tube.

Results: An excellent performance of the assay could be demonstrated in the analytical study for all parameters investigated, including analytical sensitivity and analytical specificity. In an extensive clinical study, which focused on resistance detection for fluoroquinolones, amikacin, ethambutol and linezolid a high sensitivity and excellent specificity for MTBC and resistance detection was shown from sputum and culture samples.

Summary: LiquidArray MTB-XDR VER1.0 is a powerful tool for reliable detection of resistances related to XDR-TB.