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Analytical and Clinical performance evaluation of the FluoroType® MTBDR VER 2.0 with Dual Target Detection of Mycobacterium tuberculosis Complex from Native Sputum and Culture

M Eckart(1) L Wolf(1) S Fischer(1) V Allerheiligen(1)



The WHO-endorsed FluoroType® MTBDR VER 2.0 is an important tool in diagnosis of TB and its resistance-mediating mutations against first-line antibiotics rifampicin and isoniazid. The multi-copy target IS6110 was integrated into the FluoroType MTBDR VER 2.0 as a second target for M. tuberculosis complex (MTBC) detection. In this study we determined the analytical and clinical performance of the modified assay.


The modified FluoroType MTBDR VER 2.0 in combination the Liquefaction Set VER 1.0 allows easy and simultaneous detection of MTBC and its resistance to rifampicin and isoniazid directly from native sputum specimens. In total 8 workflows for manual and automated DNA extraction from native sputum and culture samples have been evaluated using the GenoXtract® and GenoXtract® fleXT instruments in combination with the FluoroCycler® XT.


Integration of IS6110 leads to a high sensitivity of MTBC detection. The FluoroType MTBDR VER 2.0 allows reliable detection and identification of most relevant mutations in rpoB, katG and the inhA promoter region responsible for resistance to rifampicin and isoniazid. It also identifies silent mutations within rpoB. The Liquefaction Set VER 1.0 inactivates and liquifies native sputum very effectively in one step. The excellent performance for MTBC and resistance detection was also demonstrated in a clinical study with ~600 patient samples.


The modified FluoroType MTBDR VER 2.0 enables sensitive detection of MTBC and identification of mutations directly from native sputum specimens. Additionally, NALC-NaOH decontaminated sputum samples and culture samples can be analyzed.

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