FluoroType^® MTBDR VER 2.0

Tuberculosis (TB) is a bacterial infectious disease passed on by aerosol. An estimated 10 million new cases of TB arise globally every year, leading to an estimated 1.4 million deaths. TB is caused by Mycobacterium tuberculosis or by one of the other species of the M. tuberculosis (MTB) complex. TB treatment requires therapy over several months, which can fail due to mutations that result in drug resistance. Undiagnosed drug-resistant TB can lead to inadequate treatment and is a major public health problem, with over 450,000 estimated cases in 2021. Therefore, rapid and reliable detection of resistance-mediating mutations is essential for fast intervention and effective disease management at individual and public health level.

FluoroType^® MTBDR VER 2.0 offers reliable detection of multi-drug resistant TB (MDR-TB) by reporting resistances to the two most important first-line drugs, rifampicin and isoniazid. In a single well, the test allows detection of the MTB complex alongside differentiation of up to 45 mutations in resistance-mediating rpoB, katG and inhA genes. The molecular genetic assay is powered by the innovative LiquidArray^® technology, providing next generation multiplexing. Moreover, the LiquidArray^® technology allows reliable detection of rare or so far unknown mutations in the target genes, guiding the doctors to initiate further investigations and subsequently a relevant therapy.

FluoroType^® MTBDR VER 2.0 is endorsed by the WHO as a test for the detection of pulmonary TB, and of rifampicin and isoniazid resistance, in people with signs and symptoms of pulmonary TB. Starting from DNA extraction from decontaminated sputum or culture samples, and following PCR set-up, amplification and detection are performed with the FluoroCycler^® XT. The FluoroSoftware^® XT-IVD generates results at a glance, in an easy to use, easy to interpret test report. The streamlined workflow allows detection of resistance-conferring mutations in just 2.5 hours making the FluoroType^® MTBDR VER 2.0 assay an indispensable tool for the diagnosis of MDR-TB.

Starting from decontaminated sputum or culture samples, automated DNA extraction is performed on the GenoXtract^®  (up to 12 samples) and on GenoXtract^® fleXT (12-96 samples). Alternatively, DNA can be extracted manually using FluoroLyse. In addition to automated DNA extraction, the GenoXtract^® fleXT also offers automated PCR set-up. Following PCR set-up, LiquidArray^® amplification and detection are performed with the FluoroCycler^® XT and the integrated FluoroSoftware^® XT-IVD software provides results at a glance.

The same DNA extract can be used in parallel or as a follow-up diagnostic with LiquidArray^® MTB-XDR VER 1.0 : a Bruker assay reporting resistances to fluoroquinolones, linezolid, amikacin and ethambutol in one PCR reaction. Together, the two assays allow for a very comprehensive coverage of drug resistances in TB in line with WHO guidelines.