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 PCR reaction, the test allows detection of the MTB complex alongside differentiation of up to 45 mutations in resistance-mediating rpoB and katG genes, and the inhA promoter region. 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 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 3 hours making the FluoroType® MTBDR VER 2.0 assay an indispensable tool for the diagnosis of MDR-TB.
The FluoroType MTBDR VER 2.0 enables highly sensitive MTB complex detection facilitated by the dual target approach, which includes the multi-copy IS6110 element. Rapid and reliable detection of resistance-mediating mutations is essential for determination of treatment courses to ensure successful outcomes. Powered by LiquidArray®, FluoroType® MTBDR VER 2.0 offers comprehensive coverage of the most prevalent resistance-mediating mutations in the rpoB and katG genes and the inhA promoter region in a single PCR reaction. The sequencing-like results provide information on resistance to isoniazid and rifampicin and thereby help reduce delays in diagnosis and mitigate the risk of incorrect treatment regimens and patient health deterioration.
LiquidArray® from Bruker is a next generation multiplexing PCR-based technology. It is underpinned by the unique features of the FluoroCycler® XT – Bruker’s high performance thermocycler. With precise temperature control and no optical cross-talk or colour compensation, assays are designed with a high number of targets per optical channel. LiquidArray® assays are automatically interpreted and reported providing advanced multiplex results at a glance in a familiar, easy to use format.
LiquidArray® brings next generation multiplexing for infectious disease diagnostics to the routine clinical microbiology laboratory.
Starting from native sputum liquefied with Liquefaction Set VER 1.0 or from NALC-NaOH 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 from NALC-NaOH decontaminated sputum or culture samples 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.
Where validated, 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.
Please contact your local representative for availability in your country.
Not for sale in the USA.
Legal manufacturer is Hain Lifescience GmbH, Nehren · Germany, info.mdx.de@bruker.com, Phone +49 (0) 7473-9451-0
The legal manufacturer of GenoXtract® fleXT is Hamilton Bonaduz AG, Via Crusch 8, CH-7402 Bonaduz, Switzerland.