Tuberculosis (TB) is a bacterial infectious disease leading to estimated 10 million new cases and 1.4 million deaths globally every year. TB is caused by Mycobacterium tuberculosis or by one of the additional species of the M. tuberculosis complex (MTBC) that are transmitted by aerosol. Without treatment, people with active TB can infect 5-15 further individuals per year and have approximately a 45% risk of death, which doubles in presence of other conditions such as AIDS. Therefore, rapid and reliable detection of MTBC is essential for fast intervention and effective disease management at individual and public health level.
FluoroType® MTB VER 1.0 assay offers highly sensitive detection of MTBC by reporting the presence or absence of MTBC-specific genes in patient samples and provides the results in a user-friendly easy-to-interpret report. Starting with DNA extraction from decontaminated direct patient samples, and following PCR set-up with the ready-to-use amplification mix, the subsequent steps run fully automated with a dedicated FluoroCycler® to generate results at a glance. The streamlined workflow allows specific detection of MTBC with FluoroType® MTB VER 1.0 in just 3 hours, enabling the doctors to make timely decisions on the initiation of appropriate therapy.
FluoroType® MTB VER 1.0 offers rapid and reliable detection of M. tuberculosis complex directly from decontaminated pulmonary and extrapulmonary clinical specimens (except for whole blood). Thanks to its exceptional performance, FluoroType® MTB VER 1.0 has been endorsed by WHO for TB detection in pulmonary samples.
DNA extraction is performed manually with a rapid three-step protocol using FluoroLyse reagent. The DNA amplification and target detection of up to 12 samples takes place in the FluoroCycler® 12, with the option to run up to 4 units simultaneously with one computer. The latter offers the flexibility to process up to 48 samples in parallel.
The PCR assays based on FluoroType® technology offer rapid and reliable results thanks to the carefully designed fluorophores and streamlined workflows using dedicated devices. FluoroType® MTB VER 1.0 comes with a validation for an extensive range of sample materials, different extraction methods and a 12-sample cycler with a small footprint.
MTBC-positive sputum samples can be tested further for first-line and second-line drug resistances using FluoroType® MTBDR VER 2.0 and LiquidArray® MTB-XDR assays . These additional FluoroType® assays allow in-depth analysis of resistances to a range of anti-TB drugs with sequencing-like results and are available on the multi-channel FluoroCycler® XT.
Starting from decontaminated direct patient samples, DNA is extracted manually with FluoroLyse VER 1.0. Following PCR setup, FluoroType® technology-based amplification and detection are performed with the dedicated PCR cycler and the integrated FluoroSoftware® software provides results at a glance.
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Not for sale in the USA.
Legal Manufacturer is Hain Lifescience GmbH – A Bruker Company