GenoType MTBDRplus 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 multidrug-resistant TB (MDR-TB) can lead to inadequate treatment and is a major public health problem, with over 450,000 cases of drug-resistant TB 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.

GenoType MTBDRplus VER 2.0 is recommended by the WHO for the detection of MTB complex in combination with resistance to rifampicin and isoniazid. The molecular genetic assay is based on the well-established DNA•STRIP technology, which  combines specific multiplex PCR followed by hybridization on a membrane strip – with result available within 5 hours directly from patient specimens. The most significant loci of well-established resistance genes are probed with some of the most common mutations specifically reported. The assay has been adopted by mycobacteria laboratories worldwide proving to be an essential tool in the fight against MDR-TB.

Depending on the sample throughput, GenoType MTBDRplus can be processed flexibly. DNA extraction is performed manually using GenoLyse^® VER 1.0. The subsequent PCR reaction takes place in a standard thermal cycler. The most convenient way is to use the GTQ-Cycler 96 as the respective PCR programs for pulmonary and culture samples with the assay, as well as other DNA•STRIP assays, are already pre-installed. The flexibility applies to the subsequent detection: hybridization steps can be performed partially automated with the TwinCubator or fully automated with the GT-Blot 48.