GenoType MTBDRsl VER 2.0
Molecular Assay for detection of M. tuberculosis complex and its resistance to fluoroquinolones and second-line injectable drugs
Detection of MTB complex and its resistance to selected Group A and Group C agents
Tuberculosis (TB) is a bacterial infectious disease caused by Mycobacterium tuberculosis or by one of the other species of the M. tuberculosis (MTB) complex. TB is spread by aerosol, when people with active disease expel bacteria. It is estimated that more than 10 million new cases of TB arise globally every year, leading to an estimated 1.6 million deaths. TB treatment requires therapy over several months, which can fail due to mutations in the bacterial genome that result in drug resistance. XDR-TB is defined as TB that is resistant to rifampicin, plus any fluoroquinolone, and at least one additional Group A drug, such as bedaquiline and linezolid. In 2021 more than 25.000 cases of pre-XDR-TB and XDR-TB have been reported to the WHO. XDR-TB is extremely difficult to treat and requires a longer course of treatment. Furthermore, the respective therapy regimen needs to be carefully adapted to the individual infection drug resistance patterns, to ensure successful treatment outcomes and to prevent further spread of resistance to important first- and second-line TB drugs.
Therefore, rapid and reliable detection of resistance-mediating mutations is essential for fast and effective disease management at individual and public health level.
GenoType MTBDRsl VER 2.0 is recommended by the WHO for detection of resistances to fluoroquinolones and Second-line injectable drugs (SLID) in patients with confirmed multidrug-resistant tuberculosis or rifampicin-resistant tuberculosis (MDR/RR-TB). The results are available within 5 hours directly from patient specimens offering rapid and reliable information for an individual therapy planning.
MDR/RR-TB can be detected with GenoType MTBDRplus VER 2.0 in a first step – afterwards GenoType MTBDRsl VER 2.0 can be performed using the same DNA isolate. This step-wise approach saves valuable time in TB and resistance diagnostics.
GenoType MTBDRsl VER 2.0
GenoType MTBDRsl VER 2.0 identifies the MTB complex and its resistance to fluoroquinolones (FLQ) and SLID, such as amikacin, from smear-positive or -negative sputum specimens or cultivated samples. The detection of FLQ resistance is enabled by the detection of the most significant resistance-associated mutations of the gyrA and gyrB genes. For detection of SLID resistance, the 16S rRNA gene (rrs) and the promoter region of the eis gene are examined.
| Detection of: | M. tuberculosis complex and its resistances to fluoroquinolones and second-line injectable drugs |
| Sample Material | Smear-positive and -negative sputum and cultivated samples |
| Fluoroquinolone | Mutations in the gyrA and gyrB genes that are involved in fluoroquinolone resistance |
| Amikacin | Mutations in the rrs gene that are involved in SLID resistance |
| Kanamycin (for information only) |
Mutations in the eis gene that are involved in SLID resistance |
Enabled by DNA•STRIP technology
The well-established DNA•STRIP technology is based on multiplex PCR and reverse hybridization on a membrane strip with pre-determined target band locations. It enables highly efficient diagnostics for all throughputs with low implementation costs, making the platform suitable for laboratories of all sizes and needs. All DNA•STRIP products can be combined with each other. This permits joint execution of several human-genetic and microbiological parameters.
Low-cost implementation in mycobacteria routine
GenoType MTBDRsl VER 2.0 assay can be carried out with minimal investment, which means low-cost implementation for every laboratory size. DNA extraction can be performed manually with 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 (to be available soon as an IVDR instrument) as the respective PCR program for the assay, as well as other DNA•STRIP assays, is already pre-installed. For the subsequent detection, hybridization steps can be performed partially automated with the TwinCubator or fully automated with the GT-Blot 48.
Please contact your local representative for availability in your country.
Not for sale in the USA.
Legal Manufacturer is Hain Lifescience GmbH – A Bruker Company
