GenoType LepraeDR VER 1.0
Molecular assay for identification of resistance to rifampicin, ofloxacin, and dapsone of Mycobacterium leprae
Detection of Mycobacterium leprae and its resistance to rifampicin, ofloxacin and dapsone
Leprosy, also known as Hansen’s disease, is a chronic infectious disease, caused by Mycobacterium leprae. The bacteria affect the skin, peripheral nerves, mucous membranes, eyes and internal organs, with symptoms appearing within 2-4 years of infection. Once diagnosed, leprosy is curable with a 6-12 month multidrug therapy and if left untreated, it can lead to permanent disability.
Leprosy occurs in more than 120 countries, with over 200,000 new cases reported every year, with drug resistance on the rise, accounting for around 11% of all cases. Drug-resistance testing is particularly challenging as M. leprae does not grow in vitro and mouse footpad tests can take months to complete. This renders genetic testing a key step in the rapid diagnosis of drug-resistant leprosy and in ensuring appropriate therapy can be initiated in a timely manner and maximising the likelihood of treatment success.
GenoType LepraeDR VER 1.0 offers a rapid solution for the detection of M. leprae within 5 hours from AFB (acid-fast bacilli)-positive skin biopsies and simultaneously provides information on mutations conferring resistances to three most important drugs for leprosy treatment: rifampicin, ofloxacin and dapsone.
This molecular genetic assay is part of the broader comprehensive portfolio of Bruker’s DNA•STRIP assays, used by mycobacteria laboratories worldwide and offering seamless implementation into existing workflows.
Fast and reliable detection of drug-resistant leprosy
The reliable identification of rifampicin resistance is enabled by the detection of the most significant mutations of the rpoB gene. For testing the ofloxacin resistance, the gyrA gene is examined and for testing the dapsone resistance, the folP1 gene is analyzed. As an aid for diagnosis, the GenoType LepraeDR VER 1.0 test assists clinicians in making an informed decision on how to treat their patients with the most appropriate therapy.
Low-cost implementation in mycobacteria laboratories
Low-cost requirements for implementation of DNA•STRIP assays mean that the GenoType LepraeDR VER 1.0 assay can be carried out with minimal investment. DNA extraction from skin biopsies is performed manually in a few steps using standard glass bead, heating and ultrasonic methods.
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 note, the test is intended for use by clinical laboratory professionals only.
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
