Nontuberculous mycobacteria (NTM) are atypical mycobacteria commonly found in the environment such as water, soil and household dust, and can occasionally infect humans. Some of the most common NTM species, such as members of the M. avium complex and the M. abscessus complex may lead to severe disease, commonly manifesting the lung, skin and soft tissues. People with compromised immune system or with chronic lung conditions are particularly at risk of requiring medical intervention. Treatment frequently requires extended individual antibiotic therapy, with macrolides and aminoglycosides being important components of the therapy. Presenting a challenge to therapy management are the emerging drug resistance within the M. avium complex, as well as the spread of subspecies with intrinsic macrolide resistance, such as M. abscessus subsp. abscessus. Early detection of drug resistance allows doctors to initiate appropriate treatment and increase the chances of a successful outcome.
The GenoType NTM-DR VER 1.0 molecular assay enables rapid and reliable detection of resistances to macrolides and aminoglycosides in clinically relevant NTM within the M. avium and M. abscessus complexes. Moreover, the assay allows specific detection of the M. avium complex members as well as differentiation of M. abscessus subspecies with varying intrinsic drug resistances.
A first detection and differentiation of clinically relevant NTM species, as well as the closely related M. tuberculosis complex, is facilitated by the GenoType Mycobacterium CM VER 2.0 and GenoType Mycobacterium AS VER 1.0 assays. Building on the results of these assays in a step-wise approach, a molecular resistance testing and subspecies differentiation is enabled by the GenoType NTM-DR VER 1.0. Together the three assays cover a comprehensive panel of the most encountered and clinically relevant mycobacteria at species and subspecies level. The essential drug resistance information offered by the GenoType NTM-DR VER 1.0 enables doctors to make appropriate therapy decisions for successful outcomes.
The GenoType NTM-DR VER 1.0 molecular assay detects macrolide and aminoglycoside resistance in several clinically relevant NTMs from cultured sample material. The reliable detection of macrolide resistance is enabled by identification of distinct mutations within the rrl gene or, specific to members of the M. abscessus complex, the erm(41) gene. Aminoglycoside resistance is determined through detection of mutations within the rrs gene. Simultaneously, GenoType NTM-DR VER 1.0 allows species and subspecies differentiation, specifically M. avium, M. intracellulare and M. chimaera within the M. avium complex, as well as the M. abscessus subsp. abscessus, M. abscessus subsp. massiliense, M. abscessus subsp. bolletii and M. chelonae within the M. abscessus complex. Complementary to GenoType Mycobacterium CM VER 2.0 and GenoType Mycobacterium AS VER 1.0, the assay can be run on the same DNA extraction. A step-wise approach with detection and subsequent subspecies differentiation and resistance testing is therefore easy to implement.
The well-established DNA•STRIP technology is based on multiplex PCR and reverse hybridization. The platform offers fast and reliable diagnostic options for all throughputs with minimal implementation costs. All DNA•STRIP-based products can be combined with each other during processing for comprehensive sample analysis. This enables joint execution of several human-genetic and microbiological diagnostic parameters.
The GenoType NTM-DR VER 1.0 assay can be performed without high-budget investments. The low-cost implementation makes this diagnostic tool accessible to laboratories of any size. DNA extraction is performed manually with GenoLyse® VER 1.0. The subsequent PCR reaction can be performed in a standard thermal cycler. The GTQ-Cycler 96 is offered as a convenient solution with the respective PCR program for the assay, as well as for other DNA•STRIP assays, is already pre-installed. For the subsequent detection the hybridization steps can be performed partially or fully automated with the TwinCubator or the GT-Blot 48, respectively.
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Not for sale in the USA.
Legal Manufacturer is Hain Lifescience GmbH – A Bruker Company