GenoType Mycobacterium CM VER 2.0 and GenoType Mycobacterium AS VER 1.0
Molecular assays for detection of M. tuberculosis complex and differentiation of clinically relevant nontuberculous mycobacteria
Identification and differentiation of the M. tuberculosis complex and NTMs
Nontuberculous mycobacteria (NTM) are a ubiquitous group of environmental bacteria that are found for example in water or soil and can occasionally infect humans. In contrast to Mycobacterium tuberculosis and M. leprae, NTM infections are generally harmless and transient and are normally not transmitted from one person to another. However, NTMs can occasionally lead to severe disease, especially in people with compromised immune system or with chronic lung conditions, but also more and more commonly in immunocompetent children and adults. In the last few years, the incidence of nontuberculous mycobacterioses has increased worldwide, particularly in countries with low TB prevalence.
There is no standard therapy regimen for NTM infections. The choice of treatment depends on the respective mycobacteria species that is suspected in causing the disease. Therefore, reliable and rapid NTM species detection is the first step for initiation of an appropriate therapy. Moreover, it is important to differentiate between harmless transient NTM infection and disease-causing established infections, which can be confirmed with monitoring at regular intervals.
Since NTM disease can frequently resemble tuberculosis, it is essential to differentiate NTM infection from M. tuberculosis complex infection to identify or to rule out the more dangerous pathogens. Molecular genetic methods for mycobacteria species differentiation have become the tools of choice in NTM diagnostics thanks to their ability to provide rapid and reliable results compared to time-consuming conventional methods.
The well-established molecular assays GenoType Mycobacterium CM VER 2.0 and GenoType Mycobacterium AS VER 1.0 enable reliable differentiation between of M. tuberculosis complex and NTM species from cultured material. The GenoType Mycobacterium CM VER 2.0 assay detects M. tuberculosis complex and differentiates a wide range of clinically relevant NTM in a single assay – GenoType Mycobacterium AS VER 1.0 complements the diagnostics with additional NTM species from the same sample preparation. Together the two assays cover a comprehensive panel of the most encountered and clinically relevant mycobacteria at species level, empowering doctors with information necessary for making successful therapy decisions.
GenoType Mycobacterium CM VER 2.0
GenoType Mycobacterium CM VER 2.0 enables fast and reliable detection of the M. tuberculosis complex and clinically relevant NTM from cultivated samples. The most commonly encountered pathogenic species, such as M. avium, M. abscessus and M. kansasii, as well as the relatively harmless but highly prevalent M. gordonae, can be identified among more than 20 species in a single assay. The assay follows the familiar line probe assay workflow, with the DNA extraction, amplification and hybridisation steps in a highly multiplexed approach. An Internal Control (IC) serves as an extraction and amplification control and indicates a correct processing. The Genus Control (GC) shows whether members of the genus Mycobacterium are present, thereby enabling reporting of NTMs even when the specific species cannot be identified and prompting further complementary testing with the GenoType Mycobacterium AS VER 1.0 assay.
GenoType Mycobacterium AS VER 1.0
GenoType Mycobacterium AS VER 1.0 enables fast and reliable detection of clinically relevant NTM from cultivated samples. The assay is complementary to the GenoType Mycobacterium CM VER 2.0 and allows detection of more than 15 less common clinically important NTMs, such as M. gastri and M. genavense. The two assays can be run in parallel for a fast and comprehensive result, or sequentially, with additional strains tested upon a positive reporting of the genus Mycobacterium and absence of the common NTM species or M. tuberculosis complex. A second DNA extraction and amplification is not necessary for GenoType Mycobacterium AS VER 1.0, since the DNA amplicon generated with GenoType Mycobacterium CM VER 2.0 can be used for testing.
This workflow enables a robust and sensitive NTM detection and differentiation and thereby allows initiation of an effective therapy.
* For illustrative purposes only. For result interpretation, please refer to Instructions for Use
Enabled by DNA•STRIP technology
The well-proven DNA•STRIP technology is based on PCR and reverse hybridization. It enables highly efficient diagnostics for all throughputs with low implementation costs. All DNA•STRIP products can be combined with each other. This permits joint execution of several human-genetic and microbiological diagnostic parameters.
Convenient and low-cost implementation in diagnostic routine
Both assays can be carried out without high-budget investments. This enables low-cost implementation for every laboratory size. DNA extraction is performed manually with GenoLyse® VER 1.0. The subsequent PCR reaction can be performed in a standard thermal cycler. A convenient workflow is enabled by the GTQ-Cycler 96 as 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 fully automated with the GT-Blot 48 or partially automated with the TwinCubator.
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
