GenoType CMdirect VER 1.0
Molecular assay for direct detection of M. tuberculosis complex and differentiation of clinically relevant nontuberculous mycobacteria
Direct detection and differentiation of the M. tuberculosis complex and NTMs
Nontuberculous mycobacteria (NTM) are a ubiquitous group of bacteria found in the environment including water and soil and capable of causing infections in humans. In contrast to Mycobacterium tuberculosis and M. leprae, NTM infections are generally harmless and transient. However, they can cause severe disease, especially in immunocompromised patients or people with chronic lung conditions, and 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 and therefore the choice of treatment depends on the respective mycobacteria species that is suspected of causing the disease. Thus, reliable and rapid NTM species detection is the first step for initiation of a relevant therapy.
Directly starting from the patient specimen circumvents culturing steps, saves time and enables an early start of an appropriate therapy. Molecular genetic methods for mycobacteria species differentiation have become the tools of choice in NTM diagnostics providing rapid and reliable results compared to time-consuming conventional methods.
GenoType CMdirect VER 1.0 enables rapid and reliable differentiation of M. tuberculosis complex and NTM species directly from decontaminated sputum samples. The assay detects and differentiates a variety of clinically relevant NTM in a single assay. With results attainable within just 5 hours, GenoType CMdirect VER 1.0 is a powerful tool for successful therapy decisions.
GenoType CMdirect VER 1.0
GenoType CMdirect VER 1.0 enables fast and reliable detection of the M. tuberculosis complex and clinically relevant NTM directly from sputum samples sidestepping the culturing requirements. The most common 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 in a highly multiplexed approach. An Internal Control (IC) serves as an extraction and amplification control and monitors the complete process from DNA extraction to result. The Genus Control (GC) indicates that members of the genus Mycobacterium are present in the sample and thereby enabling reporting of NTMs even when the specific species cannot be identified.
For illustrative purposes only. For result interpretation, please refer to Instructions for Use.
Enabled by DNA•STRIP technology
The well-known DNA•STRIP technology is based on multiplex PCR and subsequent reverse hybridization. The technology and corresponding workflow enables efficient diagnostics for high and low throughput with minimal implementation costs. All DNA•STRIP products can be run with each other and therefore permit combined processing of several human-genetic and microbiological diagnostic parameters.
Convenient and affordable implementation in mycobacteria routine
GenoType CMdirect VER 1.0 can be implemented without high-budget investments and therefore fits every laboratory size. DNA extraction is done manually in few steps with GenoLyse® VER 1.0. The following PCR reaction can be done 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 all 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
