GenoType Mycobacterium AS - NTM identification PCR CE/IVD

Within the genus Mycobacterium it can be distinguished between the tuberculosis pathogens and non-tuberculosis pathogens (NTM, Non-Tuberculous Mycobacteria). In view of the varying pathogenicity and apathogenicity of some species a fast and certain differentiation is most essential. From a medical point of view it is indispensable to make a clear and safe distinction between the Mycobacterium tuberculosis complex and NTM and to apply adequate therapies and appropriate quarantine measures when tuberculosis pathogens have been detected. A late diagnosis and thus a delay in the beginning of appropriate treatment is detrimental to the success of the treatment and aids transmission of the disease.
Non-tuberculous mycobacteria can cause chronic mycobacterioses. Infectiousness and symptoms vary in a broad range and depend both on the pathogen as well as on the immunocompetence of the person affected. Immunocompromised persons such as HIV or leukaemia patients are most likely to develop a severe mycobacteriosis. Especially in high prevalence countries with elevated numbers of HIV patients, this is a serious threat and requires rapid and appropriate treatment of atypical mycobacterioses. Consequently the clinical significance of the NTM group members also has to be determined in order to avoid under- or over treatment. In the interest of the patients, time-consuming biochemical analyses should be replaced by fast and exact molecular genetic diagnostics.

The GenoType Mycobacterium CM and the GenoType Mycobacterium AS give you the possibility to diagnose patients with a positive culture result for mycoabacterial growth. If the patient is therefore suspected to suffer from a tuberculosis or mycobacteriosis the identification of the particular species will help to decide on an appropriate treatment.

The GenoType Mycobacterium CM and the GenoType Mycobacterium AS are two test systems that can be purchased separately although both tests have the same starting material (solid or liquid culture) and the hybridization can be performed with the same PCR product.

The GenoType Mycobacterium CM permits the simultaneous molecular genetic identification of

- the M. tuberculosis complex
- and 24 of the most common NTM species

while the GenoType Mycobacterium AS permits the simultaneous molecular genetic identification of 19 additional NTM species.

Your benefits with GenoType Mycobacterium CM/AS

- Can be performed from solid or liquid culture samples.
- With one PCR but two subsequent hybridizations the detection and differentiation of M. tuberculosis complex and 40 clinically relevant NTM species is possible.
- Allows the detection of even weak-positive cultures and mixed cultures from fast- and slow-growing mycabacteria.
- Results are obtained within 5 hrs compared to several weeks with conventional methods.

Molecular genetic assays for identification and differentiation of M. tuberculosis complex and 40 most common NTM

Starting material:
liquid and/or solid culture samples

DNA Isolation:
GenoLyse® or other methods producing amplifiable DNA from bacteria (for example QIAamp DNA Mini Kit from Qiagen).

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