GenoType^® Mycobacteria Direct – Your first result before culture growth!

Approximately 40 years ago the tuberculosis (TB) situation seemed to be under control. Unfortunately, this assumption did not prove right and so TB is still one of the most frequent infectious diseases worldwide. A single patient suffering from active TB may infect up to 15 other individuals every year via airborne transmission. Furthermore, co-infections with HIV and the development of drug resistances of the TB bacilli lead to even higher rates of mortality.
Therefore, to fi ght back against TB it is essential to develop new ways in both, diagnostics and therapy. Especially appropriate diagnostics are an indispensable prerequisite for an effective treatment and to help reduce the spread of the disease.
The GenoType^® Mycobacteria Direct test is based on the NASBA and the DNA•STRIP^® technology. It permits the identification of the following five mycobacteria species: M. avium, M. intracellulare, M. kansasii, M. malmoense and M. tuberculosis complex directly from decontaminated pulmonary and extrapulmonary specimens.

The GenoType^® Mycobacteria Direct test system is a direct test for the evaluation of patients that are suspected of having tuberculosis and who were not treated or treated less than 7 days with tuberculostatics and who did not receive such a treatment within the last 12 months.
The whole procedure is divided into three steps: RNA isolation from decontaminated patient specimens using a "Magnetic Beads Capturing" method, amplification based on the Nucleic Acid Sequence Based Amplification¹⁾ technique (NASBA reaction) and reverse hybridization. This kit contains all the components that are necessary for the various steps.
The GenoType^® Mycobacteria Direct test was not evaluated for monitoring the progression or success of treatment of patients treated with tuberculostatics.

Your benefits with GenoType^® Mycobacteria Direct

• Simultaneous detection and differentiation of the M. tuberculosis complex and the four most important and clinically relevant non-tuberculosis species of mycobacteria.
• Can be performed directly from decontaminated pulmonary and extrapulmonary specimens.
• Isolation of highly specific RNA, i.e. of viable cells, using the “Magnetic Beats Capturing” method.
• Results are obtained within 1 day compared to several weeks with conventional methods.

At a glance
Molecular genetic assay for the direct detection and differentiation fo M. tuberculosis complex and four most clinically relevant Non-Tuberculous Mycobacteria (NTM)

Starting material:
pulmonary and extrapulmonary direct specimens

RNA Isolation:
please refer to the manual

Order number:
24 tests  No. 4010
48 tests  No. 4000