MTBC-NTM Real Time PCR kit
INTENDED USE
The MTBC-NTM Real Time PCR kit is an in vitro diagnostic kit for the qualitative detection of DNA of Mycobacterium spp., Mycobacterium tuberculosis complex (MTBC) and Mycobacterium tuberculosis species from human pulmonary and extra pulmonary clinical specimens such as sputum, bronchoalveolar lavage, pleural fluid, skin, cerebrospinal fluid and bacterial cultures. It is based on the multiplex real-time PCR technique, using primers and specific fluorescent probes for target genes.
Specific primers and fluorescent probe are included for the simultaneous detection of the human hemoglobin beta gene as internal quality control of the starting and amplification material. The detection channels of the different targets are:
This test must be carried out at hospital level in clinical microbiology laboratories to those patients who show symptoms compatible with Mycobacterium infection. The intended end use is as aid in the diagnosis of this infection in combination with clinical risk and epidemiological factors.
Microbiological status: Non-sterile product.