MTBC/NTM RTU lyophilized qPCR CE/IVD

Intended Use
Vitassay qPCR MTBC/NTM allows the detection and differentiation of the M. tuberculosis complex (MTBC), the genus mycobacterium, and the specie M. tuberculosis by real-time PCR in clinical samples. The product is intended for use in the diagnosis of the M. tuberculosis complex (MTBC), the genus mycobacterium, and the specie M. tuberculosis infections alongside clinical data of the patient and other laboratory tests outcomes.

Identification of pathogen DNA or RNA occurs by the use of target specific primers ans fluorecent labeled hydrolysis probes which hybridize conserved regions in the genomes of the different pathogens.

Kit Content:
- MTBC/NTM strips low/high profile
- MTBC/NTM Positive Control: 1 vial
- PCR grade water (white vial): 1 vial
- Resuspension Buffer (green vial): 1 vial x1 mL
- Negative control (yellow):1 vial x 1 mL
- Optical caps: 4x8 cap strip
- For quantitative assay: target specific standard

Kit Format: qualitative