MTB complex RTU lyophilised qPCR CE/IVD

Intended Use

Vitassay qPCR MTB complex allows the qualitative detection and identification of DNA from Mycobacterium tuberculosis complex species in respiratory samples. This product is intended to aid in the diagnosis of Mycobacterium tuberculosis complex species infections, alongside the patient’s clinical data, epidemiological risk factors, and other laboratory tests outcomes.

Vitassay qPCR Kits contains in each well enzymes, buffer, primer and probes as well as an internal control in a lyophilized format.
The kits include a positive and a negative control.

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:
- MTB complex strips low/high profile
- MTB complex Positive Control (red vial): 1 vial
- PCR grade water (white vial): 1 vial
- Resuspension Buffer (green vial): 1 vial x1,8 mL
- Negative control (yellow):1 vial x 1 mL
- Optical caps: 4x8 cap strip

Kit Format: qualitative