BK (quantitative) lyophilised RTU qPCR CE/IVD

Intended Use:
Vitassay qPCR BK allows the identification and quantitative detection of DNA from BK virus by Real-Time PCR in human clinical samples. This product is intended to aid in the diagnosis of BK virus infections in transplant patients, alongside the patient's clinical data, epidemiological risk factors, and other laboratory tests outcomes. The test can be used to assess the need and monitoring the treatment of the infection in these patients.
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:
- BK strips low/high profile: 4 x 8-well strip
- BK Quantitative standards : 5 vials (1 vial per concentration)
- 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
- For quantitative assay: target specific standard

Kit Format:
qualitative