HPV lyphilized RTU qPCR CE/IVD

Intended Use:
Vitassay qPCR HPV allows the detection and differentiation of human papilloma virus 16 and 18 by real-time PCR in clinical samples. The product is intended for use in the diagnosis of human papillomavirus 16 and 18 infections alongside clinical data of the patient 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:
- HPV strips low/high profile
- HPV 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
- For quantitative assay: target specific standard

Kit Format:
qualitative