High-Risk HPV lyphilized RTU qPCR CE/IVD

Intended Use:
Vitassay qPCR High-Risk HPVs allows the simultaneous qualitative detection of genomic DNA specific for 14 high risk Human papillomavirus (HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) and the two main HPVs identification, HPV 16, and HPV 18, in cervical samples (liquid base solution for cytology) of patients suspected of high-risk HPV infection. This product is intended to aid in the diagnosis of high-risk HPV infections, as well as the HPV types 16 and 18 identification, alongside the patient’s clinical data 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:
- High-Risk HPVs 1 strips low/high profile: 4 x 8-well strip
- High-Risk HPVs 2 strips low/high profile: 4 x 8-well strip
- High-Risk HPVs PositiveControl (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