SARS-CoV-2 + UK Variant (S gene deletion HV 69/70 deletion) RTU qPCR CE/IVD

Intended Use

Vitassay qPCR SARS-CoV-2 + UK Variant allows the qualitative detection of SARS-CoV-2 and the HV 69/70 deletion of the S gene for SARS-CoV-2 associated to the SARS-CoV-2 VOC-202012/01 (lineage B.1.1.7) variant and other variants by real-time RT-PCR in nasopharyngeal swabs. The product is intended for use in the diagnosis of SARS-CoV-2 and variants that carry the HV 69/70 deletion infections 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:
- SARS-CoV-2 + UK Variant Plate
- SARS-CoV-2 + UK Variant Positive Control : 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: 12x8 cap strip

Kit Format: qualitative