SARS-CoV-2 (II) (genes ORF1ab and N) lyophilised RTU qPCR CE/IVD

Intended Use

Vitassay qPCR SARS-CoV-2 allows the qualitative detection of SARS-CoV-2 by real-time RT-PCR in respiratory samples (nasopharyngeal and oropharyngeal swabs) and saliva samples. The product is intended for use in SARS-CoV-2 infections diagnosis 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 Plate containg lyophilised target primer, polymerase (and reverse transciptase) and nucleotides
- SARS-CoV-2 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: 12x8 cap strip

Kit Format: qualitative