VIASURE SARS-CoV-2 & UK Variant (S UK, ORF1ab and N genes) Real-Time PCR Detection Kit

VIASURE SARS-CoV-2 & UK Variant (S UK, ORF1ab and N genes) Real-time PCR kit is designed for qualitative detection of RNA from SARS-CoV-2 and HV 69/70 deletion of the S gene of SARS-CoV- 2, associated with VOC variant 202012/01 (line B.1.1.7) as well as other SARS-CoV-2 variants. Detection is performed in nasopharyngeal, oropharyngeal and nasal samples, nasopharyngeal aspirates and bronchoalveolar lavage from persons with suspected infection. This test is intended to be used as an aid in the diagnosis of SARS-CoV-2, as well as other variants that carry the HV 69/70 deletion. RNA was extracted from respiratory samples, amplified by RT-PCR, and detected using fluorescent reporter dyes specific for the ORF1ab and N genes, as well as the HV 69/70 deletion. Detection of ORF1ab is performed in the ROX channel, of the N gene in the Cy5 channel, and the deletion of HV 69/70 of the S gene in FAM . Included in the analysis is internal endogenous control, which is detected in the HEX channel. ANALYTICAL SENSITIVITY VIASURE SARS-CoV-2 & UK Variant (S UK, ORF1ab and N genes) Real Time PCR Detection Kit has a detection limit of 40 genomic copies/reaction for S gene (HV 69/70 deletion), 40 genomic copies/reaction for ORF1ab and 80 genomic copies/reaction for N gene. CE-IVD marked