Certest™ VIASURE SARS-CoV-2 Variant – BD MAXTM System Real Time PCR Detection Kit

Certest™ VIASURE SARS-CoV-2 Variant – BD MAXTM System Real Time PCR Detection Kit 

VIASURE SARS-CoV-2 Variant Real Time PCR Detection Kit for BD MAX™ System is an automated real-time RT-PCR test designed for the qualitative detection of HV 69/70 deletion, K417N mutation and K417T mutation in the S gene of SARS-CoV-2, associated to SARS-CoV-2 Alpha (lineage B.1.1.7), Beta (lineage B.1.351) and Gamma (linage P.1) variants, in nasopharyngeal and oropharyngeal swabs and saliva samples.

The assay is intended to be used with SARS-CoV-2 positive samples or, when the test is performed in conjunction with the VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit for BD MAX™ System (Ref: 444215) with samples from patients suspected Coronavirus disease 2019 (COVID-19) by their healthcare professional (HCP).

This test is intended to be used as an aid to monitor the prevalence of variants that carry the HV 69/70 deletion, K417N or K417T mutations in the S gene and to assist in control measures. The assay uses the BD MAX™ System for automated extraction of RNA and subsequent real-time RT-PCR, employing the reagents provided combined with universal reagents and disposables for the BD MAX™ System. RNA is extracted from specimens, and complementary DNA (cDNA) is synthetized and amplified using RT-PCR and detected using fluorescent reporter dye probes specific for HV 69/70 deletion, K417N or K417T mutations.

Contents

• SARS-CoV-2 Variant reaction tube: A mix of enzymes, primers-probes,buffer, dNTPs, stabilizers and internal control in stabilized format, 2 pouches of 12 transparent tubes
• Rehydration Buffer tube: Solution to reconstitute the stabilized product, 1 pouch of 24 transparent tubes