VIASURE SARS-CoV-2 Variant II (P681R+L452R) Real Time PCR Detection Kit for BD MAX™ System is an automated real-time RT-PCR test designed for the qualitative detection of P681R mutation and L452R mutation in the S gene RNA from positive SARS-CoV-2 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 P681R or L452R 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 P681R and L452R mutations.
At the end of 2020, the appearance of variants with a higher risk for public health prompted the characterization of Variants of Interest (VOI) and Variants of Concern (VOC), in order to facilitate epidemiological control. Some of these SARS-CoV-2 variants are:
Delta (B.1.617.2 lineage) and Kappa (B.1.617.1 lineage) variants were closely associated with a huge COVID-19 increase in India during Spring 2021. Delta variant has multiple mutations in the Spike protein, including P681R and L452R. Kappa variant has also genetic mutations in the Spike protein, including P681R, L452R and E484Q.
CERTIFICATE OF ANALYSIS