CerTest Launches VIASURE SARS-CoV-2 Variant II Real Time PCR Detection Kit

CerTest Biotec (Zaragoza, Spain) has launched VIASURE SARS-CoV-2 Variant II Real Time PCR Detection Kit, a real-time RT-PCR test designed for the qualitative detection of RNA from genetic mutations in the S gene (P681R, L452R and E484Q) from positive SARS-CoV-2 nasopharyngeal samples.

The appearance of genetic mutations is a natural and expected event within the evolution process of a virus. In fact, some specific mutations define the viral genetic groups currently circulating globally. Besides, thanks to the genetic sequencing of the pathogen worldwide, it has been possible to establish patterns of dispersal and evolution of the virus. All viruses, including SARS-CoV-2, mutate over time. Some changes may affect the virus’s properties, such as how easily it spreads, the associated disease severity, or the performance of vaccines, therapeutic medicines, diagnostic tools, or other public health and social measures.

At the end of 2020, the appearance of variants with a higher risk 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, Kappa and Epsilon. Delta (B.1.617.2 lineage) and Kappa (B.1.617.1 lineage) 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. Epsilon variant, first detected in California, USA, consists of two distinct lineages B.1.427 and B.1.429 in clade 20C. This variant has multiple mutations in the spike protein, including L452R. An estimated increase in transmission rate of the B.1.427/B.1.429 lineages related to circulating non- B.1.427/B.1.429 lineages was 20%.

All these variants described above show potential reduction in neutralization by some
immunotherapies and reduction of expected effects of vaccines or has been identified to cause community transmission. That is why, their appearance constitute a first-order public health problem that can have an important impact on control of the pandemic. A concern regarding the new variants is that their detection by molecular techniques (RT-PCR) could be affected.

For this reason, VIASURE SARS-CoV-2 Variant II Real Time PCR Detection Kit has been designed to allow the detection of the main mutation associated with the variant under surveillance. The test is intended for use as an aid to monitor the prevalence of genetic mutations in the S gene (P681R, L452R and E484Q) and to assist in control measures. RNA is extracted from respiratory specimens, complementary DNA (cDNA) is synthesized and amplified using RT-qPCR and detected using fluorescent reporter dye probes specific for genetic mutations in the S gene (P681R, L452R and E484Q).