RUO SARS-CoV-2 + VoC

This test is currently available as a Research Use Only -product.

The increased incidence of COVID-19 cases caused by the SARS-CoV-2 variants has raised concerns worldwide. Monitoring the incidence of new variant strains, especially the variants of concern associated with increased transmissibility and virulence, is essential for infection management. Early detection enables rapid start of infection control and contact tracing, reducing further transmission of the virus.

The GenomEra SARS-CoV-2 + Variants of Concern (VoC) Assay is a rapid and simple multiplex RT-qPCR test intended to be used for SARS-CoV-2 epidemiological research and screening of positive samples to determine the need for genome sequencing. In addition to detecting all SARS-CoV-2 strains, the test indicates the presence of clinically significant deletions and mutations present in the variants of concern. The targets include:

  • The RdRP gene, which is specific to all SARS-CoV-2 strains
  • The Spike-protein 69/70 and the ORF1a 3675-3677 deletions, which are (in different combinations) specific to SARS-CoV-2 variant strains first identified in the UK (B.1.1.7), South Africa (B.1.351), and Brazil (P.1)

RESULT INTERPRETATION

RdRPSpike 69/70 delORF1a 3675-3677 del
Potentially B.1.1.7 (UK variant)                POSPOSPOS
Potentially B.1.351 (South African variant) or P.1 (Brazilian variant)POSNEGPOS
B.1.1, B.1.1.70, B.1.258POSPOSNEG
Other lineages (Incl. Wuhan type)POSNEGNEG

The assay protocol is simple, and no RNA extraction, prior PCR expertise, or dedicated PCR facilities are required. The GenomEra Test Chips contain all the reagents needed for the RT-qPCR and the results are automatically reported by the GenomEra software. Suitable sample materials include respiratory swab samples as well as samples of extracted SARS-CoV-2 positive RNA.

Assay procedure for respiratory swab samples

1. Vortex the original sample for
5 seconds. Pipette 50 μl of the specimen into the bottom of the GenomEra® Resp SPC tube
2. Close the sample tube and heat the sample for 5 minutes at 90 °C 3. Empty the contents of the 1 ml Buffer Ampoule into the sample tube 4. Vortex the sample briefly, pipette 35 μl of the sample to the Test Chip and start the assay