The GenomEra® SARS-CoV-2 2.0 Assay Kit is a rapid in vitro diagnostic (IVD) test for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid. The assay utilizes RT-PCR to amplify SARS-CoV-2 viral RNA on the GenomEra® CDX system from respiratory swab samples from patients who meet coronavirus disease 2019 (COVID-19) clinical and/or epidemiological testing criteria.
The assay is compatible with a wide range of commercial sample collection media available, including inactivating media. The respiratory swab specimens are collected and stored in viral transport medium, preferably eNAT (Copan, Italy). Swab specimens collected in any other collection medium than eNAT are diluted in 1:1 ratio with eNAT for sample lysis.
The GenomEra SARS-CoV-2 2.0 Assay Kit utilizes real-time RT-PCR and hydrolysis probes to detect unique sequence regions of SARS-CoV-2 envelope (E) and RNA-dependent RNA polymerase (RdRP) protein-coding genes. The assay protocol takes approximately 50 minutes and ends with the reporting of results.
Available in 20 and 100 test kit sizes.
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