The GenomEra® SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit is a rapid in vitro diagnostic (IVD) test for simultaneous, qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B, and respiratory syncytial virus (RSV) nucleic acids. The assay utilizes multiplex real-time reverse transcriptase polymerase chain reaction (rRT-PCR) to amplify viral RNA on the GenomEra CDX system from upper respiratory tract specimens collected from patients who meet clinical and/or epidemiological criteria for coronavirus disease 2019 (COVID-19), influenza, or RSV.
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, Flu A/B + RSV 2.0 Assay Kit utilizes real-time RT-PCR and hydrolysis probes to detect unique sequence regions of SARS-CoV-2 RNA-dependent RNA polymerase (RdRP), influenza A matrix (M), influenza B hemagglutinin (HA), and RSV nucleocapsid (N) protein encoding genes. The assay protocol takes approximately 50 minutes and ends with the reporting of results.
Available in 20 and 100 test kit sizes.