COVID-19 genesig® Real-Time PCR assay is an in vitro diagnostic test based on Real-Time PCR technology, developed for specific detection of SARS-CoV-2 viral RNA. The probe system is based on the standard hydrolysis probe system known as TaqMan® Technology. The SARS-CoV-2 specific probe is labelled with the FAM fluorophore and the internal control (which is from non-biologically relevant exogenous source) is labelled with the HEX fluorophore.

The oligonucleotide primers and probe for the detection of SARS-CoV-2 were selected from the orf1 ab genome region. The supplied primer/probe mix is designed for the specific detection of SARS-CoV-2 RNA (probe labelled with FAM fluorophore) and the supplied genesig® Easy RNA Internal Extraction control (IEC specific probe is labelled with HEX fluorophore).

COVID-19 genesig® Real-Time PCR assay includes an internal extraction control (Genesig® Easy RNA Internal Extraction control), which is added to the IVD nucleic acid extraction system (not provided) to measure RNA extraction purity, detect PCR inhibition and confirm the integrity of the PCR run.

COVID-19 genesig® Real-Time PCR assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

Refer to the Centers for Disease Control and Prevention (CDC) guidelines:
Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with SARS-CoV-2