RevoDx SARS-CoV-2 qPCR Kit
Coronaviruses are a large family of RNA viruses including HCoV-229E, OC43, NL63, and HKU1 that usually cause mild respiratory illnesses (1) with the exceptions of the fatal Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) (2) and Middle East Respiratory Syndrome Coronavirus (MERS) (3) of the last two decades. A recent outbreak of pneumonia in Wuhan, China declared in December 12th 2019 led to the isolation and identification of a new human coronavirus, 2019-nCoV (SARS-CoV-2), as the responsible agent of this new acute respiratory syndrome (4).This virus can cause the disease named coronavirus disease 2019 (COVID-19). WHO refers to the virus as COVID-19 virus in its current documentation.
Intended Use
RevoDx SARS-CoV-2 qPCR Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in respiratory samples such as human oropharyngeal (OP) swab, nasopharyngeal (NP) swab or combined nasopharyngeal (NP) and oropharyngeal (OP) swab from individuals who are suspected of COVID-19 by their healthcare provider
Features
- Single tube, multiple targets
- Ready-to-use kit
- Dual Targets suggested by US CDC and WHO (RdRp and N-genes)
- Human RNase P as an internal control
- CE-IVD marked
- Assay duration: 45 mins
- The Limit of Detection (LoD) value is 55 copies/mL
- Diagnostic specificity is ≥ 99 %
- No cross-reactivity with the potential cross-reactive markers shown using both in silico analysis and wet testing