PHOENIXDX® SARS-CoV-2 Multiplex IVD is a real-time RT-PCR-based detection system for the 2019 Human coronavirus (SARS-CoV-2). It is considered a novel human coronavirus that is genetically distinct from the common human coronaviruses (229E, NL63, OC43, HKU1), which cause seasonal acute respiratory illness. It is also genetically distinct from the two newer human coronaviruses, MERS-CoV and SARS-CoV.
PHOENIXDX® detects the presence of different and highly specific gene sequences of the novel Human Coronavirus. Additionally, a non-infectious positive control is included. The positive control is used to confirm functionality of the assays and overall PCR performance, the negative human extraction control assay is included to evaluate the quality of the RNA isolation independently from the 2019-nCoV assays.
Links to the FDA EUA for Multiplex
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