Phoenix DX SARS-CoV-2 Multiplex IVD qPCR Kit

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PHOENIX DX SARS-COV-2 MULTIPLEX IVD, 50 Preps is a real-time RT-PCR-based diagnostic test for the in vitro qualitative detection of 2019-Novel Coronavirus (SARS-CoV-2) in respiratory specimens and sera from patients who meet COVID-19 clinical and/or epidemiological criteria. 

PHOENIX DX SARS-COV-2 MULTIPLEX IVD detects  SARS-CoV-2  RNA  in nasopharyngeal and oropharyngeal swab samples during infection. Positive results indicate the presence of SARS- CoV-2 RNA; clinical correlation with patient history and other diagnostic information must be considered to determine the actual patient infection status. Positive results do not exclude bacterial infection or co-infection with other viruses. 
Negative results do not exclude a SARS-CoV-2 infection and must not be used as the sole basis for patient management decisions.  Negative results must be combined with clinical observations, patient history, and epidemiological information. 
The use of PHOENIXDX® SARS-COV-2 MULTIPLEX IVD is intended for use by clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. 
The kits follow CDC’s and WHO’s latest detection guidelines (03/2020). 

PHOENIX DX SARS-COV-2 MULTIPLEX IVD is a real-time RT-PCR-based detection system for the 2019 Wuhan coronavirus (SARS-CoV-2, formerly 2019-nCoV). SARS-CoV-2 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.