PHOENIXDX® SARS-COV-2 IVD 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.
PHOENIXDX® SARS-COV-2 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 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).
Download the manual here
Download the declaration of conformity here
Download the ISO 13485 certificate here