RevoDx Direct SARS-CoV-2 qPCR Kit on 96/384-well plate (Extraction-free)

Intended Use

RevoDx Direct 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. 

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. 

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

RevoDx Direct SARS-CoV-2 qPCR Kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. 

Instruments

The RevoDx Direct SARS-CoV-2 qPCR Kit is to be used with BIO-RAD CFX96 Real-Time PCR Detection Systems. But the RevoDx Direct SARS-CoV-2 qPCR Kit may also be compatible with most real-time PCR detection systems with the channels FAM and HEX