RevoDx SARS-CoV-2
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.
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 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 SARS-CoV-2 qPCR Kit is to be used with BIO-RAD CFX96 Real-Time PCR Detection Systems. But the RevoDx SARS-CoV-2 qPCR Kit may also be compatible with most real-time PCR detection systems with the channels FAM and HEX
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 58 copies/mL
- Diagnostic specificity is ≥ 99 %
- No cross-reactivity with the potential cross-reactive markers shown using both in silico analysis and wet testing.