RevoDx Flu A&B / RSV / SARS-CoV-2 qPCR Kit
Intended Use
RevoDx Flu A&B / RSV / SARS-CoV-2 qPCR Kit is a real-time RT-PCR test intended for the qualitative detection and differentiation of nucleic acid from the Influenza A, Influenza B, Respiratory Syncytial Virus (RSV) and SARS-CoV-2 in human oropharyngeal swab and nasopharyngeal swab specimens from individuals with signs and symptoms of infection who are suspected of Flu or COVID-19.
The Influenza A, Influenza B, RSV and SARS-CoV-2 RNA is generally detectable in human oropharyngeal swab and nasopharyngeal swab specimens during the acute phase of infection. Positive results are indicative of active infection. Laboratories are required to report all positive results for SARS-CoV-2 to the appropriate public health authorities.
Negative results do not preclude 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 Flu A&B / RSV / 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 Flu A&B / RSV / SARS-CoV-2 qPCR Kit is to be used with BIO-RAD CFX96 Real-Time PCR Detection Systems. But the RevoDx Flu A&B / RSV / SARS-CoV-2 qPCR Kit may also be compatible with most real-time PCR detection systems with the channels FAM, HEX, ROX and Cy5.
Features
- Single tube, multiple targets
- Ready-to-use kit
- Human RNase P as an internal control
- CE-IVD marked
- The Limit of Detection (LoD) value is less than 100 copies/mL
- Diagnostic specificity is ≥ 99 %
- No cross-reactivity with the potential cross-reactive markers shown using both in silico analysis and wet testing.
Ordering Information