RevoDx Influenza A&B qPCR Kit
Intended Use
RevoDx Influenza A&B qPCR Kit is a real-time RT-PCR test intended for the qualitative detection and differentiation of nucleic acid from the Influenza A and Influenza B in human oropharyngeal swab and nasopharyngeal swab specimens from individuals with signs and symptoms of infection who are suspected of Flu.
The Influenza A and Influenza B 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.
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 Influenza A&B 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 Influenza A&B qPCR Kit is to be used with BIO-RAD CFX96 Real-Time PCR Detection Systems. But the RevoDx Influenza A&B qPCR Kit may also be compatible with most real-time PCR detection systems with the channels FAM, HEX 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: for Influenza A: 59 copies/mL, for Influenza B: 74 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