WizDx™ Influenza A/B CrystalMix PCR Kit is intended to be used to achieve qualitative detection of Influenza A/B viral RNA extraction from nasopharyngeal swabs, oropharyngeal swabs, and sputum from patients.
MFDS License No. : IVD-21-300
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Target genes |
Influenza A (matrix gene), Influenza B (HA gene)
|
Internal control |
Human beta-actin gene
|
Positive control | Included |
Turnaround time | < 40 minutes from extracted RNA to end results (using CLEO™ Q16) |
Validated sample type | Sputum, oropharyngeal swab, and nasopharyngeal swab samples |
Technology | Real-time PCR |
Type of analysis | Qualitative |
Analytical specificity | Influenza A virus 100%, Influenza B virus 100% |
Analytical sensitivity (LOD) | Influenza A virus 79.6 copy/rxn, Influenza B virus 81.7 copy/rxn |
Linear range | Influenza A/B 1x105 ~ 1x102 copy/rxn with precision ± 0.5 log |
Reagent form | Freeze-dried, corn shape |
Compatible real-time PCR instruments | Bio-Rad CFX96, ABI QuantiStudio, Wizbiosolutions CLEO™ Q16 |