WizDx™ SARS-CoV-2/Flu CrystalMix PCR Kit is a Multiplex real-time RT-PCR test intended for the simultaneous qualitative detection of RNA from the SARS-CoV-2, influenza viruses in the nasopharyngeal swab, oropharyngeal swabs, and sputum from patients.
WizDx™ SARS-CoV-2/Flu CrystalMix PCR Kit combines all the reagents necessary for successful one-step real-time RT-PCR in a convenient individually aliquot and lyophilized in an 8-strip qPCR tube.
MFDS License No. : IVD-22-856
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Target genes | SARS-CoV-2 (RdRp, N gene), 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 | SARS-CoV-2 100%, Influenza A virus 100%, Influenza B virus 100% |
Analytical sensitivity (LOD) | SARS-CoV-2 100 copies/rxn, Influenza A/B virus 100 copies/rxn |
Linear range | SARS-CoV-2/Flu 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 |