WizDx™ CrystalMix HPV 16/18 kit is an in vitro diagnostic Multiplex real-time PCR test for the qualitative detection of DNAs from Human Papillomavirus type 16 and 18 in cervical, vaginal, and genital specimens of patients.
MFDS License No. : IVD-23-555
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Target genes | HPV 16/18 |
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 | Cervical, Vaginal, and Genital specimen |
Technology | Real-time PCR |
Type of analysis | Qualitative |
Analytical specificity | HPV 16 100%, HPV 18 100% |
Analytical sensitivity (LOD) | HPV 16 0.5 copy/uL, HPV 18 0.5 copy/uL, |
Reagent form | Freeze-dried, corn shape |
Compatible real-time PCR instruments | CLEO™ Q16, Bio-Rad CFX96, ABI QuantiStudio 5 |