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    WizDx™ CrystalMix HPV-HR

    Technical Data Image
    WizDx™ CrystalMix HPV-HR
    WizDx™ CrystalMix HPV-HR kit is an in vitro diagnostic multiplex real-time PCR test for single or simultaneous diagnosis of Human Papillomavirus (HPV) type 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68 for the qualitative detection using vaginal swab or urine specimens from patients. WizDx™ CrystalMix HPV-HR kit combines all reagents necessary for successful Real-time PCR in a convenient individual aliquot and lyophilized in an 8-strip qPCR tube. Real-time PCR technology utilizes polymerase chain reaction (PCR) for the amplification of specific target sequences to detect the L1 gene of Human papillomavirus genotype 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. The probes are labeled with a fluorescent reporter and quencher dyes.
    Catalog Package
    DX1240 96 tests
    • Overview
      • Simultaneous diagnosis of HPV 16, 18, and 12 pooled high-risk HPV
      • Hot-start PCR technology minimizes non-specific PCR reactions and increases specificity.
      • Uracil-DNA glycosylase (UDG) technology prevents carryover contamination.
      • Ready-to-use freeze-dried PCR mix allows convenient storage and a minimal test procedure.
      • Internal cellular control helps prevent false negatives.
      • Using CLEO Q16, the PCR setup can be easily set up with QR code recognition, and test results can be automatically analyzed based on AI, allowing for quick and intuitive confirmation of results.
    • Specifications
      Test Capacity Multiplex Real-time PCR
      Heating / Cooling rate 96 tests/kit
      Operation System Lyophilized (Freeze-dried) in PCR tube
      Detection 5 ag/μL
      Temperature Accuracy Respectively detect the reference specimen of high and low concentrations in different time ranges-10 times, and the precision values of intra-assay and inter-assay Ct values were all <5%.
      Test ID and Sample ID Input • Analytical specificity : 100 % • Clinical Sensitivity : #16 (92.37%), #18 (95.00%), #HR (91.63%) • Clinical Specificity : #16 (99.48%), #18 (99.70%), #HR (96.59%)
      Display Vaginal swab or urine specimens
    • Technical Data
      Technical Image
    • Protocol
      WizDx™ CrystalMix HPV-HR
    • Storage & Shipping
      • Room temperature (4 - 25℃)