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MOLECULAR DIAGNOSTIC KITS

RADI Human Papillomavirus Detection KIT(REF: RS002)

Introduction

The RADI Human Papillomavirus Detection KIT is an in vitro diagnostic medical device,
based on Real-time RT-PCR technology to screen the HPV DNA.

Product Specification

  • RADI Human Papillomavirus Detection KIT (REF: RS002)
    Intended use Qualitative screening of nucleic acid extracted from the 2 High risk HPV 16 (HEX) and HPV18 (ROX) and the other comparative low risk genotypes (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68-FAM)
    Specimen type Urine, Vaginal Swab
    Target HPV16 and/0r HPV18 and/or HPC others
    Product contents HPV Primer & Probe mixture
    2X RADI MasterMix
    HPV Positive control
    RNase free water
    LoD (copies/㎕) Urine: : 575.44 copies (HPV16), 446.68 copies (HPV18), 371.19~1000 copies (HPV others)
    Vaginal Swab: 645.65 copies (HPV16), 588.84 copies (HPV18), 331.13~1230.27 copies (HPV others)
    Storage
    condition
    -25 ℃ ~ -15 ℃

Test Procedure

  • Nucleic acid
    extraction
  • Make Mixture

    * Simplified Procedure when make mixture
    (Number of tubes minimized)!

  • Real-time
    PCR Run
    CFX96(BioRad)
    ABI7500(ThermoFisher)
    Rotor-Gene Q (Qiagen)
    LightCycler 480(Roche)
  • Analysis

Test Performance