Product Category

HPV GenoArray Diagnostic Kit

  • The 21 HPV GenoArray Diagnostic Kit is a qualitative PCR based in vitro diagnostic test for identification of 21 HPV genotyping in cervical specimens. The assay is optimized to detect 15 high-risk HPV and 6 low-risk HPV.
  • By using polymerase chain reaction (PCR) to amplify extracted HPV DNA from cervical samples, amplified DNA amplicons are hybridized with specific HPV probes located inside the “Hybrimem” under our US patented “flow-through hybridization” technology, results are obtained by colorimetric result using enzyme immunoassay method.

สอบถามข้อมูล สั่งซื้อสินค้า

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Features

  • Detection of 21 HPV genotypes in one single reaction
  • CE-IVD marked and MNPA registered
  • WHO HPV LabNet Proficiency Test validated (2011, 2013, 2015&2017)
  • The ONLY HPV assay appointed by the Cervical Cancer Prevention Program in China (Over three million tests performed in 2019)
  • High clinical sensitivity and clinical specificity: >95% (compared to FDA approved kit)
  • Promising results compared to Roche’s Linear Array; with a better detection of HPV 52
  • Include amplification control (IC) and hybridization control (Biotin) for monitoring of the entire experimental process

 

Specimens

  • Cervical swab
  • Liquid based cytology specimen (e.g. Thinprep, Surepath, Roche Female Swab Sample Kit, Hybribio Female Sample Collection Kit)
  • Urine
  • Exfoliated skin cells using sandpaper around genital area (Male)
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