INFINITI HPV Genotyping Assay

  • The INFINITI HPV Genotyping Assay is CE Marked.
  • The INFINITI HPV Genotyping is designed to detect 26 human papillomaviruses.
  • The INFINITI HPV Genotyping utilizes the HPV Genotyping Intellipac, HPV Genotyping Amp Mix and HPV Genotyping BioFilmChip Microarray.
  • The INFINITI HPV Genotyping Assay can be automated by the INFINITI Analyzer.
Analytes Detected: 

HPV types: 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 67, 68, 69, 73, 82, 6, 11, 30, 34, 70, 85

Features: 
  • Multiplexed determination of 26 human papillomaviruses with a single sample.
  • Customized reports
  • Load & Go automated on the INFINITI/INFINITI PLUS Analyzer.
  • Replicate determinations on a single BioFilmChip Microarray ensures quality results.
Sample Type and Volume: 
  • Uses endocervical and cervical specimens.
  • Requires 50 ng DNA / reaction.
Clinical Relevance: 
  • Over 100 HPV types have been identified.
  • 14 genotypes are considered High-Risk (HR) for their strong association with cervical cancer.
  • The absolute risk of developing a cellular abnormality after High-Risk HPV infection varies across ethnicities.
Clinical Utility: 
  • Genotyping offers superior Sensitivity and Specificity over that of conventional screening.
  • Type 16 & 18 behave differently than other HR types.
  • Discrimination between persistent and new infection requires knowledge of genotype.
  • Following persistent type specific infections is a central part of management.
  • HPV DNA testing should be used as a follow up test for:
  •       Women with ASCUS/LSIL pap
  •       Women with CIN1 or negative colposcopy but prior ASC-US or LSIL
  •       After treatment for CIN2 and CIN3
  • Co-testing of HPV DNA along with cytology for women over 30 is recommended.
References: 
  1. Dunne, et al. – JAMA; MMWR Weekly – Center for Disease Control and Prevention
  2. Insinga, et al. – Cancer Epidemiol Biomarkers Prev., 2009
  3. Lazo, et al – Brit J Cancer 1999 80(12):2008-18
  4. Corden, et al – Mol Pathol. 1999 52(5): 275-82
  5. Rush, et al – J Virol. 2005 79(18):12002-15
  6. ACOG Practice Bulletin #109
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HPV Genotyping