LINEAR ARRAY® HPV Genotyping

Product image for LINEAR ARRAY® HPV Genotyping

Ability to detect HPV DNA and individual types

LINEAR ARRAY® HPV Genotyping Test is a qualitative test that detects 37 high- and low-risk human papillomavirus genotypes, including those considered a significant risk factor for HSIL progression to cervical cancer.

 

Features and benefits

Features
  • Ability to detect HPV DNA of 37 anogenital HPV types
  • Capable of detecting and type-specifically identifying HPV DNA from co-infections, which can occur in up to 35% of patient samples1
  • Linear Array's genotyping performance can be attributed to
    • Standardized, quality-controlled reagents
    • Primer concentrations that minimize competition due to coamplification
  • HPV genotypes include: 6, 11, 16 18, 26, 31333539, 40, 42, 455152, 53, 54, 55, 565859, 61, 62, 64, 66, 67, 68, 69, 70, 71, 72, 73 (MM9), 81, 82 (MM4), 83 (MM7), 84 (MM8), IS39, and CP6108 (high-risk in bold)  

 

 

Benefits
  • Helps identify women at risk
  • Helps further stratify women with normal cytology who are HPV positive into different risk categories2

 

 

Intended use

This test is a qualitative in vitro test for the detection of Human Papilloma Virus in clinical specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization and detects thirty seven anogenital HPV DNA genotypes [6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 45, 51, 52, 53, 54, 55, 56, 58, 59, 61, 62, 64, 66, 67, 68, 69, 70, 71, 72, 73 (MM9), 81, 82 (MM4), 83 (MM7), 84 (MM8), IS39 and CP6108] in cervical cells collected in PreservCyt® Solution.

Not available in the United States

Registration status

Canada-IVD, CE-IVD

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.

References

  1. van Hamont D, et al. Evaluation of the SPF10-INNO LiPA human papillomavirus (HPV) genotyping test and the roche linear array HPV genotyping test. J Clin Microbiol. 2006;44(9):3122-3129.
  2. Coutlée F, et al. Enhanced detection and typing of human papillomavirus (HPV) DNA in anogenital samples with PGMY primers and the Linear array HPV genotyping test. J Clin Microbiol. 2006;44(6):1998-2006.