LINEAR ARRAY® HPV Genotyping Test

Ability to detect HPV DNA and individual types

Persistent HPV infection with specific high-risk HPV types is an indicator of high grade lesions (HSIL).1 HPV genotyping assays, may be used in cytology negative, HR-HPV-positive women over 30 in the same manner as HPV triage testing is currently utilized in women with ASC-US or BMD cytology.2

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 and individual types
  • Capable of detecting HPV genotypes present in a multiple infection, which can occur in up to 35% of patient samples3
  • Ability to detect HPV DNA and individual types may be attributed to the use of4:
    • Standardized, quality-controlled reagents
    • Primer concentrations that minimize competition due to coamplification
  • HPV genotypes include: 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 (high-risk in bold)

Benefits

  • Helps identify women at risk and optimize treatment strategies
  • Helps further stratify women with normal cytology who are HPV positive into different risk categories5
  • Identifying infection with HPV Type 16 and Type 18 among these women justifies immediate colposcopy6
  • Women with other HR-HPV infections at lower risk can be managed less aggressively6
  • Provides physicians with actionable information to treat the highest risk patients immediately7

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

References

  1. Susanne K Kjaer, Type specific persistence of high risk human papillomavirus (HPV) as indicator of high grade cervical squamous intraepithelial lesions in young women: population based prospective follow up study. BMJ. 2002;325(7364):572.
  2. Wright TC, et al. 2006 consensus guidelines for the management of women with abnormal cervical cancer screening tests. AM J Obstet Gynecol 2006;197(4):346-355.
  3. 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.
  4. 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.
  5. Meijer CJ, Snijders PJ, Castle PE. Clinical utility of HPV genotyping. Gynecol Oncol. 2006;103:12-17.
  6. Khan MJ, Castle PE, Lorincz AT, et al. Elevated 10-year risk of cervical precancer and cancer in women with human papillomavirus (HPV) type 16 or 18 and the possible utility of type-specific HPV testing in clinical practice. J Natl Cancer Inst. 2005;97:1072-1079.
  7. Wright TC Jr, Massad LS, Dunton CJ, et al. 2006 consensus guidelines for the management of women with abnormal cervical cancer screening tests. Am J Obstet Gynecol. 2007;197:346-355.