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Human Papillomavirus (HPV) Genotyping

Test Code

HPV G

Associations

In 2013 Hologic's APTIMA® HPV 16 18/45 genotype assay was FDA‐approved for genotyping human papillomavirus (HPV) types 16, 18 and/or 45. HPV genotype 45 is the third most common HPV genotype in invasive cancer. The addition of HPV genotype 45 is designed to help identify more women at risk for adenocarcinoma, with minimal impact to colposcopy rates.  Based on a clinical evaluation of more than 10,000 U.S. women with normal cytology results, the APTIMA HPV Assay has 24% fewer false positives than an FDA approved DNA test, thus targeting the right patients for colposcopy and minimizing the potential for harm.

Methodology

Hologic Aptima HPV 16, 18/45 genotype assay

Turnaround Time

3-5 days

Specimen Requirements

2.0 mL liquid cytology media (ThinPrep® PAP solution or SurePath™ Test Pack solution)

Specimen Stability
ThinPrep/SurePath - 30 days from collection at 18-25°C. Specimens are kept for 21 days after receipt
Storage & Handling

Ship at ambient

Causes for Rejection

Insufficient specimen; Low sample cellularity

Reference Range

HPV HR type 16, 18/45 or 16/18/45 Detected/Not Detected

Description

To be used adjunctively, with an FDA approved HPV high risk test, in patients with either a HPV HR+ ASC-US result or, in women 30 years of age and older, with a HPV HR+ primary screening result.

References
  1. American Society for Colposcopy and Cervical Pathology
  2. Meijer CJ et al. (2006). Clinical utility of HPV genotyping. Gynecol Oncol. 103:12-17.
  3. Khan MJ et al. (2005). The 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. JNCI. 97:1072-1079.
  4. Munoz N et al. (2003). Epidemiologic classification of human papillomavirus types associated with cervical cancer. NEJM. 348:518-527.
Trademarks

Hologic, Aptima and ThinPrep are registered trademark of Hologic Inc.

SurePath is a trademark of Becton, Dickinson and Company.