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Human Papillomavirus (HPV) High Risk by Aptima HPV

Test Code

HPV HR

Associations

Human papillomavirus (HPV) cotesting in conjunction with a PAP smear every 5 years is the preferred method for cervical cancer screening of women age 30-64 by The American Cancer Society (ACS), the American Society for Colposcopy and Cervical Pathology (ASCCP), and the American Society for Clinical Pathology (ASCP). Guidelines also recommend HPV testing for follow-up evaluation in women age 20-30 with ASC-US cytology and HPV genotyping for 16/18 is recomended when HPV is positive and cytology negative.

Methodology

Aptima® HPV: HPV Types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

Turnaround Time

1-3 days

Specimen Requirements

1.0 mL ThinPrep® PAP solution
1.0 mL 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 ambient

Causes for Rejection

Insufficient specimen

Reference Range

HPV detected/not detected

Description

Used to screen women with ASC-US cervical cytology results to determine the need for referral to colposcopy.

To be used adjunctively with cervical cytology to screen women 30 years of age and older to determine the presence or absence of high risk HPV types.

References
  1. American Society for Colposcopy and Cervical Pathology
  2. Castle PE et al (2009). Five-year experience of human papillomavirus DNA and papanicolaou test cotesting. Obstet Gynecol. 113:595-600.
  3. Wright TC Jr et al. (2007). 2006 consensus guidelines for the management of women with abnormal cervical cancer screening tests. Am J Obstet Gynecol. 197:346-355.
  4. Mayrand MH et al. (2007). Human Papillomavirus DNA versus papanicolaou screening tests for cervical cancer. NEMJ. 357:1579-88.
  5. Munoz N et al. (2003). Epidemiologic classification of human papillomavirus types associated with cervical cancer. NEMJ. 348:518.
  6. Solomon D et al. (2001). Comparison of three management strategies for patients with atypical squamous cells of undetermined significance: baseline results from a randomized trial. J Natl Cancer Inst. 93:293–9.
Trademarks

Aptima and ThinPrep are registered trademarks of Hologic

SurePath is a trademark of Becton, Dickinson and Company.