HIGH RISK HUMAN PAPILLOMA VIRUS (HPV) DETECTION
Label Name: HR HPV
Lab Discipline: Molecular Diagnostics
Institution:  Duke University Health System 
EAP ID:  LAB6425 
Last Review:  3/16/2017 2:53:09 PM
Specimen Type
  Cervix
Container & Volume
  Age Group   Container   Volume  
  0  - 21 Years Preservcyt 1  ML
Label Reminders
  Be sure to include patient's name, history #, date and time of collection, and collector's initials.
Collection Notes
  All:
  • Cervical specimens should be collected in PreservCyt® Solution, the ThinPrep® Pap Test preservation system, using a broom-type device (e.g. Rovers Cervex® Brush, Wallach Papette®), or Endocervical Brush/Spatula.

    PreservCyt Solution specimens cannot be frozen.

    There should be at least 1 mL of PreservCyt solution remaining to complete the test.

    ANY SAMPLE SENT WITH LESS THAN 1 mL REMAINING WILL BE REJECTED.


 
Storage
  For Aptima HPV HR testing, cervical specimens can be stored at room temperature(20-30°C) in PreservCyt® Solution for up to 30 days prior to performing the test
Transport
  Cytyc PreservCyt may be shipped at room temperature.
Turn Around Time -  Routine: 7 days   Stat: N/A
Reference Values


HR HPV



No Reference Values
Methodology
  This test uses the FDA-approved in vitro nucleic acid amplification test Aptima HPV assay employing the Panther system (Hologic, Bedford, MA) for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk HPV types including 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.  The Aptima HPV assay does not discriminate between the 14 high-risk types.  For samples with accompanying cytologic evaluation, a minimum of 1 ml of residual PreservCyt solution is required to perform this assay.

http://www.hologic.com/sites/default/files/package%20inserts/AW-10958_002_01.pdf


This assay is cleared for in vitro diagnostic use by the U.S. Food and Drug Administration. In addition, the performance characteristics of this assay have been established by the DUHS Clinical Molecular Diagnostics Laboratory. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA") as qualified to perform high complexity clinical testing. 
   
   
Clinical Significance and Interpretive Data
    Routine screening of cervical cytology (PAP Smears) is the standard of care for the early detection of dysplastic changes that are the precursors to cervical cancer. Early intervention at this precancerous stage can prevent the development of cervical cancer and has lead to a dramatic decrease in the incidence of cervical cancer in the US.

The precursors to cervical cancer, cervical dysplasia, is strongly associated with infection by high risk human papaloma virus (HR HPV). HPV is a highly prevalent papillomavirus that can infect skin and mucous membranes. The HPV types that are associated with cervical dysplasia (6, 11, 16, 18, 31, 33, 35, 39, 42, 43, 44, 45, 51, 52, 56, 58, 59 and 68) infect the epithelial cells of the cervix through sexual contact. Although most infections are self-limiting and do not result in cervical dysplasia, some infections can ultimately lead to cervical cancer.

Assaying for the presence of high risk HPV in conjunction with a Pap smear can assess the risk that a woman has cervical dysplasia. The information gained from HPV testing can be used to guide patient management regarding colposcopy and the frequency of future Pap smear testing. HR HPV testing can also be used as a screening tool in women over 30 years of age and to follow-up on patients with HPV associated dysplastic lesion (see below).

REFERENCES:

1. Wright et. al. (2007) 2006 Consensus guidelines for the management of women with abnormal cervical cancer screening tests. American Journal of Obstetrics and Gynecology. 197: 346-355.

2. Walker et al. (2006) Predicting absolute risk of CIN3 during post-colposcopic follow-up: Results from the ASCUS-LSIL Triage Study (ALTS). American Journal of Obstetrics and Gynocolog. 195: 341-348.

   
Indications
    Data from the ASCUS/LSIL Triage Study (ALTS) sponsored by the National Cancer Institute revealed that high risk HPV testing is a sensitive method to decide which patients with a cytological diagnosis of atypical squamous cells (ASCUS) should be referred for colposcopy. The American Society of Colposcopy and Cervical Pathology has recommended high risk HPV testing over a repeat pap test or immediate colposcopy for the follow-up of patients with ASCUS. HPV testing can also be used for follow up evaluation of post-menopausal women with a cytologic diagnosis of LSIL. HPV high risk testing also may be helpful in the follow-up of patients who have been treated for HPV-associated cervical dysplasia. Finally, HPV testing can be used as an adjunct to cervical cytology for screening women who are 30 years of age or older. For a complete review of the clinical utility of HPV testing, please see the consensus guidelines for the management of women with abnormal cervical cancer screening tests (Wright et. al. American Journal of Obstetrics and Gynecology. 2007; 197(4): 346-355 and Solomon, et al Archives of Pathology Laboratory Medicine. 2009; 133(8):1276-1277).

   
Related Tests
    HUMAN PAPILLOMA VIRUS (HPV) TYPE 16 AND 18 DNA DETECTIO
   
Test Synonyms
  Synonym(s): High Risk HPV
Synonym(s): HPV
Synonym(s): PAP
Molecular Diagnostics Laboratory
(MDX)

Medical Director:
 Michael Datto, M.D., Ph.D.
 Phone: 919-684-6965
 Email: michael.datto@duke.edu
Lab Director:
 Catherine Rehder Ph.D, FACMG
 Phone: 919-613-8434
 Email: catherine.rehder@duke.edu
Lab Director:
 Siby Sebastian Ph.D., DABMG
 Phone: 919-613-8432
 Email: siby.s@duke.edu

Address: 
 Wadsworth Bldg, Cytogenetics, Rm 0220
 2351 Erwin Rd
 Durham,  NC  27705
 Phone: 919-684-2698
 FAX: 919-668-5424

Performing Times:
  Friday only-specimens accepted Monday-Friday