HUMAN PAPILLOMA VIRUS (HPV) TYPE 16 AND 18 DNA DETECTIO
Label Name: HPV1618
Lab Discipline: Molecular Diagnostics
Institution:  Duke University Health System 
EAP ID:  LAB263 
Last Review:  3/16/2017 2:53:37 PM
Specimen Type
  Cervix
Container & Volume
  Age Group   Container   Volume  
  0  - 18 Years Preservcyt 2  ML
Patient Preparation
  Be sure to include patient's name, history #, date and time of collection, and collector's initials.

 
Collection Notes
  Adult:
  • 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 2 mL of PreservCyt solution remaining to complete the test.

    ANY SAMPLE SENT WITH LESS THAN 2 mL REMAINING WILL BE LIMITED BY VOLUME (IF TEST RESULT IS NEGATIVE).

 
Storage
  For Cervista™ HPV HR testing, cervical specimens can be stored at room temperature (20-30°C) in PreservCyt® Solution for up to 18 weeks prior to performing the test.

Transport
  Cytyc PreservCyt may be shipped at room temperature. DO NOT FREEZE.
Turn Around Time -  Routine: 7 days   Stat: N/A
Reference Values
HPV1618
HPV 16 or 18/45 Genotype NOT detected
Methodology
  This test uses the FDA-approved in vitro nucleic acid amplification test Aptima HPV 16 18/45 Genotype Assay employing the Panther system (Hologic, Bedford, MA) for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of HPV types 16, 18 and 45. This assay is for samples from women that tested positive for high-risk HPV by the Aptima HPV assay. This assay can differentiate HPV 16 from HPV 18 and/or HPV 45, but does not differentiate between HPV 18 and HPV 45.  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/Aptima%20HPV%2016%2018-45%20Genotype%20Assay%20US%20package%20insert%20AW-12821_001_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
    The American Society of Colposcopy and Cervical Pathology (ASCCP) in conjunction with the American Cancer Society recommends testing for high risk (HR) HPV types 16 and 18 (HPV 16 and HPV 18) in women 30 years and older who have negative cytology and a concomitant positive high risk HPV test. This testing can be used to stratify patients for appropriate clinical follow-up (colposcopy for HPV 16/18 positive cases vs. repeat cytology and HR HPV testing at 12 months). This test is also FDA approved for determining the presence or absence of these specific HR HPV types in patients with ASC-US cytology and a positive HR HPV screening test. However, the ASCP guidelines do not currently recommend HPV genotyping in this patient population. 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 (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). For recommendations regarding HPV 16/18 genotype detection, please see the ASCCP 2009 HPV Genotyping Clinical Update (HPV Genotyping Clinical Update 2009 http://www.asccp.org/pdfs/consensus/clinical_update_200904 08.pdf).
   
Indications
    -The American Society of Colposcopy and Cervical Pathology (ASCCP) in conjunction with the American Cancer Society recommends testing for high risk (HR) HPV types 16 and 18 (HPV 16 and HPV 18) in women 30 years and older who have negative cytology and a concomitant positive high risk HPV test.

-This test is also FDA approved for determining the presence or absence of these specific HR HPV types in patients with ASC-US cytology and a positive HR HPV screening test. However, the ASCP guidelines do not currently recommend HPV genotyping in this patient population.
   
Limitations
    This assay is for samples from women that tested positive for high-risk HPV by the Aptima HPV assay. This assay can differentiate HPV 16 from HPV 18 and/or HPV 45, but does not differentiate between HPV 18 and HPV 45. 
   
Related Tests
    HIGH RISK HUMAN PAPILLOMA VIRUS (HPV) DETECTION
   
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: