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Human Papillomavirus (HPV) Molecular Detection with Genotyping

New test offers high-risk HPV detection (14 high-risk types) with specific genotyping for HPV-16 and HPV-18




February 2014

Cervical Cancer Screening Guidelines
(ACS, ASCCP, ASCP)

The recommended cervical cancer screening guidelines outline what testing should be done and when this testing should be performed and suggest that early detection of HPV-16 and HPV-18 may prevent the progression of cervical cancer.

  • Screening should not start until age 21
    • Sexually active women under the age of 21 are frequently infected with HPV, but most commonly clear the infection over 6 to 12 months
  • Ages 21 through 29: Cytology alone every 3 years
  • Ages 30 through 65: Cytology alone every 3 years OR HPV co-testing (cytology + HPV) every 5 years
    • This extended interval is due to the higher sensitivity of the HPV nucleic acid amplification test (NAAT), and the greater negative predictive value of these assays
  • Co-testing NOT recommended in those younger than age 30
  • Primary HPV testing NOT currently recommended

 

Management of Women with Atypical Squamous Cells of Undetermined Significance (ASC-US)

According to the latest ASCCP recommendations, women with ASC-US (pap smear reveals slightly abnormal squamous cells, but the changes don't clearly suggest that precancerous cells are present) can be managed by either:

  • Repeating cytology testing in 6 to 12 months.
  • Testing the same sample by a HPV NAAT
    • If the result of the HPV test is negative, the patient can be seen again in 3 years for repeat co-testing by cytology and HPV NAAT
    • If the HPV test is positive, the recommendation is to refer the patient to colposcopy


Confirmed Cases of CDG Identified by Mayo Clinic Biochemical Genetics Laboratory

Click to Enlarge

Reprinted from The Journal of Lower Genital Tract Disease Volume L7, Number 5, with the permission of ASCCP @ American Society for Colposcopy and Cervical Pathology 2014. No copies of the algorithms may be made without prior consent of ASCCP.

 

Management of Women ≥ Age 30, Who Are Cytology Negative, but HPV Positive

The recent recommendation from ASCCP on the use of HPV genotyping in women that are positive by a high-risk HPV test, but negative by cytology, state that:

  • If the HPV-16 and HPV-18 genotype results are negative, the patient can be seen again in 12 months for repeat co-testing.
  • If however, the HPV-16 and/or HPV-18 genotype is determined to be positive, the recommendation is to refer those women directly to colposcopy.


This is a significant change in the testing and triage of women that are screened for HPV, and this recommendation is based on data suggesting that early detection of genotypes 16 and/or 18 needs to be investigated sooner rather than later, and by doing so, the progression of cervical cancer may be better prevented.

Confirmed Cases of CDG Identified by Mayo Clinic Biochemical Genetics Laboratory

Click to Enlarge

Reprinted from The Journal of Lower Genital Tract Disease Volume L7, Number 5, with the permission of ASCCP @ American Society for Colposcopy and Cervical Pathology 2014. No copies of the algorithms may be made without prior consent of ASCCP.


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