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HPV (Human Papillomavirus) High Risk DNA, Hybrid Capture II

HPV (Human Papillomavirus) High Risk DNA, Hybrid Capture II

Test Highlight

HPV (Human Papillomavirus)

High Risk DNA, Hybrid Capture II

Clinical Use

  • Assist in guiding patient management (as adjunct to cervical cytology screening) in women ≥30 years old

  • Assess need for colposcopy in women ≥21 with ASC-US (atypical squamous cells of uncertain significance) Pap test results

Clinical Background

Human papillomavirus (HPV) infection is a very common infection that is associated with condyloma, Bowenoid papulosis, cervical, vaginal, and vulvar squamous intraepithelial lesions (SIL), and cancer. Although HPV infection does not always progress to cancer, >93% of cervical cancer cases are associated with HPV. Thirty of the more than 100 HPV types infect the genital tract. This test detects 13 key types that are associated with an intermediate to high risk of cancer. High-risk HPV DNA testing is appropriate as an adjunct to cervical cytology screening in women 30 to 65 years of age and is also an option for follow-up in women 21-29 years of age with ASC-US (atypical squamous cells of uncertain significance) cervical cytology results.1 Screening beyond age 65 depends on an individual’s previous results on cervical screening and diagnostic testing.1

Method

This nucleic acid hybridization method utilizes a DNA probe cocktail specific for intermediate/high risk serotypes (types 16,18,31,33,35,39,45,51,52,56,58,59,68). Results are reported as “not detected” or as “detected” for high-risk HPV serotype. The specific serotype(s) cannot be reported.

Concordance with polymerase chain reaction (PCR) results is estimated to be 83%.

Interpretive Information

HPV DNA results must be interpreted in conjunction with other clinical and laboratory data. A “Not Detected” result is consistent with the absence of high-risk HPV DNA serotypes, a level of HPV DNA below the detection limit of the assay, or presence of a serotype other than those listed above. A “Detected” result indicates the presence of one or more of these high-risk HPV serotypes.

Below is a summary of follow-up recommendations for specific combinations of HPV and cervical cytology results1:

Age ≥30:

  • Pap test negative/high-risk HPV negative: Routine screening with Pap and high-risk HPV at 5-year intervals

  • Pap test negative/ high-risk HPV positive: Repeat Pap test and high-risk HPV test at 12 months; or test for HPV genotype 16 and/or 18

Age 21-29:

  • Pap test ASC-US/ high-risk HPV negative: Resume routine screening

  • Pap test ASC-US/ high-risk HPV positive: Colposcopy

References

  1. Saslow D, Solomon D, Lawson HW, et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology Screening Guidelines for the Prevention and Early Detection of Cervical Cancer. Am J Clin Pathol. 2012;137:516-542.

The analytical performance characteristics of this assay, when used to test SurePath® or vaginal specimens, have been determined by Quest Diagnostics.

Content reviewed 12/2012

 
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