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HPV DNA Assay
By Hybrid Capture II

Test code: 395H High Risk only (Recommended).

Method: Hybrid Capture® II.

Specimen requirements: SurePath™: 1.0mL (0.50 mL) minimum. ThinPrep™: 8.0 mL; (4.0 mL) minimum, Ambient temperature.

Cervical Biopsy: Cervical biopsy should be fresh tissue. Use the Digene cytology brush specimen collection kit (available from Genetic Assays). Remove and discard cytology brush and suspend fresh tissue in media within the collection tube. Biopsies should be frozen at –20°C until they are shipped. Cervical biopsies processed with histological fixatives cannot be tested.

Collection and transport: SurePath™: Store and ship at ambient temperature up to 28 days. ThinPrep™: Store and ship at ambient temperature up to 3 months/90 days. Cervical biopsies are frozen and placed in styrofoam cooler with dry ice.

Causes for rejection: SurePath™: Less than 0.5 mL and/or exceeds 28 days. ThinPrep™: Less than 4.0 mL and/or exceeds than 3 months/90 days. Cervical biopsies processed with histological fixatives.

Specimen stability: SurePath™: Stable for up to 28 days at room temperature. ThinPrep™: Stable for up to 3 month at room temperature. Cervical biopsy stable indefinitely at –20°C.

Reference range: Not detected.

TAT: 1-7 Days

CPT code: 87621, papillomavirus human, amplified probe technique (low risk); 87621, papillomavirus human, amplified probe technique (high risk).

Clinical significance: HPV is a family of over 70 viruses of which 18 are associated with anogenital lesions, representing a spectrum of disease ranging from common genital warts to cervical cancer. The HPV DNA test is used for clarification and confirmation of cytologic diagnosis and may be used in triaging patients for possible referral for colposcopy.

The American Society for Colposcopy and Cervical Pathology developed consensus management guidelines that suggest testing for oncogenic/high risk types of HPV DNA to determine the management of “Atypical squamous cells of undetermined significance” when the test can be performed using a liquid-based Pap (already available sample).

This recommendation was based on results form ALTS and other large studies demonstrating that HPV testing was as sensitive as colposcopy in identifying women with an underlying cervical intraepithelial neoplasia (CIN 2 or 3), but reduced the number of referrals by nearly 50 % and data demonstrating the optimal cost-effectiveness of this approach.

The U.S. Food and Drug Administration has approved HPV ancillary testing for management of “Atypical squamous cells of undetermined significance and in March 2003, approval was extended to include primary screening in conjunction with cytology among women 30 years of age and older. Testing should be restricted to oncogenic/high-risk types when possible.

Interpretative data: Women with atypical squamous cells of undetermined significance (ASC-US) should be managed using a program of either repeat cervical cytology testing, immediate colposcopy, or DNA testing for high-risk types of Human Papillomavirus (HPV). Testing for HPV DNA is the preferred approach when liquid-based cytology is used for screening. All women who test positive for high-risk HPV DNA should be referred for colposcopic evaluation. Women with ASC-US who test negative for high-risk HPV DNA can be followed up with repeat cytologic testing at 12 months (2001 ASCCP Guidelines –JAMA 2002; 287:2120-2129)

A positive high risk HPV test result indicates that the patient may be infected with one or more of the following HPV genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68; which are associated with cervical cancer and its precursor lesions. However, cross-reactions with other genotypes may occur. Results should be correlated with cytologic/histologic findings.

Note: A negative result does not rule out the presence of an HPV genotype absent from the test panel, a low level infection, or specimen sampling error.

References:
1. Cox Tanner, James, Lorinez AT, Schiffman Henry, Micheal G., Sherman ME, Cullen A, Kurman RJ: Human Papillomavirus testing by hybrid capture appears to be useful in triaging women with a cytologic diagnosis of atypical squamous cells of undetermined significance. Am.J.Obstet. Gynecol. 1995:172:946-954
2. Wright TC Jr., Cox fJT, Massad LS, Twiggs LB, Wilkinson EJ. 2001 management guidelines for the management of women with cervical cytologic abnormalities. JAMA 2002: 287:287 2120-2129
3. The ALTS Group. Results of a randomized trial on the management of cytology interpretations of atypical squamous cells of undetermined significance. Am J Obstet Gynecol 2003:188:1383-1392.
4. Manos MM, Kinney WK, Hurley LB, et al. Identifying women with cervical neoplasia: using human papillomavirus DNA testing for equivocal Papanicolaou results. JAMA 1999;281: 1605-1610.

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