Related Terms: HPV HR

Test Method: Invader method (Molecular based testing).

Specimen Type: BD Surepath

Availability: Mon–Fri 08:00–17:00; Pathologist on call at all times for consultation.

Special Instructions: Specify pertinent gynecologic and oncologic history, treatment, signs, symptoms, and risk factors. Label vials with patient name. Call laboratory for detailed information on collection technique.

Sample Collection: Submit collection vial with detached Cervex-brush (broom) head in fixative solution. Vaginal specimens are not recommended. See BD web site for collection technique:

Analytic Time: 3–7 days.

Causes for Rejection: Unlabeled specimen. Insufficient amount of epithelial cells, demographic or clinical information for processing.

Usage: HPV HR testing may be used together with cytologic screening (co-screening in patients over age 30 or has a high risk history), reflex testing after certain cytologic diagnosis (ASCUS diagnosis in patients over age 20, LSIL diagnosis in post-menopausal women), or in some cases with lack of correlation between cytologic and histologic findings. The high-risk HPV test detects 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 can occur. The presence of human papillomavirus in the female genital tract is associated with a number of conditions, including genital condyloma, Bowenoid papulosis, and cervical, vaginal, and vulvar intraepithelial neoplasia, carcinoma, and asymptomatic carriers. The results of this assay should be used in conjunction with cytologic findings, biopsy results, physical exam, and medical history, and should not be used as the sole basis for clinical assessment and treatment of patients.

Limitations: The HPV High Risk screen is a screening procedure only and does not indicate which HPV genotype is present.