Test ID: 89119    
ThinPrep Diagnostic with Human Papillomavirus (HPV) for Women 30 Years and Older

Detection of cervical carcinoma or intraepithelial lesions and the presence or absence of high-risk human papillomavirus (HPV) in women over age 30 at risk for cervical neoplasia

The majority (>99%) of cervical epithelial neoplasms are the result of human papillomavirus (HPV) infection. "High-risk'' HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) can result in both low-grade squamous intraepithelial lesion (LSIL) and high-grade squamous intraepithelial lesion (HSIL), as well as invasive carcinoma.(1,2) Patients with both negative cytology and negative HPV have been shown to be at extremely low risk for cervical neoplasia.(1,2)

For women 30 years and older who have received a negative Pap test and concurrent negative HPV result, the American Cancer Society (ACS) and American College of Obstetricians and Gynecologists (ACOG) recommendations for cervical screening state that physicians may lengthen the screening interval to 3 years when using the combined tests. Patients deemed to be at high risk by the clinician should still be screened more frequently.

The presence of high-risk HPV types in cervical specimens identifies a subgroup of patients with a greater likelihood of having a high-grade squamous intraepithelial lesion. Current guidelines for follow up of a cytology-negative/HPV-positive patient recommend repeat HPV testing in 12 months.(2)

ThinPrep PAP Test Diagnostic:

Satisfactory for evaluation. Negative for intraepithelial lesion or malignancy.

High Risk HPV DNA Detection:

Negative for types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68

Cytology:

Standard reporting, as defined by the Bethesda System (TBS) is utilized.

Human papillomavirus (HPV):

A positive HPV test result indicates the presence of 1 or more of the high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, or 68).

A negative human papillomavirus (HPV) test or Pap smear result does not preclude the presence of carcinoma or intraepithelial lesion; false-negative rates of the Pap test range from 15% to 30%; the false-negative rate of the HPV test (Digene, Hybrid Capture II) is 1.1% to 7.5%.(1,4)

This test is not recommended for patients less than 30 years of age due to the transient nature of the HPV virus in younger patients; 83343 ThinPrep Diagnostic with Human Papillomavirus (HPV) Reflex is available for women under the age of 30 with pap tests diagnosed as ASCUS.

1. Lorincz AT, Richart RM: Human papillomavirus DNA testing as an adjunct to cytology in cervical screening programs. Arch Pathol Lab Med 2003 August;127(8):959-968

2. Wright TC, Jr, Schiffman M: Adding a test for human papillomavirus DNA to cervical-cancer screening. N Engl J Med 2003 February 6;348(6):489-490

3. Soloman D, Davey D, Kurman R, et al: The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA 2002 April;287(16):2114-2119

4. Sherman ME, Lorincz A, Scott DR, et al: Baseline cytology, human papillomavirus testing, and risk for cervical neoplasia: a 10-year cohort analysis. J Nat Cancer Inst 2003 January;95(1):46-52

• Gyn-Cytology Patient Information Sheet