ThinPrep Screen with Human Papillomavirus (HPV) Reflex
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Squamous cell carcinoma of the cervix is believed to develop in progressive stages from normal through precancerous (dysplastic) stages, to carcinoma in situ, and eventually invasive carcinoma. This sequence is felt to develop over a matter of years in most patients.
Follow up of the cervical Pap abnormality "atypical squamous cells of undetermined significance (ASCUS)" is costly and frustrating to patients and clinicians because a large percentage of these patients have normal colposcopic and biopsy findings. Yet, a significant percentage (10% - 15%) will have an underlying high grade squamous intraepithelial lesion (HSIL).
The majority (>99%) of cervical epithelial neoplasms are the result of human papillomavirus (HPV) infection. Some HPV types ("low-risk", types 6 and 11) are associated with low-grade squamous intraepithelial lesions (LSIL) that are benign and do not progress to carcinoma. "High-risk" HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) can result in both LSIL and HSIL, as well as invasive carcinomas. Patients with HSIL have a greater risk for progression to carcinoma.
In the setting of an ASCUS Pap result, the presence of high risk HPV types in cervical specimens, identifies a subgroup of patients with a greater likelihood of having a HSIL.
Triage of equivocal Pap abnormalities (atypical squamous cells of undetermined significance [ASCUS])
Standard reporting, as defined by the Bethesda System (TBS) is utilized.
Human papillomavirus (HPV):
A positive 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).
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
A negative human papillomavirus (HPV) test or Pap smear result does not preclude the presence of carcinoma. The 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%.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Satisfactory for evaluation. Negative for intraepithelial lesion or malignancy.
Note: Abnormal results will be reviewed by a pathologist at an additional charge.
Clinical References Provides recommendations for further in-depth reading of a clinical nature
1. Solomon D, Schiffman M, Tarone R: Comparison of three management strategies for patients with atypical squamous cells of undetermined significance: baseline results from a randomized trial. J Natl Cancer Inst 2001;93:293-299
2. Soloman D, Davey D, Kurman R, et al: The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA 2002;287:2114-2119
3. Wright TC, Cox JT, Massad LS, et al: 2001 consensus guidelines for the management of women with cervical cytological abnormalities. JAMA 2002;287:2120-2129
4. Massad LS, Einstein MH, Huh WK, et al: 2012 updated consensus guidelines for the management of abnormal cervical cancer screening tests and cancer precursors. J Low Genit Tract Dis 2013 April;17(Supplement 1):S1-S27