Pap Test: SurePath™ Liquid-Based with Reflex to Human Papillomavirus (HR-HPV) DNA Probe, High Risk
The BD SurePath™ liquid-based Pap test is an FDA-approved, thin-layer cellpreparation process intended for use in the screening and detection of cervical cancer, precancerous lesions, atypical cells and all other cytologic categories as defined by the Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses.1
1 Kurman RJ, Solomon D (editors). The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses: Definitions, Criteria and Explanatory Notes for Terminology and Specimen Adequacy. New York, Springer Verlag, 1994.
Storage/Transport Temperature: Submit specimens according to Biological Substance, Category B, shipping guidelines.
Remarks: This test includes a cytopathology, SurePath® liquid-based Pap test and an HPV HR-DNA probe. HPV is reflexed only if the SurePath® test is interpreted as atypical squamous cells of undetermined significance in patients ages 21 and over.
- Lack of a properly completed requisition (especially federally required information)
- Insufficient pertinent clinical history
- Obscuring inflammation, debris or excessive air-drying
- Always record if a cytobrush was used to perform the Pap test. Failing to record the use of a cytobrush may result in erroneous atypical results for the patient.
Stability (collection to initiation of testing):\
- SurePath™: 4 weeks at 4° - 37° C
Interpretive report; high-risk HPV negative or positive
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.
Women with atypical squamous cells of undetermined significance (ASC-US) should be managed using a program of either repeat cervical cytopathology testing, immediate colposcopy or DNA testing for high-risk types of human Papillomavirus (HPV). Testing for HR-HPV DNA is the preferred approach when liquid-based cytopathology 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 the cytologic/histologic findings.
The performance characteristics of this test were determined by UF PathLabs, utilizing the FDA-approved Digene HPV-HR Hybrid Capture 2 DNA Test.
- If reflexed to HPV, add 87621, high-risk HPV.