Human Papillomavirus (HPV) High Risk Screen, by Transcription-Mediated Amplification (TMA), ThinPrep
Also known as: HPV SCREEN
Use
This FDA-approved test is used for routine cervical cancer screening in combination with cervical cytology (Pap smear) in individuals 30 years or older with a cervix. It is also used as a follow-up test for abnormal cytology results in individuals 21 years or older. The test detects E6/E7 viral messenger RNA of 14 high-risk HPV types that are associated with cervical cancer and its precursor lesions. The test plays a critical role in identifying individuals at risk for cervical cancer, although it does not discriminate between the 14 high-risk HPV types.
Special Instructions
The test requires a cervical, anal, or vaginal specimen collected with a brush or spatula from a ThinPrep kit and placed in PreservCyt Media. Females should avoid high concentrations of antifungal cream or contraceptive jelly and should not douche prior to collection. Specimen source is required for testing.
Limitations
The test's sensitivity may be affected by specimen collection methods, stage of infection, and the presence of interfering substances. A negative high-risk HPV result does not exclude the presence of other high-risk HPV types. It should not be used for screening or management of atypical squamous cells of undetermined significance (ASCUS) in women under age 21. Results must be interpreted alongside other laboratory and clinical data, and a negative result does not rule out future cytologic abnormalities or cancer.
FDA ApprovedNew York Approved
Methodology
PCR-based (Nucleic Acid Amplification)
Biomarkers
LOINC Codes
- 31208-2
- 49896-4
Result Turnaround Time
1-5 days
Related Documents
For more information, please review the documents below
Specimen
Cervical Swab
Volume
Not provided
Minimum Volume
Not provided
Container
ThinPrep kit and PreservCyt Media
Collection Instructions
Collect cervical, anal, or vaginal specimen with brush or spatula from ThinPrep kit and place in PreservCyt Media.
Patient Preparation
Females should avoid high concentrations of antifungal cream or contraceptive jelly, and should not douche prior to time of collection.
Storage Instructions
Refrigerated
Causes for Rejection
Bloody or dark brown specimens. Specimens in any media other than indicated above.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 1 month |
| Refrigerated | 105 days |
| Frozen | Unacceptable |