Human Papillomavirus (HPV) DNA Detection with Genotyping, High Risk Types by PCR with Papanicolaou Smear Reflex, ThinPrep, Varies
Use
This test is used for screening high-risk human papillomavirus (HPV) infections associated with the development of cervical cancer, with specific genotyping for HPV-16 and/or HPV-18 if present. These types are known for their high risk of progression to cervical cancer, with HPV-16 being the most carcinogenic. The test aids in clinical monitoring and management of patients by identifying the presence of high-risk HPV types. However, it is not intended for medical-legal use, nor for women who have undergone a hysterectomy, or for determining treatment needs in the absence of high-grade cervical dysplasia.
Special Instructions
The test requires a ThinPrep/PreservCyt collection vial, and only one aliquot may be removed before performing the Pap test. Specimen labeling with at least two identifiers is necessary. The test is not recommended for use on women under 25 years old or for vaginal samples, and proper patient preparation includes abstaining from douching, lubricants, or intercourse 24 hours prior to collection.
Limitations
The test does not detect low-risk HPV types and cannot determine cytologic high-grade lesions or predict CIN2-3 development. Negative results do not exclude future high-grade lesions or cancers. Prevalence of HPV may affect test performance, and interference from PCR inhibitors or inadequate sample may cause false negatives. Specimens showing high blood content may produce invalid results. It is not validated for specimens exceeding recommended acetic acid concentrations or for patients with prior therapies, hysterectomy, or other risk factors like pregnancy or immunocompromised status.
FDA ApprovedNew York Approved
Methodology
PCR-based (Real-Time PCR)
Biomarkers
LOINC Codes
- 71432-9
- 31208-2
- 77399-4
- 77400-0
- 71431-1
- 77379-6
Result Turnaround Time
3-14 days
Related Documents
For more information, please review the documents below
Specimen
Other
Volume
20 mL
Minimum Volume
17 mL
Container
ThinPrep/PreservCyt vial
Collection Instructions
Collect using a broom or brush/spatula device and transfer to PreservCyt solution. Ensure proper labeling with two unique identifiers and individual bagging for transport.
Patient Preparation
Avoid douching, lubricants, and intercourse 24 hours before collection.
Causes for Rejection
Specimen containing SurePath preservative; patient under 25 years of age; improper source other than cervix
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 42 days |
| Refrigerated | 42 days |