Human Papillomavirus (HPV) Vaginal Detection with Genotyping for High-Risk Types by PCR
Use
This test is used for detecting high-risk HPV genotypes associated with the development of cervical cancer. It aids in triaging women with abnormal Pap smear results and provides individual genotyping of HPV-16 and/or HPV-18 if present. It helps in clinical monitoring and management but is not intended for medical-legal applications nor in determining treatment needs in the absence of high-grade cervical dysplasia.
Special Instructions
Not provided.
Limitations
This test is not intended for primary cervical cancer screening in women with prior ablative or excisional therapy, who are pregnant, or who have other risk factors like being HIV-positive. The cobas HPV test detects DNA from 14 high-risk genotypes but does not detect HPV low-risk types. Results may vary based on population prevalence and specimen quality.
New York Approved
Methodology
PCR-based (qPCR)
Biomarkers
LOINC Codes
- 77378-8 - HPV16+18+H Risk 12 DNA Pnl Spec
- 61372-9 - HPV16 DNA Spec Ql NAA+probe
- 61373-7 - HPV18 DNA Spec Ql NAA+probe
- 77375-4 - HPV HR 12 DNA Spec Ql NAA+probe
Result Turnaround Time
3-6 days
Related Documents
For more information, please review the documents below
Specimen
Vaginal Swab
Volume
3 mL
Minimum Volume
1 mL
Container
ThinPrep/PreservCyt solution vial
Collection Instructions
Obtain an adequate sampling from the vagina using a sterile polyester-tipped swab. Rinse the swab into the PreservCyt Solution vial immediately and discard the swab.
Patient Preparation
For 24 hours prior, do not use carbomer-containing feminine hygiene products. See cautions for product list.
Storage Instructions
Store at ambient or refrigerated temperature for up to 42 days.
Causes for Rejection
Specimen containing CytoRich Red preservative fluid.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 42 days |
| Refrigerated | 42 days |