HPV DNA (16, 18, Other High Risk), PCR, Cervical
Use
This test is used for the detection of high‑risk Human Papillomavirus in clinician‑collected cervical samples and can be used as part of an HPV primary screening algorithm. The test detects high‑risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68, which are reported out as HPV 16, HPV 18, and other high‑risk HPV types which includes, but does not differentiate, the remaining 12 high‑risk types. Interim guidance supports the use of an HPV primary screening algorithm, where high‑risk HPV testing is used as a first line screen, in women ≥ 25 years of age. In patients for whom cervical sampling is performed and processed (clinician‑collected), this test supports early identification and risk stratification in accordance with professional guidelines.
Special Instructions
Not provided.
Limitations
Not provided.
Methodology
PCR-based (PCR)
Biomarkers
LOINC Codes
- 59263‑4
- 59264‑2
Result Turnaround Time
2-3 days
Related Documents
For more information, please review the documents below
Specimen
Tumor Tissue
Volume
3 mL (1.5 mL minimum) in PreservCyt® solution in ThinPrep® vial
Minimum Volume
1.5 mL
Container
ThinPrep® vial
Causes for Rejection
SurePath™ pellet; samples treated with acetic acid; vaginal sources; samples from patients who have undergone a hysterectomy
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 90 days |
| Frozen | Unacceptable |