HPV DNA (16,18, Other High Risk), PCR with Reflex to ThinPrep® Imaging Pap
Also known as: HPV DNA Primary, HPV Primary, DNA
Use
This test is used for the detection of high‑risk Human Papillomavirus (HPV) types 16, 18, and other pooled high‑risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) in clinician‑collected cervical specimens. When positive, it reflexes to ThinPrep® Imaging Pap testing for cytologic evaluation, aiding in cervical cancer screening algorithms in women aged ≥25, consistent with ASCCP guideline‑based cervical cancer screening strategies.
Special Instructions
Reflex ThinPrep Pap is performed if HPV is positive and triggers additional pathologist review and microscopy as needed; specimen should be collected in PreservCyt® ThinPrep vial.
Limitations
Not intended for self‑collected or non‑cervical specimens; specimens with inadequate cellularity or submission in SurePath™ vials, or treated with acetic acid, or from patients post‑hysterectomy may invalidate results or be rejected.
Methodology
PCR-based (PCR)
Biomarkers
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) PreservCyt solution in ThinPrep® vial
Minimum Volume
1.5 mL
Container
ThinPrep® vial
Collection Instructions
Collect cervical specimen using endocervical brush or spatula into ThinPrep PreservCyt solution; follow manufacturer's instructions.
Storage Instructions
Room temperature
Causes for Rejection
Samples in SurePath™ vial; treated with acetic acid; from patients post‑hysterectomy
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 90 days |
| Refrigerated | 90 days |