Gynecologic Pap Test (Image-guided), Liquid-based Preparation and High-risk HPV (Cobas®) With HPV Genotypes 16 and 18 using SurePath™ specimen
Use
Diagnose primary or metastatic neoplasm. The HPV test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high-risk types 31,33,35,39,45,51,52,56,58,59,66, and 68, without further specific differentiation.
Special Instructions
Not provided.
Limitations
The test may have limitations such as a failure to obtain adequate ectocervical, endocervical, or vaginal cell populations, which is suboptimal for evaluation. Excessive use of lubricating jelly on the vaginal speculum can interfere with the cytologic examination and potentially result in unsatisfactory Pap results. Detection of high-risk HPV is contingent on the number of copies present in the specimen and may be influenced by specimen collection methods, patient factors, the stage of infection, and the presence of interfering substances.
Methodology
PCR-based (Nucleic Acid Amplification)
Biomarkers
Human Papillomavirus
Analyte
LOINC Codes
- 47528-5
- 19764-0
- 19773-1
- 19763-2
- 52797-8
- 22636-5
- 22638-1
- 22639-9
- 19767-3
- 19769-9
- 11546-9
Result Turnaround Time
3-7 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (Fixed (Non-FFPE))
Volume
Entire SurePath™ vial
Minimum Volume
Entire SurePath™ vial
Container
SurePath™ vial
Collection Instructions
Using a cervical broom: Insert the broom into the cervical os and rotate five times. Place the broom head into the CytoRich™ preservative fluid in the SurePath™ collection vial. Tightly cap the vial.
Patient Preparation
Patient should avoid douches 48 to 72 hours prior to examination. Specimen should not be collected during or shortly after menstrual period.
Storage Instructions
Room temperature
Causes for Rejection
Improper collection; inadequate specimen; improper labeling; frozen specimen; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen submitted on male patients. For Pap: liquid-based cytology specimen more than 21 days old. For HPV: specimen more than four weeks old in SurePath™ vial; excessively bloody specimens.