Gynecologic Pap Test (Image-guided), Liquid-based Preparation and High-risk HPV (Cobas®) With Reflex to HPV Genotypes 16 and 18 using SurePath™ specimen
Use
Diagnose primary or metastatic neoplasm. Diagnosis of sexually-transmitted HPV infection. The initial high-risk HPV test is used for types 16,18,31,33,35,39,45,51,52,56,58, 59,66, and 68. If the Pap evaluation is within normal limits and the initial HPV test is positive, the specimen will be tested for high-risk HPV types 16 and 18.
Special Instructions
Not provided.
Limitations
Adequate ectocervical, endocervical, or vaginal cell population is necessary for evaluation. Excessive use of lubricating jelly on the vaginal speculum can interfere with cytological examination, leading to unsatisfactory Pap results. Detection of high-risk HPV depends on the number of copies present in the specimen, which may be affected by collection methods, patient factors, and the presence of interfering substances.
Methodology
PCR-based (NAA)
Biomarkers
HPV 16
MicroorganismHPV 18
Microorganism
LOINC Codes
- 47528-5
- 19764-0
- 19773-1
- 19763-2
- 52797-8
- 22636-5
- 22638-1
- 22639-9
- 19767-3
- 19769-9
- 11546-9
- 8251-1
- 59420-0
Result Turnaround Time
3-6 days
Related Documents
For more information, please review the documents below
Specimen
Other
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
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.