Gynecologic Pap Test (Image-guided), Liquid-based Preparation With Reflex to Cobas® High-risk HPV With HPV Genotypes 16 and 18 When ASC-U, ASC-H, LSIL, HSIL, AGUS
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 differentiation.
Special Instructions
Not provided.
Limitations
Failure to collect adequate ectocervical, endocervical, or vaginal cell samples can compromise evaluation. Excessive lubricating jelly use can interfere with cytological examination, leading to unsatisfactory results. Limited specimen volume affects the ability to perform reprocessing or additional HPV testing. Detection sensitivity for high-risk HPV depends on viral load, which may be influenced by sampling methods, patient health factors, infection stage, and inhibitory factors in the specimen.
Methodology
PCR-based
Biomarkers
HPV 16
MicroorganismHPV 18
MicroorganismHPV Other High-risk Types
Microorganism
LOINC Codes
- 47528-5
- 19764-0
- 19763-2
- 52797-8
- 22636-5
- 22638-1
- 22639-9
- 19767-3
- 19769-9
Result Turnaround Time
2-4 days
Related Documents
For more information, please review the documents below
Specimen
Other
Volume
ThinPrep® vial
Minimum Volume
Not provided
Container
ThinPrep® vial
Collection Instructions
Brush/spatula technique: Insert the brush into endocervical canal and rotate 1/4 to 1/2 turn. Swirl vigorously in PreservCyt® solution in ThinPrep® vial, and repeat with spatula from ectocervix. Tighten cap securely.
Patient Preparation
Avoid douches 48 to 72 hours before exam. Do not collect during or soon after menstruation.
Storage Instructions
Maintain at room temperature. Pap processing must occur within 21 days of collection. ThinPrep® vials are viable for up to six months prior to Cobas® HPV testing. Do not freeze ThinPrep® specimens.
Causes for Rejection
Improper collection, inadequate specimen, improper labeling, frozen specimen, leakage in transit, insufficient quantity, discrepancies in name, male patients, or outdated vials. Specific to Pap, the specimen is more than 21 days old; for HPV, more than six months old or contaminated with blood.