Gynecologic Pap Test (Image-guided), Liquid-based Preparation With Reflex to Human Papillomavirus (HPV) (Aptima®) When ASC-U With Reflex to HPV Genotypes 16 and 18,45
Use
Diagnose primary or metastatic neoplasm. This test aids in the diagnosis of sexually transmitted HPV infection and in the triage of patients with an ASCUS Pap test result. 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 initial high-risk test is positive, then the residual specimen will be tested for HPV types 16 and 18,45; type 18 cannot be differentiated from type 45.
Special Instructions
Not provided.
Limitations
Failure to obtain an adequate cell population from ectocervical, endocervical, or vaginal regions hinders evaluation. Overuse of lubricating jelly on the speculum may cause unsatisfactory results. Liquid-based cytology is limited when used for multiple tests as it can restrict the specimen volume for Pap reprocessing or HPV testing. Negative results do not rule out HPV infection due to potential low-level infection or sampling error. The test identifies only the 14 most common high-risk HPV types, with genotyping of types 16 and 18,45 triggered by initial positive results.
Methodology
Other
Biomarkers
Human Papillomavirus
Microorganism
LOINC Codes
- 47528-5
- 19764-0
- 19773-1
- 19763-2
- 52797-8
- 22636-5
- 22638-1
- 22639-9
- 19767-3
- 19769-9
- 8251-1
- 47527-7
- 11502-2
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
For the Broom technique, use a broom-like device, insert it into the cervical os, rotate five times. Rinse the brush in PreservCyt® solution by pushing and swirling vigorously. For Brush/Spatula technique, insert the brush in the endocervical canal, rotate ¼ to ½ turn, then rinse in PreservCyt®. Use a spatula on ectocervix, rinse vigorously. Ensure the torque line on the cap passes the vial torque line.
Patient Preparation
Avoid douches 48 to 72 hours before examination. Do not collect during or shortly post menstrual period.
Storage Instructions
Maintain at room temperature; must process within 21 days of collection.
Causes for Rejection
Improper collection, labeling, inadequate specimen, leakage, insufficient quantity, male specimen, expired vial, frozen specimen, or vial over 21 days for Pap/HPV testing.