Gynecologic Pap Test (Image-guided), Liquid-based Preparation With Reflex to Human Papillomavirus (HPV) (Aptima®) When ASC-U, ASC-H, LSIL, HSIL, AGUS 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 abnormal 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, without differentiation of the individual type. Positive high risk HPV test results reflex the sample for genotyping of types 16 and 18/45.
Special Instructions
Not provided.
Limitations
This test's limitations include potential failure to obtain an adequate sample from ectocervical, endocervical, or vaginal cell populations, which is suboptimal for evaluation. Excessive lubricating jelly on the vaginal speculum can interfere with cytological examination and cause unsatisfactory results. Using the liquid-based cytology specimen for multiple tests may limit the volume available for reprocessing or HPV testing. A negative result does not rule out the possibility of HPV as low-level infections or sampling errors might produce false negatives. It only detects 14 high-risk HPV types and cannot specify which type is present.
Methodology
PCR-based (NAA)
Biomarkers
LOINC Codes
- 47527-7
- 47528-5
- 19764-0
- 19773-1
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-like collection technique, use a broom-like device to sample from the cervix, rinse the device in PreservCyt® solution by inserting and rotating the brush, and finally release additional material by twirling the brush. Discard the device after collection. In the brush/spatula technique, first use the brush in the endocervical canal, then use a spatula for the ectocervix, rinsing each in the PreservCyt® solution before discarding.
Patient Preparation
Avoid douches 48 to 72 hours before the exam. Do not collect during or shortly after the menstrual period.
Storage Instructions
Maintain at room temperature; process within 21 days for Pap testing.
Causes for Rejection
Rejection conditions include improper collection or labeling, inadequate specimen volume, leakage, name discrepancies, expired or incompatible vials, frozen specimens, and samples over 21 days old.