Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Human Papillomavirus (HPV) (Aptima®)
Use
Diagnose primary or metastatic neoplasm. 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.
Special Instructions
Include date of birth, Social Security number (or other identification number), previous malignancy, drug therapy, radiation therapy, last menstrual period (LMP), postmenopausal patient (PMP), surgery (including surgical biopsies), exogenous hormones, abnormal vaginal bleeding, abnormal Pap results, IUD, and all other pertinent clinical information on the cytology test request form.
Limitations
Inadequate ectocervical, endocervical, or vaginal cell population is suboptimal for evaluation. Excessive use of lubricating jelly on the vaginal speculum will interfere with cytologic examination, possibly leading to unsatisfactory Pap results. The use of the liquid-based cytology specimen for multiple tests may limit the volume available for Pap reprocessing or HPV testing. A negative result does not exclude the possibility of an HPV infection due to potential very low levels of infection or sampling error resulting in a false-negative result.
Methodology
PCR-based (Nucleic acid amplification (NAA))
Biomarkers
LOINC Codes
- 191121
- 47528-5
- 19764-0
- 19773-1
- 19763-2
- 52797-8
- 22636-5
- 59420-0
- 11546-9
- 8251-1
- 47527-7
Result Turnaround Time
2-6 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
Broom-like collection technique: Obtain a sample from the cervix using a broom-like device by inserting the brush portion into the cervical os and rotate the brush five times. Rinse the collection device in the PreservCyt® solution by pushing the brush into the bottom of the vial 10 times. For the brush/spatula technique, insert the brush into the endocervical canal and rotate ¼ to ½ turn in one direction. Rinse the brush in PreservCyt® solution 10 times. Obtain a sample from the ectocervix using a plastic spatula and swirl in the ThinPrep® vial 10 times.
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
Maintain liquid-based cytology specimen at room temperature. Pap processing must be performed within 21 days of collection.
Causes for Rejection
Improper collection; inadequate specimen; improper labeling; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen submitted on male patient; specimen submitted in vial that expired; frozen specimen; SurePath™ vial; liquid-based cytology specimen more than 21 days old.