Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia/Gonococcus, NAA With Reflex to Human Papillomavirus (HPV) (Aptima®) When ASC-U
Use
Diagnose primary or metastatic neoplasm; detect Chlamydia trachomatis and Neisseria gonorrhoeae. 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, without differentiation of the individual type.
Special Instructions
Important information such as date of birth, Social Security number, previous malignancy, drug or radiation therapy, last menstrual period, postmenopausal status, any surgical history, use of exogenous hormones, and any history of abnormal vaginal bleeding or Pap results should be included on the cytology test request form. Additional charges may apply for pathologist review if laboratory personnel suspect reactive, atypical, or potentially malignant cellular changes.
Limitations
The test may yield inadequate evaluation if there is a failure to obtain the necessary ectocervical, endocervical, or vaginal cell population. Excessive use of lubricating jelly with the vaginal speculum can interfere with cytologic examination, resulting in unsatisfactory Pap results. Use of the liquid-based cytology specimen for tests other than the Pap or HPV can limit the available volume, potentially impacting reprocessing or additional testing. A negative result does not exclude the possibility of HPV infection due to low levels of infection or sample collection error. The test identifies only the 14 common high-risk HPV types without determining the specific type.
Methodology
PCR-based (Nucleic Acid Amplification (NAA))
Biomarkers
LOINC Codes
- 47527-7
- 50387-0
- 50388-8
Result Turnaround Time
2-6 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (Unknown)
Volume
ThinPrep® vial
Minimum Volume
Not provided
Container
ThinPrep® vial
Collection Instructions
Use the ThinPrep® Vial with Broom or Brush/Spatula technique. For broom-like, sample from the cervix with a brush, rotate five times, rinse in PreservCyt® solution, and discard brush. For spatula, rotate in the endocervical canal then rinse vigorously. Optional Chlamydia and Gonococcus specimen should use a Gen-Probe® Aptima® collection kit and follow specific clean and rotate guidelines.
Patient Preparation
Avoid douches 48 to 72 hours prior to examination. Specimen should not be collected during menstruation or soon after.
Storage Instructions
Maintain at room temperature. Process within 21 days for Pap and 7 days for Chlamydia/Gonococcus.
Causes for Rejection
Improper collection, inadequate specimen, improper labeling, expired vials, specimens submitted on male patients, frozen or leaked specimens in transit.