Gynecologic Pap Test–Age-based Guideline for Cervical Cancer Screening (Cobas® method) and STDs
Use
Diagnose primary or metastatic neoplasm. Detect Chlamydia trachomatis and Neisseria gonorrhoeae. High-risk HPV is used for types 16 and 18 and a combined result for types 31,33,35,39,45,51,52,56,58,59,66, and 68, without differentiation of the individual type. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy.
Special Instructions
Ensure to include date of birth, Social Security number, previous malignancy, drug and radiation therapy, last menstrual period, postmenopausal status, surgery details, exogenous hormones, abnormal bleeding, abnormal Pap results, IUD, and other pertinent clinical information on the test request form. Pathologist review will be triggered if laboratory personnel suspect reactive/reparative cellular changes, atypical cells, or any cells in premalignant or malignant category. Additional charges may apply in such cases.
Limitations
The test may fail to evaluate properly if there is inadequate cell population from ectocervical, endocervical, or vaginal regions. Lubricating jelly on the vaginal speculum can interfere with the cytologic examination. The specimen volume from liquid-based cytology may limit Pap reprocessing or HPV testing. Negative results do not rule out HPV infection due to potential low levels of infection or sampling errors causing false-negative results. Testing requires special procedures for Chlamydia trachomatis and Neisseria gonorrhoeae, thus can't be added after submission.
Methodology
PCR-based (Nucleic Acid Amplification (NAA))
Biomarkers
LOINC Codes
- 19764-0
- 19773-1
- 19763-2
- 52797-8
- 22636-5
- 22638-1
- 22639-9
- 11546-9
- 50387-0
- 50388-8
Result Turnaround Time
3-6 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
Use brush/spatula technique: Insert brush into endocervical canal, rotate ¼ to ½ turn, place in PreservCyt® solution, swirl vigorously. Obtain ectocervix sample with spatula, swirl, and discard. Store at room temperature.
Patient Preparation
Avoid douches 48 to 72 hours before examination. Do not collect during or shortly after menstrual period.
Storage Instructions
Maintain at room temperature. Pap processing must occur within 21 days of collection. ThinPrep® vial can be stored for 6 months for Cobas® HPV test. Do not freeze.
Causes for Rejection
Improper collection; inadequate specimen; improper labeling; frozen specimen; leakage in transit; insufficient quantity; name discrepancies; male specimens; aged specimens for Pap, HPV, or relevant infections; excessively bloody specimens.