Gynecologic Pap Test–Age-based Guideline for Cervical Cancer Screening (Cobas® method)
Use
Diagnose primary or metastatic neoplasm. 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
Include patient's date of birth, Social Security number, any previous malignancy, ongoing drug or radiation therapy, last menstrual period, postmenopausal status, history of surgery or biopsies, use of exogenous hormones, and any pertinent clinical information on the cytology test request form. In accordance with CLIA criteria, Pap smears will require pathologist review if suspect cellular changes.
Limitations
Failure to obtain an adequate cell population from ectocervical, endocervical, or vaginal areas affects evaluation accuracy. Use of lubricating jelly can interfere with cytological exams, leading to unsatisfactory results. Liquid-based specimen use across multiple tests may restrict volume available for Pap reprocessing or HPV testing. A negative result does not completely rule out the possibility of HPV infection due to low infection levels or sampling error causing false negatives. This test targets detection of the 14 most common high-risk HPV types only.
Methodology
PCR-based (qPCR)
Biomarkers
LOINC Codes
- 47528-5
- 19764-0
- 19773-1
- 19763-2
- 22636-5
- 22638-1
- 22639-9
- 19767-3
- 11546-9
- 8251-1
- 52797-8
- 71431-1
- 77399-4
- 77400-0
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
Brush/spatula technique: Insert the brush into the endocervical canal, rotate 1/4 to 1/2 turn, then stir the brush in PreservCyt® solution. Obtain an ectocervical sample with a spatula, stir in the vial, discard used tools, and tighten the cap.
Patient Preparation
Avoid douches 48 to 72 hours before the exam. Do not collect during or shortly after menstrual period.
Storage Instructions
Store at room temperature. Pap processing within 21 days of collection. Can be stored up to six months prior to Cobas® HPV test. Do not freeze.
Causes for Rejection
Improper collection, inadequate specimen, labeling errors, freezing, leakage, or insufficient quantity for analysis. Over-aged samples (more than 21 days or six months) and bloody specimens are also unacceptable.