Gynecologic Pap Test–Age-based Guideline for Cervical Cancer Screening (Cobas® method) Plus Chlamydia/Gonococcus
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 pertinent patient information such as date of birth, previous malignancy, and any therapy history on the cytology test request form. Adherence to these instructions allows for accurate test processing and results interpretation.
Limitations
The accuracy of the test depends on adequate ectocervical and endocervical cell samples. Excessive lubricant use during collection can interfere, resulting in unsatisfactory results. Sampling errors and low infection levels might yield false negatives for HPV. The assay targets 14 high-risk HPV types, and detecting Chlamydia and Gonococcus require specific preparations, restricting test add-ons post specimen collection.
Methodology
Immunoassay (Multiplex Protein Panel)
Biomarkers
LOINC Codes
- 193095
- 22638-1
- 22639-9
- 19767-3
- 19769-9
- 77399-4
- 77400-0
- 50387-0
- 50388-8
Result Turnaround Time
3-6 days
Related Documents
For more information, please review the documents below
Specimen
Cervical Swab
Volume
ThinPrep® vial
Minimum Volume
Not provided
Container
ThinPrep® vial
Collection Instructions
Brush/spatula technique: Insert the brush into the endocervical canal, rotate slightly and transfer to PreservCyt® solution. Discard brush. Swirl ectocervical sample into vial using a spatula. Secure the vial cap past the torque line.
Patient Preparation
Avoid douches 48 to 72 hours before examination. Do not collect during or shortly after menstruation.
Storage Instructions
Store at room temperature for cytology within 21 days; six months for Cobas® HPV testing, never freezing. Test for Chlamydia/Gonococcus must occur within 7 days.
Causes for Rejection
Improper collection, inadequate sample, labeling errors, leakage, insufficient quantity, specimen from male patients, and samples beyond specified age periods.