Gynecologic Pap Test−Age-based Guideline for Cervical Cancer Screening (Cobas® method) Plus Chlamydia/Gonococcus/Trichomonas
Use
Diagnose primary or metastatic neoplasm. Detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. 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
Not provided.
Limitations
Failure to obtain an adequate ectocervical, endocervical, or vaginal cell population can hinder evaluation quality. Using excessive lubricant on the speculum may obscure cytologic evaluation and lead to inadequate results. The liquid-based cytology specimen might not suffice for both Pap reprocessing and additional HPV testing. A negative result does not exclude the likelihood of HPV infection due to potential low infection levels or sampling error, which may cause false negatives. The test detects only 14 common high-risk HPV types and requires specific procedures for processing specimens to test for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis, and cannot include additional testing after submission.
Methodology
Other
Biomarkers
LOINC Codes
- 19764-0 - Stat of Adq Cvx/Vag Cyto-Imp
- 47528-5 - Cytology Cvx/Vag Doc Cyto
- 50387-0 - C trach rRNA Cvx Ql NAA+probe
- 50388-8 - N gonorrhoea rRNA Cvx Ql NAA+probe
- 46154-1 - T vaginalis rRNA Spec Ql NAA+probe
- 71431-1 - HPV HR 12 DNA Cvx Ql NAA+probe
- 77399-4 - HPV16 DNA Cvx Ql NAA+probe
- 77400-0 - HPV18 DNA Cvx Ql NAA+probe
- 47527-7 - Cytology Cvx/Vag Doc Thin Prep
Result Turnaround Time
3-6 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (Fresh)
Volume
ThinPrep® vial
Minimum Volume
Not provided
Container
ThinPrep® vial
Collection Instructions
Use the brush into the endocervical canal, rotate 1/4 to 1/2 turn, then in PreservCyt® solution swirl vigorously, discard the brush. Collect ectocervix sample with plastic spatula, swirl and discard the spatula, tighten vial cap to the torque line.
Patient Preparation
Avoid douches 48 to 72 hours before examination. Do not collect during or soon after menstrual period.
Storage Instructions
Keep at room temperature. Perform Pap processing within 21 days after collection. ThinPrep® vials may be kept for six months before Cobas® HPV test. Don't freeze. Cytology specimens for tests must be used within seven days.
Causes for Rejection
Collection errors, inadequate volume, labeling errors, specimen leak in transit, inadequate quantity for analysis, name discrepancies, specimens from male patients, inappropriate storage timeframes, excessively bloody specimens.