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
Not provided.
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
HPV 16
MicroorganismHPV 18
Microorganism
LOINC Codes
- 47528-5 - Cytology Cvx/Vag Doc Cyto
- 19764-0 - Stat of Adq Cvx/Vag Cyto-Imp
- 19773-1 - Recom F/U Cvx/Vag Cyto
- 19763-2 - Specimen source Cvx/Vag Cyto
- 22636-5 - Path report.relevant Hx Spec
- 22638-1 - Path report.comments Imp Spec
- 22639-9 - Path report.supplemental reports Spec
- 19767-3 - Cytologist Cvx/Vag Cyto
- 11546-9 - Other Stn Spec
- 8251-1 - Service Cmnt-Imp
- 52797-8 - Dx ICD code
- 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
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.