Gynecologic Pap Test (Image-guided), Liquid-based Preparation With Reflex to High-risk HPV (Cobas®) When ASC-U using SurePath™ specimen
Use
Diagnose primary or metastatic neoplasm. The high-risk HPV test is used for types 16,18,31,33,35,39,45,51,52,56,58, 59,66, and 68, without differentiation of the individual type. This assay aids in the diagnosis of sexually-transmitted HPV infection and in the triage of patients with an ASC-U pap smear result.
Special Instructions
Not provided.
Limitations
The test may face limitations such as a failure to obtain an adequate ectocervical, endocervical, or vaginal cell population, which is considered suboptimal for evaluation. The use of excessive lubricating jelly on the vaginal speculum can interfere with cytologic examinations, resulting in unsatisfactory Pap results. Detection of high-risk HPV is dependent on the number of copies present in the specimen, and can be affected by specimen collection methods, patient factors, stage of infection, and the presence of interfering substances.
Methodology
Other
Biomarkers
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
- 52797-8 - Dx ICD code
- 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
- 19769-9 - Pathologist Cvx/Vag Cyto
- 8251-1 - Service Cmnt-Imp
- 47527-7 - Cytology Cvx/Vag Doc Thin Prep
- 59420-0 - HPV I/H Risk 4 DNA Cvx Ql Probe+sig amp
Result Turnaround Time
2-6 days
Related Documents
For more information, please review the documents below
Specimen
Other
Volume
Entire SurePath™ vial
Minimum Volume
Entire SurePath™ vial
Container
SurePath™ vial
Collection Instructions
Using a cervical broom: Insert the broom into the cervical os and rotate five times. Place the broom head into the CytoRich™ preservative fluid in the SurePath™ collection vial. Tightly cap the vial.
Patient Preparation
Patient should avoid douches 48 to 72 hours prior to examination. Specimen should not be collected during or shortly after menstrual period.
Storage Instructions
Room temperature
Causes for Rejection
Improper collection; inadequate specimen; improper labeling; frozen specimen; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen submitted on male patients. For Pap: liquid-based cytology specimen more than 21 days old. For HPV: specimen more than four weeks old in SurePath™ vial; excessively bloody specimens.