Gynecologic Pap Test (Image-guided), Liquid-based Preparation and High-risk HPV (Cobas®) With Reflex to HPV Genotypes 16 and 18
Use
Diagnose primary or metastatic neoplasm. Diagnosis of sexually-transmitted HPV infection. The initial high-risk HPV test is used for types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. If the Pap evaluation is within normal limits and the initial HPV test is positive, the specimen will be tested for high-risk HPV types 16 and 18. 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 collect adequate ectocervical, endocervical, or vaginal cells can impact evaluation. Excessive use of lubricating jelly on the speculum interferes with cytologic examination and may lead to unsatisfactory Pap results. The liquid-based cytology specimen's use for multiple tests might limit the volume for Pap processing or HPV testing. Detection of high-risk HPV depends on the number of copies present and may be affected by collection steps, patient status, infection stage, and interfering substances.
Methodology
PCR-based (Nucleic Acid Amplification)
Biomarkers
LOINC Codes
- 47528-5
- 19764-0
- 19773-1
Result Turnaround Time
2-6 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 slowly 1/4 to 1/2 turn, then swirl the brush in the PreservCyt® solution vigorously. Obtain an adequate ectocervix sample using a plastic spatula and swirl in the ThinPrep® vial.
Patient Preparation
Avoid douches 48 to 72 hours before examination. Do not collect during or soon after menstrual period.
Storage Instructions
Store at room temperature. Process Pap tests within 21 days of collection. ThinPrep® vials can be stored up to six months before Cobas® HPV testing. Do not freeze ThinPrep® specimens.
Causes for Rejection
Improper collection, inadequate specimen, improper labeling, frozen specimen, leakage during transit, insufficient quantity for analysis, name discrepancies, or specimen older than six months. For Pap: specimen more than 21 days old.