Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Human Papillomavirus (HPV) (Aptima®) Detection With Reflex to HPV Genotypes 16 and 18,45 on High-risk Positive Specimens
Use
Diagnose primary or metastatic neoplasm. 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. If the initial high-risk HPV test is positive, then the residual specimen will be tested for HPV types 16 and 18,45; type 18 cannot be differentiated from type 45.
Special Instructions
Not provided.
Limitations
The accuracy may be compromised if there is an inadequate ectocervical, endocervical, or vaginal cell sample. Excessive lubricant on a vaginal speculum can lead to unsatisfactory Pap results. Insufficient specimen may restrict reprocessing or further HPV testing. A negative result does not eliminate the risk of HPV infection due to potential sampling errors or low viral levels. The assay only identifies 14 common high-risk HPV types. Reflex testing for HPV types 16 and 18,45 occurs under specific conditions.
Methodology
PCR-based (Nucleic Acid Amplification)
Biomarkers
LOINC Codes
- 47528-5
- 19764-0
- 19773-1
- 19763-2
- 52797-8
- 22636-5
- 47527-7
- 59420-0
- 11502-2
- 77399-4
- 77400-0
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
Broom-like technique: Insert the brush into the cervical os and rotate five times. Rinse in PreservCyt® by pushing the brush into the vial's bottom 10 times and twirling it. Discard device. Tighten cap till torque line aligns. Alternatively, insert the brush into the endocervical canal, rotate a quarter to half-turn, swirl in solution 10 times, and discard. Use spatula for ectocervix sampling, vigorously swirl in the vial, and tighten cap.
Patient Preparation
Avoid douches 48 to 72 hours before examination. Do not collect specimen during or immediately after menstruation.
Storage Instructions
Store at room temperature. Pap processing should occur within 21 days of collection. ThinPrep® vial specimens must be processed for HPV testing within 21 days.
Causes for Rejection
Poor collection or labeling, specimen leaks, low quantity, identity discrepancies, submitted in inappropriate vials (e.g., SurePath™), expired vials, or male patient specimens are rejection causes. Pap specimens must not exceed 21 days, and HPV specimens must also comply with this timeframe in ThinPrep® vials.