Human Papillomavirus (HPV) (Aptima®)
Use
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.
Special Instructions
Patient preparation should include avoiding douches 48 to 72 hours prior to the examination, and specimens should not be collected during or shortly after a menstrual period to prevent contamination. Ensure that specimen collection follows guidelines using the ThinPrep® Vial with proper collection techniques to ensure sample integrity for accurate testing. The specimen must be kept at room temperature and processed within 21 days of collection to maintain viability for HPV detection.
Limitations
The test does not determine specific HPV types within the detected high-risk group due to its design for broad detection of high-risk types without differentiation. Negative results do not exclude the possibility of an HPV infection as very low levels of infection, or sampling errors might lead to false-negative results. Additionally, the test only covers the 14 most common high-risk HPV types and not the low-risk types, limiting its applicability in certain diagnostic contexts.
Methodology
PCR-based (NAA)
Biomarkers
LOINC Codes
- 59420-0
- 59420-0
Result Turnaround Time
2-4 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 collection technique: Obtain a sample from the cervix using a broom-like device by inserting the brush portion into the cervical os and then rotate the brush five times. Rinse the collection device in the PreservCyt® solution by pushing the brush into the bottom of the vial 10 times, forcing the bristles to bend apart to release the cervical material. As a final step, twirl the brush between the thumb and forefinger vigorously to release additional cellular material. Discard the collection device. Tighten the cap on the ThinPrep® vial so that the torque line on the cap passes the torque line on the vial. Brush/spatula technique: Insert the brush into the endocervical canal until only the bottommost fibers are exposed. Slowly rotate the brush a ¼ to ½ turn in one direction. Then, rotate the brush in the PreservCyt® solution 10 times while pushing against the wall of the ThinPrep® vial. Swirl the brush vigorously to release additional material. Discard the brush.
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
Maintain specimen at room temperature. Specimens in ThinPrep® vials must be processed within 21 days of collection for HPV.
Causes for Rejection
Improper collection; inadequate specimen; improper labeling; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen submitted on male patient; specimen submitted in vial that expired according to manufacturer's label; frozen specimen; SurePath™ vial. For HPV: specimen more than 21 days old in ThinPrep® vial.