Human Papillomavirus (HPV) DNA, High Risk

Message

This is a test for Primary HPV screening of women ≥ 25 years old. This test includes Real time PCR for detection of High Risk HPV-16 , HPV-18 , and HPV Other (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) .

Test Code

HPV68

Alias/See Also

Epic: LAB13993

Includes

PCR for detection of High Risk HPV-16 , HPV-18 , and HPV Other (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68)

Preferred Specimen

Original ThinPrep/PreservCyt collection vial is required for testing.

For optimal interpretation, Pap smears should be collected near the middle of the menstrual cycle. Avoid douching, lubricant use, and sexual intercourse for 24 hours prior to specimen collection.

Cervical specimens should be collected by a clinician using an endocervical brush/spatula or a cervical broom and placed in the ThinPrep® Pap Test™ PreservCyt® Solution. NOTE: Products containing carbomer(s), including vaginal lubricants, creams and gels may interfere with the test and should not be used during or prior to collecting cervical specimens.

Specimen source is required.

Submit only 1 of the following specimens:

Broom Collection Device:
Specimen Type: Cervical (endocervical or ectocervical)
Collection Container: ThinPrep/PreservCyt vial
Specimen Volume: 20 mL of solution in ThinPrep/PreservCyt vial

Endocervical Brush/Spatula Collection Device:
Specimen Type: Ectocervix and endocervix
Collection Container: ThinPrep/PreservCyt vial
Specimen Volume: 20 mL of solution in ThinPrep/PreservCyt vial

Instructions

Broom Collection Device:

Obtain adequate sampling from cervix using a broom-like collection device. If desired, use lukewarm water to warm and lubricate the speculum. Insert the central bristles of the broom into the endocervical canal deep enough to allow the shorter bristles to fully contact the ectocervix. Push gently and rotate the broom in a clockwise direction 5 times.
Rinse the broom as quickly as possible into the PreservCyt solution vial by pushing broom into bottom of vial 10 times, forcing the bristles apart.
As a final step, swirl broom vigorously to further release material. Discard the collection device.
Tighten cap on vial so that the torque line on the cap passes the torque line on the vial.
Specimen vial must be labeled with a minimum of 2 unique identifiers (patient's name and medical record number or date of birth).
Bag ThinPrep specimens individually as they have a tendency to leak during transport.
Place labels on the vial and on the bag.

Endocervical Brush/Spatula Collection Device:

Obtain an adequate sampling from the ectocervix using a plastic spatula. If desired, use lukewarm water to warm and lubricate the speculum. Select contoured end of plastic spatula and rotate it 360 degrees around the entire exocervix while maintaining tight contact with exocervical surface.
Rinse spatula as quickly as possible into the PreservCyt solution vial by swirling spatula vigorously in vial 10 times. Discard the spatula.
Next, obtain an adequate specimen from endocervix using an endocervical brush device. Insert the brush into the cervix until only the bottommost fibers are exposed. Slowly rotate 1/4 or 1/2 turn in one direction. Do not over-rotate.
Rinse the brush as quickly as possible in the PreservCyt solution by rotating the device in the solution 10 times while pushing against the PreservCyt vial wall.
Swirl brush vigorously as final step to further release material. Discard the brush.
Tighten the cap so that the torque line on the cap passes the torque line on the vial.
Specimen vial must be labeled with a minimum of 2 unique identifiers (patient's name and medical record number or date of birth).
Bag ThinPrep specimens individually as they have a tendency to leak during transport.
Place labels on the vial.

Specimen Stability

Room temperature: 3 months
Refrigerated: 3 months
Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Specimens with concentrations of whole blood exceed 1.5% (dark red or brown coloration).

Methodology
This test utilizes Roche real time PCR for the detection of high risk Human Papillomavirus (HPV) DNA. The test specifically identifies genotypes HPV16 and HPV18 while concurrently detecting a pool of 12 other high-risk HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68).

Report Available

4 days

Limitations

Results of this test should only be interpreted in conjunction with information available from clinical evaluation of the patient and patient history. A negative test result indicates HPV DNA concentrations are undetectable or below the pre-set threshold. HPV negative results are not intended to prevent women from proceeding to colposcopy. The performance of this HPV test with ThinPrep Pap Test PreservCyt® Solution has not been adequately established for HPV vaccinated individuals. This test is not recommended for evaluation of suspected sexual abuse.
This test is not intended for women who have undergone hysterectomy. Use of over-the-counter products Replens™, RepHresh™ Vaginal Gel and RepHresh™ Clean Balance™ Kit has been associated with false-negative results. Use of Metronidazole Vaginal Gel has been associated with false-negative results.

Reference Range

Negative for HPV16, 18 , 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

Performing Laboratory
Inova Laboratories
2832 Juniper Street
Fairfax, VA 22031

Last Updated: October 27, 2023
Last Review: N. Wolford, October 27, 2023

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.