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Test Code HPVR Cytology, Human Papillomavirus (HPV) Detection, High Risk Types

Methodology

Digene Hybrid Capture® 2

Performing Laboratory

Munson Medical Center Laboratories

Specimen Requirements

Submit only 1 of the following specimens:

 

Cervical Digene Swab

Test performed on non-pregnant women only.

1. Use the Digene DNA Collection and Transport Kit for HPV and follow specimen collection instructions provided in the kit.

2. Remove excess mucus from the cervical os and surrounding ectocervix using a cotton or Dacron® swab.

3. Discard swab.

4. Insert the Digene brush 1 to 1.5 cm into the cervical os until the largest outer bristles touch the ectocervix.

5. Rotate the brush for 3 full turns in a counter-clockwise direction. Do not insert brush completely into the cervical canal.

6. Remove brush from the canal. Avoid touching the bristles to the outside of the transport tube or any other object.

7. Insert brush to bottom of the transport tube. Snap off shaft at score line and cap tube securely.

8. Label tube with patient’s name (first and last), specimen source, and date and time of collection.

9. Forward promptly at ambient temperature.
Note: 1. Collect specimen for Pap testing before obtaining Digene® swab for DNA testing.

2. Specimen source is required.

3. Include patient’s history and/or clinical impressions on request form.

 

Cervical (PreservCyt® ThinPrep® vial)

1. Collect specimen using the broom-type device and place in Cytyc PreservCyt® solution. (ThinPrep® vial).

2. Obtain adequate specimen of cervix using the broom by inserting broom bristles in the endocervical canal deep enough to allow the shorter bristles to fully contact the ectocervix. Push gently and rotate the bottom in a clockwise direction 5 times.

3. Rinse the broom into the ThinPrep® PreservCyt® solution vial by pushing the broom into the bottom of the vial 10 times forcing the bristles apart. As final step, swirl broom vigorously to further release material and then discard device.

4. Tighten cap on vial so that the torque line on the cap passes the torque line on the vial.

5. Label vial with patient’s name (first and last), specimen source, and date and time of collection.

6. Forward promptly at ambient temperature.
Note: 1. Specimen source is required.

2. Include patient’s history and/or clinical impressions on request form.

Reference Values

Cervical specimens: Negative for 1 or more of HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68

Vaginal specimens: This test is FDA approved for cervical specimens only. Although vaginal specimens may be submitted and tested, the following addendum is included in the report for these specimens. “Performance characteristics and reference ranges have not been established for this specimen type. Results should be interpreted in conjunction with clinical findings.”

Day(s) Test Set Up

Monday through Friday

Test Classification and CPT Coding

87621