HPV, high-risk

Message
Specimen must be submitted using HPV collection kit (supplied by LabCorp), or liquid based cytology preservative. If ThinPrep(R) vials are QNS for the hybrid capture assay, then a test requiring a lower input volume will be automatically performed if ther


Test Code
507301


Alias/See Also
HPV DNA Probe, High-Risk; Hybrid Capture(R)


CPT Codes
87621

Preferred Specimen
Cervical brush sample in Digene DNA collection kit or liquid-based cytology preservative, cervical biopsy


Minimum Volume
For cells collected in liquid-based cytology preservative, at least 4 mL of preservative must be submitted for Cytyc ThinPrep(R) specimens. For TriPath SurePath(R) specimens that have been processed for a Pap, add 2 mL CytoRich(R) fixative to the 0.8 mL


Instructions
Specimen must be submitted using the Digene DNA collection kit (supplied by LabCorp) or liquid-based cytology fixative. Digene DNA collection kit: 1. First remove excess mucus from the cervical os and surrounding ectocervix using a cotton or polyester swab. Discard this swab. 2. To obtain specimen, insert the Digene Cervical Sampling Brush 1.0-1.5 centimeters into the cervical os until the largest bristles touch the ectocervix. Do not insert brush completely into the cervical canal. Rotate brush 3 full turns in a counterclockwise direction, remove from the canal. 3. Insert brush into the transport tube. Snap off shaft at scored line, leaving brush end inside tube, and recap securely by snapping in place. ThinPrep(R) vial-use a cervical broom: 1. Obtain a sample from the cervix using a broom-like device by inserting the brush portion into the cervical os and rotate the brush 5 times. 2. Rinse the collection device in the PreservCyt(R) 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 further release cellular material. Discard the collection device. 3. Tighten the cap on the ThinPrep(R) vial until the cap passes the torque line on the vial. SurePath(R) vial-use a cervical broom: 1. Insert the broom into the cervical os and rotate 5 times. 2. Place the broom head into the CytoRich(R) preservative fluid in the SurePath(R) collection vial. 3. Tightly cap the vial. Tissue: Submit tissue biopsy (frozen) in an HPV collection tube. Biopsies must be shipped frozen at -20(degrees)C.


Transport Container
Digene DNA collection kit (contact the local LabCorp branch for collection kits); or liquid-based cytology preservative (ThinPrep(R) vial with PreservCyt(R) solution or SurePath(R) vial with CytoRich(R) fixative).


Transport Temperature
Maintain liquid-based cytology specimens at room temperature. Maintain Digene HPV collection kit at room temperature for up to 2 weeks, and refrigerated for up to 3 weeks. Freeze biopsy. Cervical specimens collected using the Digene DNA collection kit or


Specimen Stability
Room temp: 3 months; Refrigerate: UNSTABLE; Frozen: Biopsy only


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Improper collection or inadequate specimen; improperly labeled specimen more than 21 days old in Digene DNA collection kit or SurePath(R) liquid-based preservative; specimen more than 3 months old in PreservCyt(R) solution; specimen leaked in transit; qu


Methodology
Nucleic acid amplification (NAA)

Setup Schedule
Tuesday - Saturday 1st and 3rd shift




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.