OraRisk® HPV

Test Code

90562

CPT Codes
87624

Includes

If the OralRisk® HPV result is "Detected", then Genotyping will be performed at an additional charge (CPT code: 87999).

Preferred Specimen

5 mL oral rinse using special OraRisk^® HPV kit

Minimum Volume

Oral Rinse: 1 mL
Fresh tissue: 3 mm³

Other Acceptable Specimens

Formalin-fixed, paraffin-embedded tissue block • 5 mm³ fresh tissue submitted in a leak-proof container

Instructions

1. Open collection supplies and visually inspect contents. Proceed only if saline is clear, colorless, and sealed.
2. SWISH and GARGLE with the saline for 30 seconds and then EXPECTORATE into the funneled collection tube.
3. Pour the preservative into the funneled collection tube.
4. Remove (and discard) the funnel then seal collection tube with red-cap.
5. Print patient name and date of birth on the provided barcode labels. Affix one label lengthwise onto the collection tube. The second label is for office use.
6. Place sealed collection tube into the plastic zip seal specimen bag with absorbent pad.
7. Seal specimen bag and place it INTO the kit box. Close and seal box.
8. Store at room temperature until Quest logistics pick up. Discard FedEx shipping envelope if utilizing Quest logistics.

Frozen tissue: Fresh tissue should be frozen on dry ice within 1 hour of collection. Frozen tissue must remain frozen at all times. Freeze/thaw will affect specimen integrity and may lead to erroneous lab results. Ship specimens Mon-Fri to arrive by 2:00 p.m. on Friday on dry ice.

Transport Temperature

Room temperature

Specimen Stability

Oral Rinse
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable
Paraffin block
Room temperature: Indefinitely
Refrigerated: Indefinitely
Frozen: Unacceptable
Tissue
Room temperature: Unacceptable
Refrigerated: Unacceptable
Frozen: See instructions

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

< 1 mL oral rinse in collection tube • Necrotic tissue

Methodology
Polymerase Chain Reaction (PCR)

FDA Status
The analytical and performance characteristics of this laboratory-developed test (LDT) were determined by OralDNA Labs, A Service of Access Genetics, LLC pursuant to Clinical Laboratory Improvement Amendments (CLIA 88) requirements. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not a requirement prior to use for clinical purposes.

Setup Schedule

Set up: Mon-Fri; Report available: 6-8 days

Reference Range

Not detected

Clinical Significance

Identifies presence of HPV and HPV type (high or low risk) to enable clinicians to determine and initiate appropriate monitoring or referral for patients who have positive results.

Performing Laboratory
OralDNA (UYD)
214 Overlook Circle, Suite 120
Brentwood, TN 37027

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.