| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
OraRisk® HPV
Test Code90562
CPT Codes
87624
Preferred Specimen
5 mL oral rinse using special OraRisk® HPV kit
Minimum Volume
1 mL
Other Acceptable Specimens
Formalin-fixed, paraffin-embedded tissue block 5 mm x3 (3 mm x3) frozen tissue
Instructions
1) Open collection supplies and visually inspect contents. Proceed only if saline is clear, colorless and sealed. Set aside box, specimen bag, barcodes, and FedEx Clinical Pak.
(2) SWISH and GARGLE with the saline for 30 seconds and then EXPECTORATE into the funneled collection tube.
(3) Remove (and discard) the funnel then seal collection tube with red cap.
(4) 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.
(5) Place sealed collection tube into the plastic zip seal specimen bag with absorbent pad. (6) Seal specimen bag and place it INTO the box. Close box, store at room temperature until ready to ship.
Alternatively, collected specimens can be stored at 4-8°C (refrigerated).
Tissue, Frozen:
Optimal Volume: 5 mm x 5 mm x 5 mm frozen tissue
Minimum Volume: 3 mm x 3 mm x 3 mm frozen tissue
Frozen at -20 degrees C is acceptable on a case-by-case basis.
Sample MUST be overnighted.
Frozen at -70° C (liquid nitrogen or dry ice) per established process.
Processing and Shipping
Specimen Processing: Fresh tissue should be frozen on dry ice within 1 hour of collection.
Stability: Frozen tissue MUST remain frozen at all times. Freeze/thaw will affect specimen integrity and may lead to erroneous lab results.
Shipping instructions: Ship specimens Mon-Fri to arrive by 2:00 pm on Friday on dry ice.
(2) SWISH and GARGLE with the saline for 30 seconds and then EXPECTORATE into the funneled collection tube.
(3) Remove (and discard) the funnel then seal collection tube with red cap.
(4) 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.
(5) Place sealed collection tube into the plastic zip seal specimen bag with absorbent pad. (6) Seal specimen bag and place it INTO the box. Close box, store at room temperature until ready to ship.
Alternatively, collected specimens can be stored at 4-8°C (refrigerated).
Tissue, Frozen:
Optimal Volume: 5 mm x 5 mm x 5 mm frozen tissue
Minimum Volume: 3 mm x 3 mm x 3 mm frozen tissue
Frozen at -20 degrees C is acceptable on a case-by-case basis.
Sample MUST be overnighted.
Frozen at -70° C (liquid nitrogen or dry ice) per established process.
Processing and Shipping
Specimen Processing: Fresh tissue should be frozen on dry ice within 1 hour of collection.
Stability: Frozen tissue MUST remain frozen at all times. Freeze/thaw will affect specimen integrity and may lead to erroneous lab results.
Shipping instructions: Ship specimens Mon-Fri to arrive by 2:00 pm on Friday on dry ice.
Transport Temperature
Room temperature
Specimen Stability
Oral rinse
Room temperature: 7 days
Rrefrigerated: 7 days
Frozen: Unacceptable
Formalin-fixed, paraffin-embedded tissue
Room temperature: Indefinite
Refrigerated: Indefinite
Frozen: Unacceptable
Tissue
Room temperature: Unacceptable
Refrigerated: Unacceptable
Frozen: Acceptable on a case by case basis. Must be overnighted.
Frozen: -70° C (liquid nitrogen or dry ice) per established process
Room temperature: 7 days
Rrefrigerated: 7 days
Frozen: Unacceptable
Formalin-fixed, paraffin-embedded tissue
Room temperature: Indefinite
Refrigerated: Indefinite
Frozen: Unacceptable
Tissue
Room temperature: Unacceptable
Refrigerated: Unacceptable
Frozen: Acceptable on a case by case basis. Must be overnighted.
Frozen: -70° C (liquid nitrogen or dry ice) per established process
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) was determined by OralDNA Labs pursuant to Clinical Laboratory Improvement Amendments (CLIA 88) requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.
Setup Schedule
Set up: Mon-Fri; Report available: 5 days
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.
