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| 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
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
Fresh tissue: 3 mm3
Other Acceptable Specimens
Formalin-fixed, paraffin-embedded tissue block • 5 mm3 fresh tissue submitted in a leak-proof container
Instructions
Oral Rinse: 5 mL oral rinse using special OralRisk® HPV kit (stock order #160878) (minimum: 1 mL; volume required to perform single analysis, including instrument dead volume).
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.) 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.
Paraffin: Paraffin-embedded fixed tissue collected in a block or 10-20 ribbons 5-10 microns thick.
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 Monday through Friday to arrive by 2:00 pm on Friday on dry ice.
Tissues Frozen at -20°C: Acceptable on a case by case basis. Must be overnighted. Frozen at -70°C: (liquid nitrogen or dry ice per established process).
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.) 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.
Paraffin: Paraffin-embedded fixed tissue collected in a block or 10-20 ribbons 5-10 microns thick.
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 Monday through Friday to arrive by 2:00 pm on Friday on dry ice.
Tissues Frozen at -20°C: Acceptable on a case by case basis. Must be overnighted. Frozen at -70°C: (liquid nitrogen or dry ice per established process).
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
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: 5-7 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.
