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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
Message| Interfaced |
Test Code
ORARISKHPV
Quest Code
90562
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.
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 temparature until ready to ship.
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.
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 temparature until ready to ship.
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 Container
Capped (red-cap) 10 mL skirted tube
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 • Received frozen • Tissue received room temperature or refrigerated • 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
Mon-fri
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 Labs, a service of Access Genetics, LLC
7400 Flying Cloud Drive
Suite 150
Eden Prairie, MN 55344-3720
