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Activated Protein C Resistance with Reflex to Factor V (Leiden) Mutation
Test Code19704
CPT Codes
85307
Includes
If Activated Protein C-Resistance is <2.1 ratio, then Factor V (Leiden) Mutation Analysis will be performed at an additional charge (CPT code(s): 81241).
Preferred Specimen
2 mL platelet-poor plasma collected in a 3.2% sodium citrate (light blue-top) tube, and
4 mL whole blood collected in an EDTA (lavender-top) tube
4 mL whole blood collected in an EDTA (lavender-top) tube
Minimum Volume
1 mL plasma • 2 mL whole blood
Other Acceptable Specimens
Whole blood collected in an: EDTA (royal blue-top) tube, or ACD-B (yellow-top) tube
Instructions
Note: Plasma and whole blood is required.
Platelet-poor plasma: Centrifuge light blue-top tube 15 minutes at approximately 1500 x g within 60 minutes of collection. Using a plastic pipette, remove plasma, taking care to avoid the WBC/platelet buffy layer and place into a plastic vial. Centrifuge a second time and transfer platelet-poor plasma into a new plastic vial. Plasma must be free of platelets (<10,000/mcL). Freeze immediately and ship on dry ice.
Whole Blood: Preferred shipping temperature is frozen, but room temperature shipping is acceptable.
Platelet-poor plasma: Centrifuge light blue-top tube 15 minutes at approximately 1500 x g within 60 minutes of collection. Using a plastic pipette, remove plasma, taking care to avoid the WBC/platelet buffy layer and place into a plastic vial. Centrifuge a second time and transfer platelet-poor plasma into a new plastic vial. Plasma must be free of platelets (<10,000/mcL). Freeze immediately and ship on dry ice.
Whole Blood: Preferred shipping temperature is frozen, but room temperature shipping is acceptable.
Transport Temperature
Frozen
Specimen Stability
Plasma
Room temperature: Unacceptable
Refrigerated: Unacceptable
Frozen: 60 days
Whole blood
Room temperature: 8 days
Refrigerated: 8 days
Frozen: 30 days
Room temperature: Unacceptable
Refrigerated: Unacceptable
Frozen: 60 days
Whole blood
Room temperature: 8 days
Refrigerated: 8 days
Frozen: 30 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis
Methodology
Polymerase Chain Reaction & Detection • RVTT-Based Assay (Clot-Based)
FDA Status
See individual assays for FDA status
Setup Schedule
Set up and Report available: See individual assays
Reference Range
≥2.1 ratio
Clinical Significance
Activated Protein C Resistance is the most frequent hereditary defect associated with deep vein thrombosis. Over 95% of the APC resistance phenotype is due to the Factor V Leiden Mutation. The APC-resistance assay is a plasma based functional test for the determination of APC resistance caused by the Factor V Leiden Mutation.