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Activated Protein C Resistance with Reflex to Factor V (Leiden) Mutation
Test Code19704
CPT Codes
85307
Physician Attestation of Informed Consent
This germline genetic test requires physician attestation that patient consent has been received if ordering medical facility is located in AK, DE, FL, GA, IA, MA, MN, NV, NJ, NY, OR, SD or VT or test is performed in MA.
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 frozen platelet-poor citrated plasma collected in a 3.2% sodium citrate (light-blue-top) tube and
4 mL frozen whole blood collected in an EDTA (lavender-top) tube
4 mL frozen whole blood collected in an EDTA (lavender-top) tube
Minimum Volume
1 mL platelet-poor plasma • 2 mL whole blood
Other Acceptable Specimens
Whole blood collected in: EDTA (royal blue-top) tube or ACD solution B (yellow-top) tube
Instructions
Platelet-poor plasma: Centrifuge light blue-top tube 15 minutes at approx. 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.
Whole Blood: Preferred shipping temperature is frozen, but room temperature shipping is acceptable.
Transport Temperature
Frozen
Specimen Stability
Plasma
Room temperature: 1 hour
Refrigerated: 4 hours
Frozen: 6 months
Whole blood
Room temperature: 8 days
Refrigerated: 8 days
Frozen: 30 days
Room temperature: 1 hour
Refrigerated: 4 hours
Frozen: 6 months
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)
Setup Schedule
See individual assays.
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.