Activated Protein C Resistance with Reflex to Factor V (Leiden) Mutation

Test Code
19704


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


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.


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


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.




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.