Factor V(5) Leiden Profile

Message
For Specimen Integrity during Extreme Weather see the “Lockbox Usage in Extreme Weather” document at the top of this page.

This test needs a completed Anticoagulant Drug List submitted with the specimen. For a copy of the 2 page form click here

 


Test Code
FVLPRP


Alias/See Also
73773


CPT Codes
85307; 81241

Includes
Includes: APC Resistance(76057), Factor V Leiden(76196)


Preferred Specimen
1 K2EDTA lavender top tube

1 plastic (2.7mL) completely filled 3.2% Sodium Citrate (light blue top) tube


Minimum Volume
1 K2EDTA lavender top tube (minimum 0.5mL whole blood)

2 Frozen Capped aliquots of Sodium Citrate plasma (Polypropylene tubes recommended)


Instructions
Use standard venipuncture and disposal techniques. Patient must be at rest 10 minutes before collection.

Collect the required quantity of Sodium Citrate (light blue top) tubes.

 If unable to process specimens within 24 hours of collection then call CompuNet transportation for a STAT pick-up at (937) 297-8262 option 1.

K2EDTA
 lavender tube: Keep as whole blood (do not spin) and maintain at room temperature.

Sodium Citrate (light blue top) tube(s): Process immediately (stable only 24 hours), following instructions below:

Note: We recommend aliquot tubes to be made of polypropylene plastic as this material is safe to freeze at <-70 degrees C.

1. Centrifuge capped Sodium Citrate (light blue top) tubes at 3000 rpm for 10 minutes, or at speed and time required to consistently produce Platelet Poor Plasma (<5/kmm3).

2. Carefully remove the plasma from all Sodium Citrate (light blue top) tubes; avoid disturbing the WBC/buffy coat, and combine all plasma into a plastic conical centrifuge tube.
Note: If the plasma shows any hemolysis, it must be recollected.

3. Centrifuge the plasma in the plastic conical centrifuge tube for a second time as in step 1.

4. In one smooth motion, carefully and quickly pour the centrifuged plasma into a second plastic conical centrifuge tube. A small amount of plasma along with a red cell button should remain on the bottom of the original conical tube if the pour was executed correctly.
Note: This quick-pour method prevents platelet transfer and contamination.

5. Aliquot at least 1mL of plasma into each aliquot tubes labeled “plasma.” Refer to the Minimum Volume section above for the number of aliquots required per test.

6. Finally, place all aliquots into a <-20°C freezer within 4 hours.
Note: Aliquots must remain frozen until they are picked up by the CompuNet courier. Call CompuNet transportation department if frozen specimen boxes are needed.


Transport Container
K2EDTA lavender top tube(s)

Whole blood Sodium Citrate (light blue top) tube(s)
   OR
Frozen - Capped aliquots of Sodium Citrate plasma (Polypropylene tubes recommended)


Transport Temperature
Room Temperature: K2EDTA lavender top tube
                                  Whole blood


Specimen Stability
Room Temperature: K2EDTA lavender top tube <7 days
                                 Whole blood Sodium Citrate (light blue top) tube(s) < 24 hours
Refrigerated: K2EDTA lavender top tube <7 days
                      Unacceptable for Sodium Citrate (light blue top) tubes whole blood or capped plasma aliquots
Frozen: Capped aliquots of Sodium Citrate plasma (Polypropylene tubes recommended) <30 days at <−20 degrees C
               Unacceptable for K2EDTA lavender top tube


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
K2EDTA lavender top tube: Rejected for gross hemolysis and received frozen.

Sodium Citrate Plasma: Rejected for hemolysis, clotted, improper fill, incorrect specimen type, thawed frozen aliquots, refrigerated plasma or blood, expired test tubes, >24 hours old if not processed into separated frozen plasma vials.


Methodology
Clotting, Real-Time PCR

Setup Schedule
APC-R = SCOAG
Tuesday and Friday
FVL= MD
Once per week


Report Available
8 - 9 days


Limitations
Heparin levels >1.0 IU/mL
Antiphospholipid antibodies
Anti-Coagulant medications


Clinical Significance
Activated Protein C Resistance (APC-Resistance, aPCR, Protein C Resistance) is a functional screening assay that will detect Factor V Leiden genetic defects. It is the most common inherited thrombotic disorder. DVT and PE are not uncommon presentations. Approximately 10 % of individuals positive for APC-Resistance do not have Factor V Leiden and are due to other Factor V mutations.


Performing Laboratory
CompuNet Clinical Laboratories, LLC
2308 Sandridge Drive
Moraine, OH 45439


Last Updated: August 17, 2023


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.