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Factor V(5) Leiden Profile

Test Summary

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 common symptoms. Approximately 10 % of individuals positive for APC-Resistance do not have Factor V Leiden and are due to other Factor V mutations.

Aliases

  • N/A

Specimen Collection

Special Instructions

See Link and Print "Drug List for Special Coagualtion Tests"

Preferred Specimen

1 K2EDTA lavender top tube and 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. Also collect ONE (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. Aliquot at least 1mL of plasma into each aliquot tubes labeled; Refer to the Minimum Volume section above for the number of aliquots required per test. Finally, place all aliquots into -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 and dry ice are needed.

Patient Preparation

N/A

Storage

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

N/A

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 <
  • &minus
  • 20 degrees C
  • Unacceptable for K2EDTA lavender top tube

Limitations

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

Other Acceptable Specimens

N/A

Unacceptable Specimens

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.

Order Code

FVLPRP

EPIC (Premier) Code

LAB1430

Includes

Includes APC Resistance and a Factor V Leiden test

CPT Code

  • 85307
  • 81241

Billing Code

  • 301034
  • 300459

CPT Statement

Methodology

Clot Based and Real-Time PCR

FDA Status

FDA approved

Physician Attestation of Informed Consent

N/A

Testing Laboratory

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

Department

Hematology

Reference Range

See Report

Setup Schedule / Expected Turnaround Time

APC-R = SCOAG Tuesday, Friday. FVL= MD once per week; Report available: 8 - 9 days

Specimen Collection

Special Instructions

See Link and Print "Drug List for Special Coagualtion Tests"

Preferred Specimen

1 K2EDTA lavender top tube and 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. Also collect ONE (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. Aliquot at least 1mL of plasma into each aliquot tubes labeled; Refer to the Minimum Volume section above for the number of aliquots required per test. Finally, place all aliquots into -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 and dry ice are needed.

Patient Preparation

N/A

Storage

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

N/A

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 <
  • &minus
  • 20 degrees C
  • Unacceptable for K2EDTA lavender top tube

Limitations

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

Other Acceptable Specimens

N/A

Unacceptable Specimens

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.

Billing

CPT Code

  • 85307
  • 81241

Billing Code

  • 301034
  • 300459

CPT Statement

Result Information

Methodology

Clot Based and Real-Time PCR

Testing Laboratory

N/A

Reference Range

See Report

Setup Schedule / Expected Turnaround Time

APC-R = SCOAG Tuesday, Friday. FVL= MD once per week; Report available: 8 - 9 days