Thrombophilia Screen II, Inherited

Test Code

11327

CPT Codes
85300, 85303, 85306, 81240, 81241

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

Factor V (Leiden) Mutation Analysis with Reflex to HR2 Mutation Analysis
Prothrombin (Factor II) 20210G→A Mutation Analysis
Antithrombin III Activity
Protein C Activity
Protein C Activity
Protein S Antigen, Free

If Factor V Leiden is Heterozygous for the R506Q mutation, then HR2 testing will be performed at an additional charge (CPT code: 81400).

Preferred Specimen

1 mL frozen platelet-poor plasma collected in each of three separate 3.2% sodium citrate (light blue-top) tubes and
5 mL whole blood collected in a separate EDTA (lavender-top) tube

Minimum Volume

0.5 mL (x3) plasma • 5 mL whole blood

Other Acceptable Specimens

Whole blood collected in: EDTA (royal blue-top) or ACD-B (yellow-top) tube

Instructions

Please submit a separate, frozen vial for each special coagulation assay ordered. Draw blood in a light blue-top tube containing 3.2% sodium citrate, mix gently by inverting 3-4 times. Centrifuge 15 minutes at 1500 g within one hour 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(s). Freeze immediately and transport 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 -20° C: 14 days
Frozen -70° C: 1 year

Whole blood
Room temperature: 8 days
Refrigerated: 8 days
Frozen: 30 days

Methodology
Polymerase Chain Reaction & Detection • Chromogenic Substrate • Clotting Assay • Immunoturbidimetric
Reflex: Fluorescent Microspheres • Oligonucleotide Ligation Assay • Polymerase Chain Reaction (PCR)

FDA Status
**This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

A.M. Sets up 7 days a week.

Report Available

Reports in 2 days.

Clinical Significance

Factor V Leiden (R506Q) is the most common genetic determinant for hereditary venous thrombosis. Another DNA variant, the HR2 allele, has been associated with a 3-4 fold increased risk to venous thrombosis when it occurs in the presence of 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.