Recurrent Miscarriage/Coagulation Panel with Reflex (without Consultation)

Test Code

11469

CPT Codes
81240, 81241, 85300, 85303, 85306, 85613, 85730, 86146 (x3), 86147 (x3), 83516 (x2)

Includes

Lupus Anticoagulant Evaluation with Reflex (PTT-LA and dRVVT with Reflex Confirmations)
Cardiolipin Antibodies (IgA, IgG, IgM)
Beta-2-Glycoprotein I Antibodies (IgG, IgA, IgM)
Protein C Activity
Protein S Antigen, Free
Antithrombin III Activity
Phosphatidylserine/Prothrombin (PS/PT) Antibodies (IgG, IgM)
Prothrombin (Factor II) 20210G→A Mutation Analysis
Factor V (Leiden) Mutation Analysis

If PTT-LA Screen is prolonged (>40 seconds), then Hexagonal Phase Confirmation will be performed at an additional charge (CPT code(s): 85598).
If Hexagonal Phase Confirmation is positive or weakly positive, then Thrombin Clotting Time will be performed at an additional charge (CPT code(s): 85670.

If dRVVT Screen is prolonged (>45 seconds), then dRVVT Confirm will be performed at an additional charge (CPT code(s): 85597).
If dRVVT Confirm is positive, then dRVVT 1:1 Mixing Study will be performed at an additional charge (CPT code(s): 85613).

Preferred Specimen

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

Minimum Volume

3 mL whole blood • 0.5 mL (x4) frozen platelet-poor plasma

Instructions

Whole blood sample is for the Factor V Mutation Analysis and Prothrombin (Factor II) Mutation Analysis.

Platelet-poor plasma is for remaining tests.

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 four plastic vials. Plasma must be free of platelets (<10,000/mcL). Freeze immediately and ship on dry ice.

Transport Temperature

Whole blood: Room temperature
Plasma: Frozen

Specimen Stability

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

Plasma
Room temperature: Unacceptable
Refrigerated: Unacceptable
Frozen: 14 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Hemolysis

Methodology
Chromogenic Clotting Assay • Enzyme Immunoassay (EIA) • Immunoturbidimetric Immunoassay • Polymerase Chain Reaction and Detection

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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

See individual assays

Clinical Significance

This profile examines the most common hereditary and acquired thrombophilia risk factors associated with recurrent miscarriage or stillbirth.

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.