Thrombin Generation (CAT), Single Subject Report

Test Code

901667

CPT Codes
85397<br>This test is not available for New York patient testing<br>Restricted Client Code

Preferred Specimen

1 mL plasma collected in a 3.2% sodium citrate (light blue-top) tube

Minimum Volume

0.7 mL

Instructions

Collect samples using a 20 gauge needle, do not use a butterfly needle. Samples should be separated within 30 minutes of blood collection as follows: The blood collection tube should be centrifuged at >2000 g for 10 minutes between 18 and 25° C. The plasma should be aspirated by a plastic pipette no less than 1 cm from the buffy coat and transferred
to a plastic tube. The collected plasma should be centrifuged at 10,000 g for another 10 minutes at room temperature (alternatively centrifugation at 2500 g for 20 minutes). Taking care to not disturb the sediment, aspirate the plasma and transfer it into the final transfer vial. Freeze immediately at -70 to -80° C.

Transport Container

Transport tube

Transport Temperature

Frozen

Specimen Stability

Room temperature: Unacceptable
Refrigerated: Unacceptable
Frozen: 30 days

Methodology
Fluorescence 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 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

Set up: Mon-Fri; Report available: 42 days

Reference Range

See Laboratory Report

Clinical Significance

This method is intended to measure the TF-initiated thrombin generation in human plasma, in the presence of a direct fXa inhibitor (apixaban or rivaroxaban), as a pharmacodynamic (PD) marker to demonstrate the ability of andexanet to reverse the anticoagulant activity of the fXa inhibitors.

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.