von Willebrand Disease Gene Sequencing

Test Code
36494


CPT Codes
81406

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.


Preferred Specimen
5 mL whole blood collected in EDTA (lavender-top), ACD (yellow-top), sodium heparin (green-top), or sodium heparin (royal blue-top) tube


Minimum Volume
3 mL


Instructions
Whole blood: Normal phlebotomy procedure. Specimen stability is crucial. Store and ship room temperature immediately. Do not freeze.


Transport Temperature
Room temperature


Specimen Stability
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable


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


Methodology
Next Generation Sequencing

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
Set up: as needed, min 1x per week; Report available: 4-6 wks after setup


Clinical Significance
Individuals with a diagnosis, or suspected diagnosis, of von Willebrand disease would be given this test to identify the genetic cause to facilitate appropriate treatment.




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.