TTR DNA Sequence Testing

Message
WHOLE BLOOD - DO NOT CENTRIFUGE


Test Code
14759


Alias/See Also
LAB00330
Transthyretin DNA Sequencing Test
TTR DNA 
TTR DNA SEQUENCING TEST
TTR AMYLOIDOSIS


CPT Codes
81404

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
8 mL whole blood collected in an EDTA (lavender-top) tube


Minimum Volume
6 mL


Instructions

Please label each specimen tube with two forms of patient identification. These forms of identification must also appear on the test requisition. Higher blood volumes ensure adequate DNA quantity, which varies with WBC, specimen condition, and need for confirmatory testing.


Note: DNA yields and quality are better in fresh specimens. However, when necessary, most genetic tests are successful from DNA purified from whole blood that is several days old.



Transport Container
EDTA (lavender-top) tube


Transport Temperature
Room temperature


Specimen Stability
Room temperature: 10 days
Refrigerated: 10 days
Frozen: Unacceptable


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Received frozen


Methodology
Sanger Sequencing

FDA Status
This test was developed and its analytical performance characteristics have been determined by Athena 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
As needed


Report Available
14-28 days


Reference Range
See Laboratory Report


Clinical Significance
Detects sequence variants in the Transthyretin (TTR) gene.


Performing Laboratory
Athena Diagnostics, Inc.
200 Forest Street, 2nd Floor
Marlborough, MA 01752-3023




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.