TTR DNA Sequencing Test

Test Code
14759


CPT Codes
81404<br /> Restricted Client Code

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
Physician Attestation of Informed Consent - This germline genetic test requires physician attestation that patient consent has been received. Non-critical.

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

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

Setup Schedule
Set up: As needed; Report available: 28-42 days


Report Available
28 Days


Reference Range
See Laboratory Report


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




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.