Beta-Globin Complete™

Test Code
14974


CPT Codes
81364

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 an EDTA (lavender-top) tube or ACD (yellow-top) tube


Minimum Volume
3 mL


Other Acceptable Specimens
Sodium heparin (green-top) tube


Instructions
Whole blood: Normal phlebotomy procedure. Specimen stability is crucial. Store and ship room temperature immediately. Glass tubes should not be shipped frozen.


Transport Container
EDTA (lavender-top) tube or ACD (yellow-top) tube


Transport Temperature
Room temperature


Specimen Stability
Room temperature: 8 days
Refrigerated: 8 days
Frozen: 30 days


Methodology
DNA Sequencing • Polymerase Chain Reaction (PCR)

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
Mon, thurs


Report Available
14 days


Limitations
If these mutations are not found by the testing procedure, it does not mean that the risk of carrying or developing beta thalassemia is not present. It simply means that these specific mutations have not seen found with this assay, although other mutations may be present.


Reference Range
See Laboratory Report


Clinical Significance
1) To identify disease-causing mutations in individuals affected with beta-thalassemia.
2) To identify carriers in high-risk ethnic group or people with positive family history.
3) Prenatal diagnosis of beta-thalassemia.


Performing Laboratory
Quest Diagnostics Nichols Institute-San Juan Capistrano, CA
33608 Ortega Highway
San Juan Capistrano, CA 92675-2042




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.