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(CTC) Alpha-Globin Gene Sequencing
Test Code716116
CPT Codes
99199
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
Minimum Volume
3 mL
Other Acceptable Specimens
ACD solution A (yellow-top), ACD solution B (yellow-top), EDTA (royal blue-top), Sodium fluoride (gray-top), PPT (White-Top) Tube
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 8 DAYS
Refrigerated: 8 DAYS
Frozen: UNACCEPTABLE
Refrigerated: 8 DAYS
Frozen: UNACCEPTABLE
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Wrong test indication • Wrong specimen type • Exceeds
specimen stability • Less than minimum required sample
volume • Blood samples received frozen
specimen stability • Less than minimum required sample
volume • Blood samples received frozen
Methodology
Polymerase Chain Reaction • DNA 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 the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Wed; Reports Tues 3 weeks following setup
Clinical Significance
1. To identify disease-causing mutations in individuals affected with alpha-Thalassemia.
2. To identify carriers in high risk ethnic groups or people with a positive family history.
3. Prenatal diagnosis of alpha-Thalassemia.
2. To identify carriers in high risk ethnic groups or people with a positive family history.
3. Prenatal diagnosis of alpha-Thalassemia.
