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Arrhythmia Panel
Test Code11440
CPT Codes
81413, 81414<br>Restricted Client Code
Preferred Specimen
5 mL whole blood collected in an EDTA (lavender-top) tube, or 1 buccal swab collected in a sterile leak-proof container
Minimum Volume
2 mL whole blood
Instructions
**Letter of Medical Necessity needed**
Tests for which buccal swabs are not accepted include GenomeSeqDx, XomeDx®Insights, XomeDxXpress®, and Congenital Sideroblastic Anemia. Multiple permitted tests can be ordered on one swab but the DNA yield is limited and additional specimens may be needed to complete testing.
Blood and buccal swabs are not accepted if the patient has ever received an allogeneic bone marrow transplant/stem cell transplant. Cultured fibroblasts are required. GeneDx can provide a punch biopsy kit and can culture fibroblasts on site, as needed.
Labeling: Label with the patient name plus a second identifier such as date of birth, specimen ID or medical record number. If Cord Blood, state so on both the tube and the paperwork.
Tests for which buccal swabs are not accepted include GenomeSeqDx, XomeDx®Insights, XomeDxXpress®, and Congenital Sideroblastic Anemia. Multiple permitted tests can be ordered on one swab but the DNA yield is limited and additional specimens may be needed to complete testing.
Blood and buccal swabs are not accepted if the patient has ever received an allogeneic bone marrow transplant/stem cell transplant. Cultured fibroblasts are required. GeneDx can provide a punch biopsy kit and can culture fibroblasts on site, as needed.
Labeling: Label with the patient name plus a second identifier such as date of birth, specimen ID or medical record number. If Cord Blood, state so on both the tube and the paperwork.
Transport Temperature
Room temperature
Specimen Stability
Blood
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable
Buccal swab
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Blood: Hemolysis • Frozen • Clotted
Buccal swabs: Samples will be rejected if the tinted stabilizing solution leaks out or if the transport tube is not labeled with patient name and additional ID
Buccal swabs: Samples will be rejected if the tinted stabilizing solution leaks out or if the transport tube is not labeled with patient name and additional ID
Methodology
Next Generation Sequencing
FDA Status
This test was developed, and its performance characteristics determined by GeneDx. This test has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. The laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing.
Setup Schedule
Set up: As needed; Report available: 4 weeks
Reference Range
Negative
Clinical Significance
-Molecular confirmation of a clinical diagnosis in symptomatic individuals
-Risk assessment of asymptomatic family members of a proband with arrhythmia
-Differentiation of hereditary arrhythmia from acquired (non-genetic) arrhythmia
-Recurrence risk calculation
