Nonsyndromic Congenital Heart Disease Panel
Use
The Nonsyndromic Congenital Heart Disease Panel is intended for individuals with relevant features or a clinical or suspected diagnosis of nonsyndromic congenital heart disease. It is also suitable for individuals with isolated structural heart defects without additional systemic features, and for first-degree relatives of individuals with nonsyndromic congenital heart defects who are seeking risk assessment.
Special Instructions
Not provided.
Limitations
The test is not cleared or approved by the US Food and Drug Administration. It follows CAP and CLIA guidelines but may not cover all regions associated with nonsyndromic congenital heart disease. The performance characteristics are validated internally, but the test is subject to the limitations of NGS technology, including the detection of genomic variations present at a frequency below the assay's sensitivity threshold.
New York Approved
Methodology
NGS (Targeted)
Biomarkers
No genes
Gene
Result Turnaround Time
14-21 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
Blood samples should be collected in EDTA tubes and shipped at room temperature.
Storage Instructions
Store samples at room temperature and ship within 48 hours.