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Chromosomal Microarray, Postnatal, ClariSure® Oligo-SNP
Test Code16478
CPT Codes
81229
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 a sodium heparin (green-top) tube
Minimum Volume
3 mL whole blood • 2 mL saliva
Other Acceptable Specimens
Whole blood collected in: Sodium heparin (royal blue-top) tube, sodium heparin lead-free (tan-top) tube, or EDTA (lavender-top) tube • Buccal Swab collected in ORAcollect-Dx OCD-100/OCD-100A • Saliva collected in 0GD-500 Oragene Dx collection kit up to the "fill to" line on the device
Instructions
Whole blood, Critical NICU/Neonates 0.5 mL. All others 3-5 mL (3 mL minimum).
Green vacutainer (sodium heparin) or Lavender Top (EDTA). Ship at room temperature. Other vacutainer tubes containing sodium heparin are acceptable.
Buccal swab collected in ORAcollect-DX OCD-100/OCD-100A*(*Device contains insert) or Saliva collected in 0GD-500 Oragene Dx collection kit up to the "fill to" line on the device, do not count bubbles (minimum 2 mL).
Green vacutainer (sodium heparin) or Lavender Top (EDTA). Ship at room temperature. Other vacutainer tubes containing sodium heparin are acceptable.
Buccal swab collected in ORAcollect-DX OCD-100/OCD-100A*(*Device contains insert) or Saliva collected in 0GD-500 Oragene Dx collection kit up to the "fill to" line on the device, do not count bubbles (minimum 2 mL).
Transport Temperature
Room temperature
Specimen Stability
Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.
Room temperature: Preferred
Refrigerated: Acceptable
Frozen: Unacceptable
Room temperature: Preferred
Refrigerated: Acceptable
Frozen: Unacceptable
Methodology
Oligo-SNP Array
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
Evening
Clinical Significance
Chromosomal microarray (CMA) detects aneuploidies, deletions and duplications below the resolution of chromosome analysis (karyotyping), and long continuous regions of homozygosity. CMA analysis can help to determine genetic causes of developmental delay (DD), intellectual disability (ID), dysmorphic features, congenital anomalies and pervasive developmental disorders. This test can also be ordered on parents to determine if a copy number variant in a child is inherited or de novo.
