Chromosomal Microarray, Postnatal, ClariSure® Oligo-SNP
Test Summary
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.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
5 mL whole blood collected in a sodium heparin (green-top) tube
Minimum Volume
3 mL whole blood
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 (2 mL minimum).
Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.
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 (2 mL minimum).
Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Room temperature
Specimen Stability
- Room temperature: Preferred
- Refrigerated: Acceptable
- Frozen: Unacceptable
Limitations
N/A
Other Acceptable Specimens
Whole blood collected in: Sodium heparin (royal blue-top), or sodium heparin lead-free (tan-top), EDTA (lavender-top) tube • Buccal swab collected in ORAcollect Dx OCD-100/OCD-100A • 2 mL saliva collected in 0GD-500 Oragene Dx collection kit (up to the "fill to" line on device, do not count bubbles)
Unacceptable Specimens
N/A
Order Code
POSTNT
EPIC (Premier) Code
LAB6318
Includes
N/A
CPT Code
- 81229
Billing Code
- 670852
CPT Statement
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 the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
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.
Testing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly VA, 20153
14225 Newbrook Drive
Chantilly VA, 20153
Department
Reference Testing
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Daily; Report available: 10 days (Newborn reports are typically available sooner)
Specimen Collection
Special Instructions
N/A
Preferred Specimen
5 mL whole blood collected in a sodium heparin (green-top) tube
Minimum Volume
3 mL whole blood
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 (2 mL minimum).
Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.
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 (2 mL minimum).
Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Room temperature
Specimen Stability
- Room temperature: Preferred
- Refrigerated: Acceptable
- Frozen: Unacceptable
Limitations
N/A
Other Acceptable Specimens
Whole blood collected in: Sodium heparin (royal blue-top), or sodium heparin lead-free (tan-top), EDTA (lavender-top) tube • Buccal swab collected in ORAcollect Dx OCD-100/OCD-100A • 2 mL saliva collected in 0GD-500 Oragene Dx collection kit (up to the "fill to" line on device, do not count bubbles)
Unacceptable Specimens
N/A
Result Information
Methodology
Oligo-SNP Array
Testing Laboratory
N/A
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Daily; Report available: 10 days (Newborn reports are typically available sooner)