Chromosomal Microarray, Postnatal, ClariSure® Oligo-SNP

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Test Code

CPT Codes

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

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)

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.

Transport Temperature
Room temperature

Specimen Stability
Room temperature: Preferred
Refrigerated: Acceptable
Frozen: Unacceptable

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. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Daily; Report available: 10 days (Newborn reports are typically available sooner)

Reference Range
See Laboratory Report

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.

Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153

Last Updated: November 29, 2021

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.