Chromosomal Microarray, Postnatal, ClariSure® Oligo-SNP

Test Code

93034

CPT Codes
81229<br><strong>**Restricted use** This code is available to client 4745 and 56275 only</strong>

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

Other Acceptable Specimens

Sodium heparin (royal blue-top), Sodium heparin lead-free (tan-top), EDTA (lavender-top) tube

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.

Transport Temperature

Room temperature

Specimen Stability

Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not reject.

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

Set up: Daily; Report available: 10 days/ Newborn reports available sooner

Clinical Significance

This is a technical only assay, no interpretation will be provided. High resolution detection of chromosome segments involved in copy number variations (loss or gain) and copy neutral regions of homozygosity. Assist in the diagnosis of patients with intellectual disability, developmental delay, multiple congenital anomalies, dysmorphic features or pervasive developmental disorders. Confirm, exclude, (or clarify) the diagnosis of known chromosomal syndromes. Assist in clinical management and genetic counseling.

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.