Chromosomal Microarray, POC, ClariSure® Oligo-SNP

Test Code

90929

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 x 5 mm tissue collected in a sterile container in Hanks', Ringer's solution or culture medium with antibiotics

Minimum Volume

2 x3 mm tissue • 1 flask cultured cells

Other Acceptable Specimens

Cultured cells collected in each of two T25 flasks at 70-100% confluency

Instructions

Clinical history/reason for referral is required with test order.

Ship at room temperature. 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

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

Setup Schedule

Set up: Daily; Report available: 12 days

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. Approximately 50% of first trimester pregnancy losses are due to chromosome abnormalities. While chromosome analysis on products of conception has an increased failure rate, chromosomal microarray is a DNA-based analysis, which rarely has assay failures.

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.