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Chromosomal Microarray, POC, ClariSure® Oligo-SNP
Test Code90929
CPT Codes
81229 <br />
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
5x5 mm tissue collected in a sterile container in Hanks', Ringer's solution or culture medium with antibiotics
Minimum Volume
2 x 3 mm
Other Acceptable Specimens
Cultured cells collected in flasks
Instructions
Fetal tissue sample minimum 2x3 mm sterile container in Hanks', Ringer's solution or culture medium with antibiotics or cultured cells from tissue specimen.
See Genetics Specimen Collection Section for detailed specimen instructions.
See Genetics Specimen Collection Section for detailed specimen instructions.
Transport Temperature
Room temperature
Specimen Stability
Room temperature: Preferred
Refrigerated: Acceptable
Frozen: Unacceptable
Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. ***Do not reject***
Refrigerated: Acceptable
Frozen: Unacceptable
Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. ***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: 12 days
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.