Chromosomal Microarray, POC, 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. 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.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
5 x 5 tissue collected in a sterile container in Hanks', Ringer's solution or culture medium with antibiotics
Minimum Volume
2 x 3 mm
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.
Patient Preparation
N/A
Storage
N/A
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***
Limitations
N/A
Other Acceptable Specimens
Cultured cells collected in flasks
Unacceptable Specimens
N/A
Order Code
POCCHR
EPIC (Premier) Code
LAB5496
Includes
N/A
CPT Code
- 81229
Billing Code
- 670789
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
33608 Ortega Highway
San Juan Capistrano CA, 92675
33608 Ortega Highway
San Juan Capistrano CA, 92675
Department
Reference Testing
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Daily; Report available: 12 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
5 x 5 tissue collected in a sterile container in Hanks', Ringer's solution or culture medium with antibiotics
Minimum Volume
2 x 3 mm
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.
Patient Preparation
N/A
Storage
N/A
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***
Limitations
N/A
Other Acceptable Specimens
Cultured cells collected in flasks
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: 12 days