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Chromosomal Microarray, Prenatal, ClariSure® Oligo-SNP
Test Code90927
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
10 mL amniotic fluid collected in each of two genetic transport packs or
10 mg chorionic villus sampling collected in transport media
10 mg chorionic villus sampling collected in transport media
Minimum Volume
5 mL (x2) amniotic fluid • 5 mg CVS
Other Acceptable Specimens
Cultured cells collected in each of two T-25 flasks at 70-100% confluency
Instructions
Amniotic fluid: 20 mL amniotic fluid in a sterile container. Do Not Freeze. Amniotic fluid tubes available upon request.
CVS: 10 mg of villi in sterile container with Hanks', Ringer's solution or transport medium. Do not Freeze. CVS tubes and media available upon request.
Please contact the laboratory Genetic Counselor at 1-866-GENEINFO (1-866-436-3463) prior to submission of sample. Required sample volumes may change if additional testing is ordered on a single sample.
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
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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Evening
Clinical Significance
Chromosomal microarray (CMA) detects aneuploidies, deletions and duplications below the resolution of chromosome analysis (karyotyping), and long continuous regions of homozygosity. This assay may be useful for investigation of fetuses with abnormal ultrasound findings, abnormal prenatal screening, definition of unbalanced cytogenetic abnormalities, and follow-up to a documented chromosome or microarray abnormality in a sibling or a parent. Microarray analysis may also be used as follow up for a family history of a previous child with developmental delay, intellectual disability, and/or congenital malformations.
