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Chromosomal Microarray, Prenatal, ClariSure® Oligo-SNP
Test Code90927
CPT Codes
81229
Preferred Specimen
20 mL amniotic fluid collected in a sterile screw-cap container
Minimum Volume
5 mL (x2) amniotic fluid • 5 mg chorionic villi
Other Acceptable Specimens
10 mg chorionic villi in sterile container with Hanks', Ringer's solution or transport medium • Cultured cells collected in each of two T25 flasks at 70-100% confluency
Instructions
Clinical history/reason for referral is required with test order
Please contact the laboratory Genetic Counselor at 1-866-GENEINFO (1-866-436-3463) prior to submission of samples.
Ship at room temperature. Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.
Please contact the laboratory Genetic Counselor at 1-866-GENEINFO (1-866-436-3463) prior to submission of samples.
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
Refrigerated: Acceptable
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Received frozen
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: 10 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. 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.