Chromosomal Microarray, Prenatal, ClariSure^® Oligo-SNP

Test code

90927

CPT code(s)*

81229

**CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.

Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide Service Area Information to find available tests you can order.

In-home collection is not available in your area through Quest Mobile.

Clinical significance

Chromosomal Microarray, Prenatal, ClariSure^® Oligo-SNP - 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.

Test resources

Details

Test details

Methodology

Oligo-SNP Array

Assay category

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.

Alternative name(s)

Microarray, ClariSure^®, Prenatal,ClariSure^® Genomic Alterations,Microarray, Genomic Alterations,Array CGH (aCGH), ClariSure^®,Genomic Alterations,Comparative Genomic Hybridization,Prenatal Microarray, ClariSure^®

Specimen requirements
Patient preparation	None Specified
Preferred specimen(s)	10 mL amniotic fluid collected in each of two genetic transport packs or 10 mg chorionic villus sampling collected in transport media
Alternative specimen(s)	Cultured cells collected in each of two T-25 flasks at 70-100% confluency
Minimum volume	5 mL (x2) amniotic fluid • 5 mg CVS
Collection instructions	Amniotic fluid: 20 mL amniotic fluid in a sterile container. Amniotic fluid tubes available upon request. CVS: 5-10 mg of villi in sterile container with Hanks', Ringer's solution or transport medium. Do not freeze. CVS tubes and media available upon request. Note: Please contact the laboratory Genetic Counselor at 1-866- GENEINFO (866-436-3463) prior to submission of sample. Required sample volumes may change if additional testing is ordered on a single sample.
Transport container	Genetics transport pack (x2)
Transport temperature	Room temperature
Specimen stability	Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.

Reference range(s)

See Laboratory Report

LOINC® codes

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Service Area Information

Performing lab & setup schedule

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Service Area Information

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

*The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.

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