Microarray-Products of Conception (POC) Reveal® FFPE, Data Transfer

CPT: 81229
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Test Details

Synonyms

  • aCGH
  • CGH
  • CMA
  • Microarray
  • Microarray Oncology
  • Reveal® SNP Microarray-Products of Conception (POC)
  • SNP Array
  • WGA

Use

Detects chromosomal imbalance that may be associated with fetal loss or solid tumors and is ideal for detection of complete or partial molar pregnancies.

The microarray will detect DNA copy-number changes at a threshold >1Mb for deletions, >2 Mb for duplications. Also will detect copy-neutral changes associated with uniparental disomy and identity by descent.

Limitations

This assay does not detect balanced rearrangements and low level mosaicism, or tetraploidy.

This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA).

Methodology

Whole genome SNP copy number microarray analysis using Molecular Inversion Probe (MIP) technology optimized for highly degraded FFPE samples.

Specimen Requirements

Specimen

Formalin fixed paraffin embedded (FFPE) tissue; fixed cell pellets

Volume

One paraffin block or ten 10-micron thick section slides

Minimum Volume

Sufficient sample to obtain enough DNA to run microarray

Container

Paraffin block transport pouch

Collection

FFPE specimen should be fixed in 10% neutral-buffered formalin or formaldehyde. Cell pellet should be fixed in 3:1 methanol:acetic acid.

Storage Instructions

Room temperature

Causes for Rejection

Improperly embedded preparation; decalcified bone or bone core

Clinical Information

Special Instructions

Pertinent medical findings should accompany the test request form. Please direct questions to genetic customer service at 800-345-4363.

This assay is not approved for patients of New York State physicians.

References

Nauen D, Haley L, Lin MT, et al. Molecular analysis of pediatric oligodendrogliomas highlights genetic differences with adult counterparts and other pediatric gliomas. Brain Pathol. 2016 Mar;26(2):206-214.26206478
Wang Y, Cheng Q, Meng L, et al. Clinical application of SNP array analysis in first-trimester pregnancy loss: a prospective study. Clin Genet. 2017 Jun;91(6):849-858.27883173

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
512029 Reveal(R) Data Transfer FFPE 511998 Specimen Type 31208-2
512029 Reveal(R) Data Transfer FFPE 511999 # of Genotyping Targets N/A
512029 Reveal(R) Data Transfer FFPE 512000 Array Type N/A
512029 Reveal(R) Data Transfer FFPE 512001 Diagnosis 48000-4
512029 Reveal(R) Data Transfer FFPE 512002 Interpretation 62365-2
512029 Reveal(R) Data Transfer FFPE 512003 Director Review 48672-0
512029 Reveal(R) Data Transfer FFPE 512123 PDF 80563-0

For Providers

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