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

CPT: 81229
Updated on 9/22/2019
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Synonyms

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

Special Instructions

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

There may be an additional charge for formalin positive tissuesamples requiring embedding and pathology.

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

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

<p>There may be an additional charge for formalin positive tissuesamples requiring embedding and pathology.

Related Documents


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

Extracted DNA from received specimen must yield at least 10 ul at a concentration of 8 ng/ul.

Sufficient sample to obtain enough DNA to run microarray

Extracted DNA from received specimen must yield at least 10 ul at a concentration of 8 ng/ul.


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; no fetal visualized on pathology report; only a small area is identified on fixed sample as fetal, and is less than 50% of sample

Improperly embedded preparation; decalcified bone or bone core

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Improperly embedded preparation; decalcified bone or bone core; no fetal visualized on pathology report; only a small area is identified on fixed sample as fetal, and is less than 50% of sample


Test Details


Use

This test will detect chromosomal imbalance that could be associated with developmental delay/congenital anomalies.It provides detection of uniparental disomy of any chromosome, the percent and location of homozygosity, including the degree of identity by descent.It will also allow the detection of complete or partial molar pregnancies.

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.

This test will detect chromosomal imbalance that could be associated with developmental delay/congenital anomalies.It provides detection of uniparental disomy of any chromosome, the percent and location of homozygosity, including the degree of identity by descent.It will also allow the detection of complete or partial molar pregnancies.


Limitations

This SNP assay does not detect balanced rearrangements, low-level mosaicism (<10%), marker chromosomes that only contain heterochromatin, or tetraploidy. Genotypes in some formalin-fixed tissues are unable to be determined, allowing only genomic dosage to be determined.

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

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).

This SNP assay does not detect balanced rearrangements, low-level mosaicism (<10%), marker chromosomes that only contain heterochromatin, or tetraploidy. Genotypes in some formalin-fixed tissues are unable to be determined, allowing only genomic dosage to be determined.

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


Methodology

SNP Microarray analysis is performed using the Oncoscan ® FFPE platform, which uses more than 220,000 SNP probes with a median spacing of 5.0kb, within the majority of genes.

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

SNP Microarray analysis is performed using the Oncoscan ® FFPE platform, which uses more than 220,000 SNP probes with a median spacing of 5.0kb, within the majority of genes.


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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