SNP Microarray−Prenatal (Reveal®)

This test will detect chromosomal imbalances that could be associated with developmental delay/congenital anomalies. It provides detection of possible uniparental disomy of any chromosome, the percent and location of homozygosity, including the degree of identity by descent.

Chromosome studies are recommended to detect balanced rearrangements that will not be detected by the array. For chromosome analysis, please order Chromosome Analysis, Amniotic Fluid [052040] or Chromosome Analysis, Chorionic Villi Biopsy [510988]. Concurrent maternal contamination (MCC) studies (Maternal Cell Contamination [511402]) are recommended. Pertinent medical findings must accompany the test request form. A complete Informed Consent and Prenatal Chromosome SNP Microarray Questionnaire should accompany specimens. Call 800-345-4363 to request the Informed Consent and Questionnaire form. If a chromosome study or prior cell-free DNA/NIPT studies have been performed, please include copy of the report. If direct amniotic fluid or chorionic villus sample (CVS) submitted, the test number will be changed to SNP Microarray (Direct)−Prenatal (Reveal®) [510200]. If direct submitted under Test No. 510200 does not meet requirements for Microarray testing, the test number will be changed to 510100 and cultures will be needed. If cultures are needed and performed by Labcorp, additional days will be required to complete testing. A delay notification will be sent to the client if cultures are necessary.

This SNP assay does not detect balanced rearrangements, low-level mosaicism (<10%), marker chromosomes that only contain heterochromatin or tetraploidy.

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

SNP microarray analysis is performed using the Cytoscan® HD Accel platform, which uses 743,130 SNP probes and 2,029,441 NPCN probes with a median spacing of 0.818 kb.