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Test Details
Turnaround Time
11 - 21 days
Use
This test is used to rule out the presence of maternal cell contamination within a fetal specimen to aid in the accurate interpretation of prenatal molecular genetic or cytogenetic results.
Special Instructions
Maternal samples sent for maternal cell contamination studies should be submitted under a separate requisition from fetal specimens (CVS or amniotic fluid).
Limitations
False positive or negative results may occur for reasons that include genetic variants, blood transfusions, bone marrow transplantation, or erroneous characterization of family relationships. Molecular-based testing is highly accurate, but as in any laboratory test, rare diagnostic errors may occur. Results are provided for identification of maternal cell contamination in the specimen itself, and not for diagnostic purposes.
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
Analysis of short tandem repeat markers by multiplex fluorescent polymerase chain reaction (PCR) and capillary electrophoresis
References
Bacher J, Schumm JM. Development of Highly Polymorphic Pentanucleotide Tandem Repeat Loci with Low Stutter. Promega Corporation Profiles in DNA. 1998;2(2):3-6.
Ensenberger M, Thompson J, Hill B, et al. Developmental validation of the PowerPlex 16 HS System: an improved 16-locus fluorescent STR multiplex. Forensic Sci Int Genet. 2010 Jul;4(4):257-264.20457027
Nagan N, Faulkner NE, Curtis C, Schrijver I, MCC Guidelines Working Group of the Association for Molecular Pathology Clininical Practice Committee. Laboratory guidelines for detection, interpretation, and reporting of maternal cell contamination in prenatal analyses a report of the association for molecular pathology. J Mol Diagn. 2011 Jan;13(1):7-11.21227389
Specimen Requirements
Information on collection, storage, and volume
Specimen
Whole blood or PurFlock buccal swab kit or Oragene Dx saliva kit
Volume
8.5 mL whole blood or PurFlock buccal swab kit or Oragene Dx 500 saliva collection kit
Minimum Volume
3 mL whole blood or PurFlock buccal swab kit or Oragene Dx saliva kit
Container
Lavender-top (EDTA) tube, pink-top (EDTA) tube, tan-top (EDTA) tube, yellow-top (ACD-A) tube, or PurFlock buccal swab kit or Oragene Dx 500 saliva collection kit
Storage Instructions
Standard phlebotomy. Follow PurFlock buccal swab kit or Oragene Dx 500 saliva kit collection instructions. Do not eat, drink, smoke or chew gum 30 minutes prior to collection.
Causes for Rejection
Frozen or hemolyzed specimen; quantity not sufficient for analysis; improper container