Red cell genetic identification does not always reflect the phenotypic expression of the red cell antigen, test results must be interpreted with knowledge of how these known polymorphisms affect blood group antigen expression on the red cell surface. For this reason, all red cell genomic testing results will be reviewed by laboratory staff prior to issuing a report.
Molecular analysis periodically is performed by a microarray-based test. In rare cases where the individual has an antigen silenced by a frameshift mutation or deletion of the gene, which does not include the primer or SNP site, a positive phenotype will be reported.
In cases of RhD zygosity testing, depending upon ethnicity, zygosity determination of the D gene may be inconclusive.
The performance characteristics have been established by Bloodworks Northwest. The U.S. Food and Drug Administration (FDA) has not approved this test. However, FDA approval is not currently required for the use of this test. The results are not intended as the sole means for clinical diagnosis or patient management decisions.