Clinical utility of genotyping human erythrocyte antigens

Abstract

Traditional serological methods, which have been used for decades to evaluate the human erythrocyte antigen (HEA) composition of recipient and donor specimens, have some serious limitations. Specific reagent antisera are not available for all clinically relevant antigens (eg, V antigen). Reagent antisera are expensive, and serological testing is labor intensive. The results of serological testing are subjective and semiquantitative (eg, microscopic, weak, 1+, 2+, 3+, 4+), and may vary from one technologist to another. Further, in many clinical situations, serological testing may be difficult or impossible. Recent developments in nucleic acid-based testing (molecular diagnostics) have made it possible to genotype HEA in the clinical laboratory. Most allelic variations occur due to single nucleotide polymorphisms (SNPs), which can be detected and from which the phenotypes can be predicted. HEA genotyping offers several technical and clinical advantages compared with serological testing. The Immucor PreciseType HEA Test is the first and currently the only platform for clinical testing approved by the United States Food and Drug Administration (FDA), to our knowledge.