Performance evaluation study of ID RHD XT, a new genotyping assay for the detection of high-prevalence RhD negative and weak D types

Vox Sang. 2018 Oct;113(7):694-700. doi: 10.1111/vox.12701. Epub 2018 Aug 19.

Abstract

Background and objectives: Routine serologic D typing does not distinguish between weak D subtypes and partial D phenotypes. The goal of this study was to validate the performance of the ID RHD XT genotyping assay.

Material and methods: Previously serotyped samples for D antigen (n = 1000; 16% weak D serotyped donors) were analysed. The reference methods used for comparison were licensed serology tests for D antigen phenotype, and bidirectional sequencing (BDS) for weak D type confirmation and HPA-1 phenotype prediction. Discrepancies were solved with BDS and BLOODchip® Reference.

Results: There were no system failure, a 100% call rate and no inconclusive results. ID RHD XT correctly called all (88/88) weak D types 1, 2 and 3. Review of other 87 apparent discrepancies identified a small number of serology errors and showed that ID RHD XT correctly signalled the presence of other RHD variants which were further confirmed by BDS and BLOODchip® Reference. The predicted HPA-1 phenotype by ID RHD XT was 100% concordant with BDS.

Conclusion: ID RHD XT genotype predictions for high-prevalence RhD negative and weak D types 1, 2 and 3 as well as for HPA-1a/HPA-1b antigens were accurate, which is of clinical significance in guiding transfusion needs.

Keywords: HPA-1; ID RHD XT; RHD; blood group genotyping; sensitivity; specificity.

Publication types

  • Evaluation Study

MeSH terms

  • Alleles
  • Antigens, Human Platelet / genetics
  • Genotyping Techniques / methods*
  • Genotyping Techniques / standards
  • Humans
  • Integrin beta3
  • Rh-Hr Blood-Group System / genetics*

Substances

  • Antigens, Human Platelet
  • ITGB3 protein, human
  • Integrin beta3
  • Rh-Hr Blood-Group System
  • Rho(D) antigen