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

摘要

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 BLOOD chip ? 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 BLOOD chip ? 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.