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

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.

journal_name

Vox Sang

journal_title

Vox sanguinis

authors

Molano A,Apraiz I,España P,Azkarate M,Vesga MÁ,Rubia M,Piedrabuena M,Puente F,Veldhuisen B,van der Schoot E,Tejedor D,López M

doi

10.1111/vox.12701

subject

Has Abstract

pub_date

2018-10-01 00:00:00

pages

694-700

issue

7

eissn

0042-9007

issn

1423-0410

journal_volume

113

pub_type

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