International Accreditation for High Resolution HLA Typing by NGS Sequence for 11 Locis (HLA-A, B, C DRB1, DRB3/B4/B5, DQA1, DQB1, DPA1, DPB1)

Abstract

Introduction: High-resolution HLA typing is required for haplo-identical HLA intrafamilial donors, and for the selection of unrelated donors from international registries and cord blood unit banks. To date, all confirmatory typing
was carried out outside the country, since there was no internationally accredited laboratory to carry out these studies. Since 2017, our institution
began high-resolution HLA typing by NGS sequence with the Illumina Tru-Sight HLA platform; subsequently, with the CareDx AlloSeqTx platform, obtaining accreditation for NGS typing in 2020. Since 2021, we began analyzes with the Miafora platform (Immucor Corp) and this year we have received international accreditation by the European Federation of Immunogenetics
(EFI). for high-resolution HLA analysis by sequence for related intrafamilial donors, and for unrelated donors, both from cord blood units and international donor registries.
Methods: Validation and accreditation of the Miafora HLA 11 Loci platform by NGS was carried out on a MySeq equipment using 10 (retrospective) samples from International Intercomparison tests of the American Society
for Histocompatibility and Immunogenetics (ASHI) program and 20 prospective samples from the same program. The agreement of the results
obtained from the processed samples with the Intercomparison reports issued by ASHI was evaluated.
Results: From a total of 30 samples analyzed (660 loci), concordance was obtained in the typing in the 30 samples processed. However, a discrepancy
in the reporting format was observed at 2 loci (3.3%) because possible ambiguities
in the G-Groups or P-Groups were not taken into account (https://hla.alleles.org/alleles/g_groups.html) in the nomenclature used. Corrective actions were carried out to resolve the points related to nomenclature. International Accreditation for High Resolution HLA Typing by NGS Sequence
was obtained.