Quality control of HLA typing is a set of measures aimed at ensuring the reliability and comparability of the results of HLA gene determination, including internal and external control. Internal control implies the work of the laboratory in accordance with standard operating procedures, systematic inspection of the laboratory equipment, validation of all newly received reagents, as well as systematic professional development of the staff. External control is the evaluation of the laboratory performance by an outside organization. It includes participation in the Programs of External proficiency Testing (EPT) where laboratories analyze the same samples and the results are compared.
THE AIM OF THIS STUDY
Was to analyze the results of external international quality control of HLA typing in 2023 and 2024 in the Russian Federation.
MATERIALS AND METHODS
During the mentioned period, 15 laboratories of the Russian Federation participated in the international quality control of HLA typing annually. The organizer of the control tests, as well as in previous years (2017—2022) was the Department of Transfusion Medicine of the Medical University of Vienna (Austria), which performs this function on behalf of the European Federation of Immunogenetics. Ten DNA samples isolated from nucleus-containing peripheral blood cells of healthy blood donors were provided for the studies. According to the standards of the European Federation of Immunogenetics, the detection of HLA genes should be performed by all molecular HLA typing methods used in the laboratory. All laboratories that received control samples submitted the results obtained for the determination of HLA allele groups (basic resolution) and (or) allele/allele subgroups (high/allele resolution).
RESULTS
Our analysis showed that in 2023—2024 all Russian laboratories performed low resolution HLA typing successfully, while high resolution HLA typing was demonstrated by 14 laboratories out of 15 corresponding to international quality standards. All laboratories of our country in 2023—2024 have performed typing not only of «obligatory» genes HLA-A, B, DRB1, but also expanded their results with information about genes HLA-C, DQB1, besides, in 2023—2024, 6 and 7 laboratories, respectively, performed typing of six genes, including the HLA-DPB1 gene in the study.
CONCLUSION
The analysis shows a positive trend in the development of immunogenetic studies in our country — the absence of errors in low resolution HLA typing, which is widely demanded in our country during organ transplantation, as well as the expansion of the range of HLA genes determined, which is extremely important in hematopoietic stem cell transplantation (HSCT). The presence of isolated errors when performing high resolution HLA-typing certainly requires analysis of the causes of these errors and additional training of the staff.
