OID-07. Quality control of HLA typing in Russian laboratories over the period of 2017-2021
Irina E. Pavlova, Elena V. Kuzmich, Lyudmila N. Bubnova
Russian Research Institute of Hematology and Transfusiology, Federal Medical and Biological Agency, St. Petersburg, Russia
Contact: Dr. Irina E. Pavlova, phone: +7 (921) 983-66-64, e-mail: email@example.com
Current trends in allogeneic hematopoietic stem cell transplantation (allo-HSCT) development require mandatory immunogenetic testing (HLA-typing) of donors and recipients in order to enable the optimal donor selection for a particular patient. Therefore, the effective work of HLA laboratories is crucial to allo-HSCT success. Every year several HLA-laboratories from Russian Federation participate in international procedure of External proficiency testing (EPT) implementation for external quality control of HLA typing conducted by European Federation for Immunogenetics (EFI) since there are currently no domestic (all-Russian) external control programs. The purpose of this work is analyzing the international procedure of External Proficiency Testing (EPT) effectiveness in Russian laboratories.
Materials and methods
For the period from 2017 to 2021 a total of 10 to 16 laboratories from Russian Federation took part in annual EPT (the largest number was registered in 2019), which amounts to 25.6%-45.5% of the total number of participants.
The minimal requirements for external quality control (HLA-A*, -B*, -DRB1* typing at low-resolution level) were performed only by some laboratories over a limited time period from 2017 to 2019. The majority of laboratories (57.1%-66.7%) over the past five years have presented the HLA typing results for 5 loci (HLA-A, B, C, DRB1, DQB1) at high or allelic level resolution. The HLA-DRB1 and -DQA1 loci were studied by single laboratories. About a third of laboratories (26.7%-30%) completed their external quality control program to the maximum reporting results from both low and high resolution or allelic HLA-typing. Also, 2 to 15 discrepancies were registered in laboratories while performing HLA-typing at the low resolution level (the most frequent discrepancies were revealed at the HLA-A and -C loci) except 2020, when all laboratories completed the EPT without discrepancies. The number of annual discrepancies varied from 5 to 11 in high-resolution or allelic HLA-typing (the most frequent discrepancies were revealed in HLA-DRB1 locus typing). According to the criteria of EPT assessment, 11.1%-28.6% of Russian laboratories failed to complete low resolution HLA-typing during 2017-2019. Only in 2020 and 2021 the results of all laboratories were satisfying. Successful implementation of high-resolution HLA typing by all participants from the Russian Federation was noted only once in 2018. The EPT results from 11.1% to 33.3% of laboratories were dissatisfying during remaining four years of observation.
The results of the analysis indicate the need of development and implementation of a national external HLA-typing quality control system and organization of continuous education for specialists of HLA-laboratories. This will increase the efficiency of laboratories, both in donor-recipient pairs selection and in hematopoietic stem cell donors registries development.
HLA-typing, quality control, laboratory.