Organization of the HLA-typing laboratories

HLA typing is a laboratory test that allows to determine HLA antigens or HLA genes of a specific individual. The purpose of this article is to summarize the principles of organizing HLA laboratories, requirements for laboratory personnel, quality management, handling of biological material and standardization of laboratory equipment. Materials and methods. To achieve this goal, we analyzed the current domestic and international regulatory documents, as well as the main scientific publications of the last 5 years. Results. This article provides a detailed description of the general principles of organizing HLA laboratories, including requirements for the education and work experience of personnel, regular advanced training of personnel; management requirements, including maintaining an up-to-date fund of standard operating procedures; control of the correctness of the results obtained through a set of activities for internal laboratory quality control; a system of external quality control of HLA typing; a system of control over the maintenance of equipment in good condition, a system of quality control and continuous monitoring of the reagents used; prevention of conflicts of interest and ensuring the independence of research results from any pressure; regular internal audits of all work processes. The requirements for standardization of laboratory equipment and handling of biological material are also set out. Conclusion. A laboratory performing HLA typing is a complex system, the work of which involves many elements: personnel, infrastructure, technological processes, equipment, work methods, documentation, etc. The quality system of the HLA laboratory is ensured by the interconnectedness and interaction of all the above elements, which must be coordinated. The application of the presented requirements to the organization of HLA laboratories can contribute to increasing the efficiency and optimization of their activities, which, in turn, will improve the efficiency of selecting donor-recipient pairs for transplantation, determining diagnostically significant immunogenetic characteristics.