Quality control of blood components: selection of laboratory testing methods

The blood components transfusion is a significant component of therapy for blood loss, anemia, and surgical operations. One of the main tasks of blood service institutions is the procurement of high-quality transfusion media, the effectiveness of which directly depends on the functioning of the safety system. The implementation of this direction of work is impossible without laboratory testing of the donor biomaterial, a prerequisite for which is the standardization of procedures to ensure the reliability and reproducibility of the results. The aim of this study is to analyze the existing methods for determining hematological parameters and assess their suitability for quality control of blood components. Material and methods. The samples of erythrocyte-containing blood components, fresh frozen plasma, platelet concentrate, as well as reference buffer solutions for pH measurement have been tested. To determine the number of blood cells, conductometry with hydrodynamic focusing, counting in the Goryaev chamber and laser flow cytofluorimetry, were used. The pH indicator was measured by potentiometry. The content of general and free hemoglobin was assessed by photometric, hemiglobincyanide and SLS method. The hematocrit value was determined on a hematological analyzer and by centrifugation in hematocrit capillaries. The activity of factor VIII was checked by the clotting method. Results and discussion. The generalized results of the metrological assessment and a comparative analysis of the listed laboratory methods, taking into account their sensitivity and precision have been presented. Conclusions. A list of recommended methods for quality control of blood components is formed, for each of which an assigned convergence characteristic is established.

1. Federal Law of the Russian Federation of July 20, 2012 No. 125-FZ «On the donation of blood and its components». Available at: http://www.consultant.ru/document/cons_doc_LAW_132904/ [In Russian].

2. Order of the Minzdrav of Russia of October 20, 2020 No. 1170n «On approval of the procedure for providing medical care to the population on the profile «transfusiology»». Available at: https://www.garant.ru/ products/ipo/prime/doc/74865386/ [In Russian].

3. Order of the Minzdrav of Russia of October 26, 2020 No. 1148n «On approval of the requirements for the organization of a safety system for the activities of subjects of circulation of donor blood and (or) its components during the procurement, storage, transportation and clinical use of donor blood and (or) its components». Available at: https://www.garant.ru/products/ipo/prime/doc/74845109/ [In Russian].

4. Resolution of the Government of the Russian Federation of June 22, 2019 No. 797 «On approval of the rules for the procurement, storage, transportation and clinical use of donor blood and its components». Available at: http://www.consultant.ru/document/cons_doc_LAW_328029/ [In Russian].

5. Laboratory methods of quality control of hemotransfusion media in the blood service: Methodological guide. Saint-Petersburg, 2006. 31 p. [In Russian].

6. Nikulina N.S., Kormshchikova E.S., Kalinina E.N., Isaeva N.V., Krivokorytova T.V. Metrological assessment of control the safety of fresh frozen plazma. In: Topical issues of transfusiology, hematologyoncology and cell therapy: to the 60th anniversary of the Kirov Research Institute of Hematology and Blood Transfusion. Kirov: OOO «Flat-Print», 2020. 44–56. [In Russian].

7. Nikulina N.S., Kalinina E.N., Nozdrina E.V., Isaeva N.V., Krivokorytova T.V., Kormshchikova E.S. Metrological evaluation of methods for control the safety indicators of leukoreduced platelet concentrates. Sibirskiy nauchnyy meditsinskiy zhurnal = Siberian Scientific Medical Journal. 2020;40(3):28–33. [In Russian]. doi: 10.15372/SSMJ20200304

8. Nikulina N.S., Kalinina E.N. Metrological evaluation of quality control methods of erythrocytecontaining blood components. Sibirskiy nauchnyy meditsinskiy zhurnal = Siberian Scientific Medical Journal. 2019;39(1):136–141. [In Russian]. doi: 10.15372/ SSMJ20190119

9. Kozyreva V.S., Shilova A.N., Shkoda O.S. Flow cytometry for measuring residual leukocytes in blood plasma. Gematologiya i transfuziologiya = Hematology and Transfusiology. 2019;64(1):66–72. [In Russian]. doi: 10.35754/0234-5730-2019-64-1-66-72

10. Guide to the preparation, use and quality assurance of blood components. Recommendation No. R (95) 15. 20th Edition. Available at: https://www.quotidianosanita.it/allegati/allegato8291904.pdf