A unified design for validation of methods for quality control of blood components
https://doi.org/10.18699/SSMJ20230108
Abstract
Quality assurance of transfusion media is a fundamental principle of the functioning of all blood service institutions, allowing guaranteeing the safety of the recipient. An integral part of the procuring process of blood components is their laboratory testing, which results reliability and reproducibility can be proved by carrying out of validation of analytical methods. The aim of the study was to define the rules for planning and carrying out validation tests of methods for quality control of blood components, including verification of their compliance with established acceptance criteria. Material and methods. The analysis of the literature about the safety of blood components and the quality of laboratory tests was carried out with an assessment of the applied significance of the information proved. Results and discussion. As a result of the work done, a unified model for confirming of the accuracy of determining of the safety indicators of transfusion media was created, which contributes to improving of the quality of donor biomaterial and the effectiveness of therapy. Conclusions. The presented validation design is relevant for medical organizations working in the sphere of blood donation and its components.
About the Authors
E. N. Kalinina
Kirov Research Institute of Hematology and Blood Transfusion of FMBA of Russia
Russian Federation
Russian Federation
Elena N. Kalinina
610027, Kirov, Krasnoarmeyskaya str., 72
E. S. Kormshchikova
Kirov Research Institute of Hematology and Blood Transfusion of FMBA of Russia
Russian Federation
Russian Federation
Elena S. Kormshchikova
610027, Kirov, Krasnoarmeyskaya str., 72
N. S. Vildanova
Kirov Research Institute of Hematology and Blood Transfusion of FMBA of Russia
Russian Federation
Russian Federation
Nataliya S. Vildanova
610027, Kirov, Krasnoarmeyskaya str., 72
F. S. Sherstnev
Kirov Research Institute of Hematology and Blood Transfusion of FMBA of Russia
Russian Federation
Russian Federation
Filipp S. Sherstnev, candidate of medical sciences
610027, Kirov, Krasnoarmeyskaya str., 72
References
1. 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].
2. Order of the Ministry of Health of the Russian Federation 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].
3. Guide to the preparation, use and quality assurance of blood components. European Directorate for the Quality of Medicines & HealthCare. 2020. Recommendation No. R (95) 15, 20th Edition. Available at: https://www.quotidianosanita.it/allegati/allegato8291904.pdf
4. Order of the Ministry of Health of the Russian Federation of February 07, 2000 No. 45 «On the system of measures to improve the quality of clinical laboratory tests in healthcare institutions of the Russian Federation». Available at: https://medica-n.ru/wpcontent/uploads/2018/03/Prikaz-45-ot-07.02.2000.pdf [In Russian].
5. Order of the Ministry of Health of the Russian Federation of May 26, 2003 No. 220 «On approval of sector standard “Rules for carrying out in-laboratory quality control of quantitative methods of clinical laboratory tests using control materials’’. Available at: https://medica-n.ru/wp-content/uploads/2018/03/Prikaz-220-ot-26.05.2003.pdf [In Russian].
6. International standard ISO 5725-2:2019 «Accuracy (trueness and precision) of measurement methods and results: Basic method for the determination of repeatability and reproducibility of a standard measurement method». International Organization for Standardization. Available at: https://www.sis.se/api/document/preview/80018860/
7. Kozyreva V.S., Shilova A.N., Shkoda O.V. 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
8. 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. Topical issues of transfusiology, hematology oncology and cell therapy: to the 60th anniversary of the Kirov Research Institute of Hematology and Blood Transfusion: proc. conf., Kirov, 01–02.10.2020. Kirov: Flat-Print, 2020. P. 44–56. [In Russian].
9. Nikulina N.S., Kalinina E.N. Metrological evaluation of quality control methods of erythrocytecontaining blood components. Sibirskij nauchnyj medicinskij zhurnal = Siberian Scientific Medical Journal. 2019;39(1):136–141. [In Russian]. doi: 10.15372/SSMJ20190119
10. 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. Sibirskij nauchnyj medicinskij zhurnal = Siberian Scientific Medical Journal. 2020;40(3):28–33. [In Russian]. doi: 10.15372/SSMJ20200304
11. Kalinina E.N., Vildanova N.S., Kormshchikova E.S., Konovalova E.A., Isaeva N.V., Krivokorytova T.V., Kovtunova M.E., Vorobiev K.A. Quality control of blood components: selection of laboratory testing methods. Sibirskij nauchnyj medicinskij zhurnal= Siberian Scientific Medical Journal. 2022;42(1):56– 61. [In Russian]. doi: 10.18699/SSMJ20220106
12. OFS.1.1.0012.15 “Validation of analytical methods”. In: State Pharmacopoeia of the Russian Federation. XIV-th ed. Vol. 1. Moscow, 2018. P. 276– 288. [In Russian].
13. OFS.1.1.0013.15 “Statistical processing of the results of a chemical experiment”. In: State Pharmacopoeia of the Russian Federation. XIV-th ed. Vol. 1. Moscow, 2018. P. 289–318. [In Russian].
14. ICH Harmonized Tripartite Guideline “Validation of analytical procedures: text and methodology”. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Q2(R1), 2005. Available at: https://www.fptl.ru/biblioteca/validaciya-metodik/ICH_Q2-R1_guideline.pdf
15. OFS.1.2.1.0004.15 “Ionometry”. In: State Pharmacopoeia of the Russian Federation. XIV-th ed. Vol. 1. Moscow, 2018. P. 532–541. [In Russian].
Review
Views:
337
Email this article 