Analysis of influencing factors on hemolysis rate at the end of storage period of leukocyte-reduced red blood cells and exploration of quality control standards

Corresponding author: HAN Xiaoyan, lvgb13@163.com

DOI: 10.12201/bmr.202603.00002

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  Abstract: Objective By analyzing the hemolysis rate and related quality control indexes at the end of storage period of leucocyte-reduced red blood cells in our blood station during the past 5 years, the influence factors of donors on various quality control indexes were explored, and the appropriate internal control standard of hemolysis rate at the end of storage period in our area was established. Methods A total of 246 leucocyte-reduced red blood cell suspension products were collected from January 2021 to November 2025, hemoglobin concentration (Hb), hematocrit (Hct) and supernatant free hemoglobin concentration (FHb) were detected, hemolysis rate at the end of storage period was calculated, and compared with the current Quality Requirements for Whole Blood and Blood Components.(GB18469 -2012), and analyze the difference of hemolysis rate at the end of storage; Analyzing the influencing factors of various indicators based on the population structure of blood donors. Results The average hemolysis rate of leucocyte-reduced red blood cells at the end of 5 years storage was 0.071±0.039, far lower than the national standard of 0.8%. Sex, age, occupation and blood type had no statistical significance on the hemolysis rate at the end of storage. The sex of blood donors was Hb.(P<0.01), Hct (P<0.01) and FHb (P<0.05) were male group> female group; The hemolysis rate data at the end of storage for all samples were <0.4%, and 95% of the samples were before 0.137%. Conclusion The results of data analysis of 246 samples showed that the sex of blood donors was the influential factor of Hb, Hct and FHb, and the hemolysis rate at the end of storage period was not affected by the sex, age, occupation and blood group of blood donors. The current national standard of hemolysis rate <0.8% at the end of storage period of leucocyte-reduced red blood cells is too large for this region. Therefore, quality control indexes suitable for this region can be considered. Setting the internal control standard of hemolysis rate <0.3% will be more conducive to blood quality control and blood quality safety in this region.

  Key words: Leucocyte-reduced red blood cells; Hemolysis rate at the end of storage period; Internal control standard; Quality control

  Submit time: 2 March 2026

  Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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