中国输血杂志2025，Vol.38Issue(4)：465-473,9.DOI:10.13303/j.cjbt.issn.1004-549x.2025.04.002
我国血液筛查丙氨酸氨基转移酶现行合格标准调整分析
Analysis of the adjustment of current eligibility criteria for alanine aminotransferase levels in blood screening in China
摘要
Abstract
Objective To obtain accurate data on alanine aminotransferase(ALT)levels among blood donors in China and to explore the necessity of adjusting the qualification criteria for ALT.Methods A collaborative study was conducted involving 26 blood centers and 7 central blood stations with an annual testing volume exceeding 100 000 samples.Between December 1 and 15,2024,pre-donation ALT testing was suspended for 1-2 days for all whole blood donations.ALT levels were measured only post-donation using standard laboratory equipment and reagents.All transfusion-transmitted infectious disease-related serological and nucleic acid testing,including hepatitis E virus(HEV)RNA testing,were performed.Within one week of testing completion,anonymized data on basic donor information,routine test results,and HEV RNA re-sults were collected and statistically analyzed.Results A total of 21 345 blood donors were included in the study,with an ALT disqualification rate of 7.6%(1 623/21 345).The disqualification rate was 9.6%(1 453/15 205)for males and 2.8%(170/6 140)for females.There were significant regional variations in both the disqualification rates and levels of ALT,with Shaanxi Province exhibiting the highest disqualification rate(12.3%,87/710)and Yunnan Province the lowest(2.9%,19/652).Among the provinces(autonomous regions and municipalities),Beijing recorded the lowest ALT levels.ALT levels varied across different age groups and genders.Among all samples tested by HEV RNA,the HEV RNA positive rate was 0.29‰(6/21 003).HCV infection was found to directly affect ALT levels,while HBV,HIV,syphilis,and HEV infections did not significantly impact ALT disqualification rates.It is recommended to adjust the ALT qualification criteria to twice the upper limit of the clinical reference range,which would increase the number of eligible blood donations by 6.61%(1 293/19 550).Conclusion In China,the ALT levels of blood donors are correlated with gender,age,geo-graphical region,and HCV infection status.Appropriately raising the ALT eligibility criteria to≤100 U/L for male donors and≤80 U/L for female donors could expand the pool of eligible donors and reduce the blood discard rate while ensuring blood safety.关键词
献血者/丙氨酸氨基转移酶/戊型肝炎病毒/血站/合格标准Key words
blood donor/alanine aminotransferase(ALT)/hepatitis E virus(HEV)/blood establishments/qualifica-tion criteria分类
临床医学引用本文复制引用
常乐,闫颖,姬慧敏,孙慧珍,王露楠..我国血液筛查丙氨酸氨基转移酶现行合格标准调整分析[J].中国输血杂志,2025,38(4):465-473,9.基金项目
中国医学科学院医学与健康科技创新工程项目(2021-I2M-1-060) （2021-I2M-1-060）
