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

作　　者：常乐[1] 闫颖[1] 姬慧敏 孙慧珍 王露楠[1] CHANG Le;YAN Ying;JI Huimin;SUN Huizhen;WANG Lunan(National Center for Clinical Laboratories,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing Hospital/National Center of Gerontology,Beijing 100730,China)

机构地区：[1]北京医院国家老年医学中心、国家卫生健康委临床检验中心、中国医学科学院老年医学研究院,北京100730

出　　处：《中国输血杂志》2025年第4期465-473,共9页Chinese Journal of Blood Transfusion

基　　金：中国医学科学院医学与健康科技创新工程项目(2021-I2M-1-060)。

摘　　要：目的获得我国献血人群丙氨酸氨基转移酶(alanine aminotransferase,ALT)水平的真实数据和探讨调整ALT合格标准的必要性。方法联合全国26家血液中心和7家年检测量>10万人份的中心血站,在2024年12月1—15日,选择1~2 d对所有全血捐献标本停止采前ALT检测,仅在采集后进行ALT实验室检测,并使用实验室常规检测设备和试剂完成所有常规输血传播病原体标志物的血清学检测和核酸检测项目,同时增加戊型肝炎病毒(hepatitis E virus,HEV)核酸检测,在检测完成后1周内收集整理此时间段内所有全血献血者匿名的基本信息、常规检测项目检测结果、HEV核酸检测结果等信息,汇总后进行统计分析。结果本研究共纳入献血者21345人,ALT不合格率为7.6%(1623/21345),其中男性不合格率为9.6%(1453/15205),女性为2.8%(170/6140)。不同地区ALT不合格率和量值水平差异较大,陕西省不合格率最高(12.3%)(87/710),云南省不合格率最低(2.9%)(19/652),北京市在各省间ALT量值水平最低。在不同性别献血者中,不同年龄组献血者ALT水平量值呈现不同的变化。所有开展HEV核酸检测的21003名献血者中,HEV核酸阳性率为0.29‰(6/21003)。HCV感染可直接影响ALT量值水平,而HBV、HIV、梅毒螺旋体和HEV感染未发现会影响ALT不合格率。若将ALT合格标准调整至临床正常值参考区间上限的2倍,可放行血液人份数将提升6.61%(1293/19550)。结论我国献血者ALT水平与性别、年龄、地域及是否感染HCV有关,适当向上调整ALT合格标准至男性献血者≤100 U/L和女性献血者≤80 U/L,可在保证血液安全的前提下,扩大合格献血者范围和降低血液报废率。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 100000 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 results were collected and statistically analyzed.Results A total of 21345 blood donors were included in the study,with an ALT disqualification rate of 7.6%(1623/21345).The disqualification rate was 9.6%(1453/15205)for males and 2.8%(170/6140)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‰(6/21003).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%(1293/19550).Conclusion In China,the ALT levels of blood donors are correlated with gender,age,geographical region,and HCV infection status.Appropriately raising the ALT eligibility criteria to�

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 

分 类 号：R457.1[医药卫生—治疗学] R446.6[医药卫生—临床医学]