献血者丙氨酸氨基转移酶筛查检测结果分析与质量管理措施  

Analysis of alanine aminotransferase screening results in blood donors and quality management measures

作　　者：臧亮[1] 周磊[1] 常乐[2] 王露楠[2] ZANG Liang;ZHOU Lei;CHANG Le;WANG Lunan(Dalian Blood Center,Dalian 116001,China;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]大连市血液中心,辽宁大连116001 [2]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474-481,共8页Chinese Journal of Blood Transfusion

摘　　要：目的通过对采血前不同初筛方法和不同来源标本的献血者丙氨酸氨基转移酶(ALT)检测结果进行分析,探讨ALT检测过程中的质量问题以及质量管理措施,以提升ALT检测结果的一致性和准确性。方法选取全国58家采供血机构,比较使用干式生化仪、半自动生化仪和全自动生化仪对献血者标本进行ALT检测的结果,分析静脉血与末梢血标本来源对检测准确性的影响。通过对比采血前初筛检测和实验室检测结果,评估不同方法和标本来源下的质量管理现状,结合实验室之间的不合格率差异,提出质量改进策略。结果采用不同检测方法进行采血前ALT初筛检测时,静脉血和末梢血标本的实验室ALT检测不合格率均无差异(P>0.05)。无论采用哪种检测方法,ALT实验室检测不合格率,静脉血组均低于末梢血组(P<0.05)。各采供血机构实验室之间的质量控制差异较大(P<0.05)。结论采血前3种方法ALT初筛检测结果与实验室检测结果差异不大,血站可根据实际情况选择适合的检测方法;采血前采用静脉血标本在检测的质量控制上相较于末梢血更为可靠。各血站之间ALT检测不合格率存在明显差异,建议采供血机构应重视采血前初筛和实验室检测环节的质量管理,通过优化标准化操作、定期进行设备校准和维护、能力验证、室内质控、检测系统的比对,以及加强人员培训和考核等措施,确保筛查结果的稳定性和一致性,降低ALT检测的不合格率。Objective To explore quality issues and quality management measures in alanine aminotransferase(ALT)testing,aiming to improve consistency and accuracy of ALT test results by analyzing the outcomes from different pre-donation screening methods and different sample sources.Methods Data were collected from 58 blood collection and supply institutions across China.ALT test results from donor samples analyzed by dry chemistry analyzers,semi-automatic biochemical analyzers,and automatic biochemical analyzers were compared,focusing on the influence of venous versus capillary blood samples on testing accuracy.By comparing results from pre-donation screening with laboratory testing,the current state of quality management for different methods and sample types was assessed.Differences in ALT unqualified rates between laboratories were analyzed,and quality improvement strategies were proposed accordingly.Results No significant differences were found in laboratory ALT unqualified rates between venous and capillary blood samples during pre-donation screening across different analytical methods(P>0.05).However,laboratory ALT unqualified rates were consistently lower for venous blood compared to capillary blood,regardless of the testing method used(P<0.05).Notable differences in quality control were observed among various blood collection and supply institutions(P<0.05).Conclusion Minimal differences were observed between pre-donation ALT screening results obtained by the three analytical methods and laboratory test outcomes;thus,blood stations can select an appropriate testing method according to their specific conditions.Pre-donation screening using venous blood samples demonstrated superior reliability in quality control compared to capillary blood samples.Significant variations in ALT unqualified rates among blood stations suggest that blood collection and supply institutions should emphasize quality management at both the pre-donation screening and laboratory testing stages.Measures such as optimized standardized operating

关 键 词：丙氨酸氨基转移酶 采前筛查 质量管理 献血者 

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