全自动血型仪性能优化方案探索及献血者结果分析  

Exploration of Performance Optimization Scheme for Fully Automatic Blood Type Analyzer and Analysis of Blood Donor Results

作　　者：蒋慧[1] 陈明军[1] 李丹[1] JIANG Hui;CHEN Mingjun;LI Dan(Henan Red Cross Blood Center,Zhengzhou 450052,China)

机构地区：[1]河南省红十字血液中心,河南郑州450052

出　　处：《河南医学研究》2024年第11期2049-2052,共4页Henan Medical Research

摘　　要：目的 探索更科学、有效的血型检测设备性能验证方法,对使用年限较长、维修过的甲设备进行性能验证并优化。方法 甲、乙(已确认)两台设备同时进行4 026份献血员样本的平行比对实验,并以试管法作为补充对照实验方法。根据实验结果的符合率评价甲设备的性能,并适当调整甲设备ABO、Rh(D)血型检测的部分参数。通过效价测定确保甲设备抗原抗体检测的凝集强度与乙设备相当,并使用优化后的实验参数进行再次平行比对实验。结果 两种设备总符合率99.80%,Rh(D)血型符合率100%,ABO血型符合率99.98%,经血型研究室确认,共检出3例亚型:甲设备弱抗体、弱抗原漏检各1例,乙设备漏检弱抗原1例。脂血溶血样本甲设备未检出1例,乙设备未检出6例。甲设备、乙设备、试管法的抗-A、抗-B效价分别为8、32、128,抗-D效价分别为2、8、64。通过调整设备参数提高凝集效价。相关实验参数优化后,400份献血员标本比对总符合率为100%。结论 采供血机构关键设备维修后的性能验证是实验室质量管理体系的一部分。性能比对实验及多参数的优化提高了甲设备抗原/抗体的检测能力。Objective To explore more scientific and effective methods for verifying the performance of blood type testing equipment,and optimize the performance of a equipment that has been used for a long time and has been repaired.Methods Two sets of instruments were used to conduct parallel comparison experiments on 4026 blood donors.And the test tube method was used as a supplementary control experimental method.The performance of equipment A based on the compliance rate of experimental results was evaluated,and adjusted some parameters of ABO and Rh(D)blood type detection of equipment A appropriately.The agglutination strength of antigen antibody detection on device A was equivalent to that of device B was ensured through potency testing,and parallel comparison experiments was conducted by optimized experimental parameters.Results The results showed that the total coincidence rate of the two equipments was 99.80%,Rh(D)was 100%,ABO was 99.98%.Reference lab confirmed that there were 3 subgroups discovered,2 subgroups were missed by A equipment,1 subgroup was missed by B equipment.One case hemolytic/chylous specimen was missed by A equipment,six cases was missed by the B equipment.Anti-A/B titers of A equipment,B equipment and test-tube method were 8,32 and 128,respectively,anti-D titers were 2,8,64,respectively.The agglutination titer was increased by adjusting equipment parameters.After the twice parameter adjustment,the total coincidence rate of 400 blood donors was 100%.Conclusion The performance verification of key equipment in blood collection and supply institutions is part of the laboratory quality management system.After parameter adjustment,the detection titer and the detection ability of equipment A for weak antigen/antibody were improved.

关 键 词：全自动血型分析仪 ABO血型 RH(D)血型 性能验证 

分 类 号：R446.9[医药卫生—诊断学]