摘要
目的探讨输血相容性检测常用试剂性能验证方案,确保试剂性能满足即定要求及检测结果真实准确。方法采用血清学方法验证自制ccDee Oc、RhD(+)Oc、RhD(-)Oc、A型和B型血样、AB血浆致敏红细胞等)及抗体筛选细胞的特异性、血清试剂(抗-A抗-B、抗人球蛋白(抗IgG,C3d)、抗D(IgM)等)的特异性及效价、凝聚胺检测的准确度、细胞试剂(ABO反定)的特异性及凝集强度、质控品(血型和不规则抗体筛查、交叉配血)的特异性及灵敏度等指标,建立输血相容性常用检测试剂性能验证操作规程,明确需验证的情形、种类及关键性能指标和要求。结果除极少数输血相容性检测试剂性能在使用中未通过验证外,大部分试剂重要性能指标均符合即定的标准。结论输血相容性检测常用试剂性能验证方案应尽可能简便、高效地去反映试剂重要性能指标,并易于操作。
Objective To explore the verification scheme of the performance of commonly used reagents in blood transfusion compatibility testing,to ensure that the reagent performance meets the set requirements and the test results are true and accurate.Methods Serological methods were used to verify the specificity of self-made cells[including ccDee Oc,RhD(+)Oc,RhD(-)Oc,RBC A/B type blood samples,AB plasma sensitized RBCs,etc.]and antibody screening cells,the specificity and titer of serological reagents[including anti-A,anti-B,anti-human globulin(anti-IgG,C3 d),anti-D(IgM)],the accuracy of polybrene detection,the specificity and agglutination strength of cell reagents(ABO-specific),specificity and sensitivity of quality control products(blood type and irregular antibody screening,cross matching,etc.).To establish the operational procedures for performance verification of commonly used testing reagents for blood transfusion compatibility,and to clarify the situations,types,key performance indicators and requirements to be verified.Results Except that very few performance of the reagents for transfusion compatibility test have not been verified in use,most of the important performance indexes of the reagents meet the established standards.Conclusion The performance verification scheme of commonly used reagents in blood transfusion compatibility testing should be as simple and efficient as possible to reflect the important performance indicators of reagents and be easy to operate.
作者
高均翠
张敏
卢伟
袁玉荣
郑山根
GAO Juncui;ZHANG Min;LU Wei;YUAN Yurong;ZHENG Shangen(Yichang Red Cross Central Blood Station,Yichang 443005,China;Central Theatre General Hospital)
出处
《中国输血杂志》
CAS
2019年第8期768-772,共5页
Chinese Journal of Blood Transfusion
关键词
输血相容性检测
试剂性能
验证
blood transfusion compatibility testing
reagent performance
verification
