出 处:《中国输血杂志》2024年第9期1042-1046,共5页Chinese Journal of Blood Transfusion
摘 要:目的本研究旨在建立本中心去白细胞悬浮红细胞容量内部质量控制标准,以指导成分制备,加强内部质控,提高血液制剂的质量。方法抽取本中心2023年3-8月使用2个厂家去白细胞型塑料血袋采集的全血1523袋,分别称取过滤前及过滤后的重量,依据公式及测定的比重计算全血采集量、过滤损耗容量及产品容量。依据数据分布特征确定去白悬浮红细胞容量参考范围,分析全血采集量、过滤损耗容量及产品容量在两个厂家之间的差异。比较近一年去白细胞悬浮红细胞质控容量数据及另抽取的100袋去白细胞悬浮红细胞与参考区间的差异,验证参考区间的有效性。结果样本总体全血采集量中位数为402.0 mL,过滤损耗容量中位数为41.4 mL;去白悬浮红细胞容量均数为322.5 mL,其中使用厂家A去白细胞型塑料血袋的全血采集量(A:中位数404.4 mL;B:中位数397.7 mL,P<0.01)及去白悬浮红细胞产品容量(A:均值331.4 mL;B:均值312.0 mL,P<0.01)均更高,且过滤损耗容量更低(A:中位数39.5 mL;B:中位数46.6 mL,P<0.01);去白悬浮红细胞容量数据标准差为19.6,则去白悬浮红细胞容量参考区间为284.1~360.9 mL。验证样本及质控抽检数据均与区间样本无差异(P>0.05)。结论根据实际情况,将本中心去白细胞悬浮红细胞的容量标准确定为284.1~360.9 mL。Objective To establish the internal quality control standard of leukocyte-depleted suspended red blood cell volume in our center,so as to guide the preparation of components,strengthen the internal quality control and improve the quality of blood preparations.Methods A total of 1523 bags of whole blood collected using two manufacturers′leukocyte-depleted blood bags from March to August 2023 at our center were extracted.The blood before and after filtration were weighed,and the volume of whole blood collected,the volume of filtration loss and the product volume based on the formula and measured specific gravity were calculated.According to the data distribution characteristics,the reference range of leukocyte-depleted suspended red blood cell volume was determined,and the differences of whole blood collection volume,filtration loss capacity and product capacity between the two manufacturers were analyzed.The quality control data of leukocyte-depleted red blood cells over the past year with the difference between another 100 bags of these cells and the reference interval were compared,and the effectiveness of reference interval was validated.Results The median whole blood collection volume in the sample size was 402.0 mL,with a median filtration loss of 42.4 mL,and an average volume of leukocyte-depleted suspended red blood cells at 322.5 mL.The whole blood collection volume(A:median 404.4 mL;B:median 397.7 mL,P<0.01)and the volume of leukocyte-depleted suspended red blood cell products(A:mean 331.4 mL;B:mean 312.0 mL,P<0.01)using manufacturer A′s leukocyte-depleted blood bag were both higher,with a lower filtration loss capacity(A:median 39.5 mL;B:median 46.6 mL,P<0.01).The standard deviation of the volume of leukocyte-depleted suspended red blood cell was 19.6,and the reference interval was 284.1-360.9 mL.The validation samples and quality control sampling data showed no difference from the interval samples(P>0.05).Conclusion According to the actual situation of our center,the volume standard of leukocyte-dep
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