输血相容性检测室内质控品的临床应用评价

目的评价解放军总医院输血科自主研发的输血相容性检测室内质控品临床应用效果。方法回顾性分析2009年10月～2011年10月全国31家输血相容性检测实验室应用该室内质控品对ABO及RhD血型鉴定试验、不规则抗体筛查试验和交叉配血试验开展室内质量控制工作情况,分析该室内质控品检测结果的重复性和稳定性;根据各实验室应用的试验方法、试剂、耗材及试验结果,分析室内质控品在各种检测条件下的实际应用效果。结果 31家输血相容性检测实验室共完成室内质控试验14 271次,包括ABO及RhD血型鉴定试验4 552次、不规则抗体筛查试验4 539次及交叉配血试验5 180次,失控7次。ABO及RhD血型鉴定试验A、B、D抗原检测结果变异系数(CV)为0;ABO血型鉴定反定型试验、不规则抗体筛查试验及交叉配血试验抗原、抗体反应阴性结果的CV为0,抗原、抗体反应阳性结果均为CV<10.0%;质控品不同保存时间试验结果比较差异甚小(P>0.05)。结论研发的自制室内质控品在重复性、稳定性方面可以满足输血相容性检测室内质量控制的基本要求。

Evaluation of internal quality control products for blood transfusion compatibility testing

Objective To evaluate the clinical application effect of internal quality control products for blood transfusion compatibility testing,and the products were independently developed by Chinese PLA General Hospital,Department of Blood Transfusion.Methods The situation of using internal quality control products for IQC of ABO and RhD blood group testing,irregular antibody screening and crossmatch testing in 31 Blood Transfusion Compatibility Testing Laboratories from Oct.2009 to Oct.2011 were analyzed,retrospectively.The repeatability and stability of the testing results was also evaluated.Meanwhile,the basis of tests method,reagents,materials and results in each laboratory,practical application effect of the products in all kinds of conditions were analyzed.Results The 31 Blood Transfusion Compatibility Testing Laboratories have completed 14 271 IQC tests,which including 4 552 ABO and RhD blood group IQC testing,4 539 irregular antibody screening IQC testing and 5 180 crossmatch IQC testing,and 7 results of IQC testing were out of control.CV were 0 in ABO and RhD forward blood group testing of antigen A,antigen B and antigen D response results.In ABO and RhD reverse blood group testing,irregular antibody screen testing and crossmatch testing about antigen and antibody,CV of the negative results of IQC products were 0,and CV of positive results of IQC products were all less than 10.0%.Compare the quality control product results of different save times,there was no significant statistically difference.(P > 0.05) Conclusion The products which researched by our department can meet the elementary requirements in repeatability and stability of blood transfusion compatibility testing IQC.