一种国产全自动血库系统的临床应用效果评估

The assessment of a domestic automatic blood bank system and its clinical application

目的评价1种国产全自动血库系统的临床应用效果。方法采用随机配对试验设计,实验组采用国产Aigel 300全自动血库系统和国产某品牌微柱凝胶卡,对照组采用进口某品牌全自动血型仪及其原厂微柱凝胶卡。试验在2个临床试验基地独立完成,在2个基地各检测了临床输血相关标本860例(含常规ABO血型213例、亚型5例、Rh D检测216例、不规则抗体检测210例、交叉配血108组)和814例(含常规ABO血型198例、亚型5例、Rh D检测206例、不规则抗体检测201例、交叉配血102组),在其中1个试验基地还检测了冻存的不规则抗体阳性标本23份,以对照组结果为"参考",分析实验组ABO血型、Rh血型、不规则抗体和交叉配血试验结果的错型率或符合率。结果在其中一个临床试验基地,实验组和对照组的816例对比测试结果全部相符合;在另1临床试验基地,860例的对比测试中,ABO及其亚型、Rh血型、交叉配血结果,实验组与对照组全部符合,但不规则抗体检测在实验组出现1例假阳性,符合率99.52%(209/210)。23份冻存的不规则抗体阳性标本,实验组和对照组各出现1例漏检。结论国产Aigel 300全自动血库系统和微柱凝胶卡,能够满足临床ABO、Rh D血型鉴定、不规则抗体筛选、交叉配血的需求。

Objective To evaluate the effect of a domestic automatic blood blank system on its clinical application.Methods The experimental group consisted of the domestic automatic blood blank system Aigel 300 and domestic micro-column-gel cards,while the control group consisted of WADiana Compact and its original micro-column-gel cards.Tests were implemented in two clinical laboratory trials independently.In one laboratory,860 clinical blood transfusion-related samples（including 213 cases of routine ABO-typing,5 of sub-grouping,216 of Rh D typing,and 210 of irregular antibody screening,and cross-matching 108 pares） were tested.In the other trial,814 clinical samples（including 198 cases of routine ABO-typing,5 of sub-grouping,206 of Rh D typing,201 of irregular antibody screening and 102 of cross-matching） and 23 cryo-preserved irregular antibodies positive samples were tested in comparable setting.The resulting error rate or the consistency in the experimental group was calculated,while using the data from the control group as＂reference＂.Results In one clinical laboratory trial of 814 samples,there was a perfect match between the experimental group and control group.In another clinical trial of 860 samples,routine ABO typing,sub-typing,Rh D typing and cross-matching all showed perfect compatibility,but one false positive was noted in irregular antibody screening,resulting in a consistency of 99.52%（209/210）.For the 23 irregular antibody positive samples,one false negative result was found in experimental group and control group.Conclusion The domestic automatic system Aigel 300 and domestic micro-column-gel cards are comparable to imported products and can meet the requirements for ABO/ Rh D typing,irregular antibody screening and cross-matching.