全自动血型分析系统试验参数的评价与验证  

Evaluation and validation of the applicability of parameters on Beckman PK7300 automatic blood analysis system

作　　者：贾俊杰[1] 王瑞[1] 刘亚庆[1] 陈瑜[1] 姜英[1] 葛红卫[1] 

机构地区：[1]北京市红十字血液中心,北京100088

出　　处：《中国输血杂志》2014年第4期354-357,共4页Chinese Journal of Blood Transfusion

基　　金：卫生部卫生行业科研专项资助项目(201002005)

摘　　要：目的以BECKMAN PK7300全自动血型分析系统为例；评价与验证全自动血型分析系统试验参数在实验室的适用性。方法，在项试验参数（孵育温度、标本红细胞悬液浓度、试剂红细胞浓度、试剂加注量和稀释标本加注量、判定等），采用厂商推荐参数或其他实验室已评价参数；3项试验参数（孵育时间、抗-A抗-B标清稀释比例和标本血浆稀释倍数）运用正交试验原理进行了评价与验证；使用常规标本和特殊血型标本验证试验参数的特异性和灵敏度。结果1）试验参数设置如下：标本／试剂红细胞浓度为1．5％，标本血浆2．5倍稀释、标清1：16倍稀释，相应微孔中加注25μL标本或试剂，在30℃孵育时间45min，以SPC：10—10；P／C：15-30；LIA：300-100进行结果判定。2）使用经评价的试验参数、对2426份已知ABO血型的进行正反定型检测，判读正确率为99．92％。10份A2B亚型：判读正确率为100％。结论9项关键试验参数的特异性好、灵敏度可达到相关要求；对孵育时间和抗-A抗-B标清稀释倍数的筛选，有效提高了检测系统的处理能力和经济效益。Objective To evaluate and validate the applicability of the parameters on Beckman PK7300 automatic blood analysis system in the blood screening laboratory. Methods Aceroding to the recommends of manufacturers and other laboratories, we determined 6 parameters including incubation temperature, reagent volumn, sample diluents ratio, diluted sample volumn, determination parameters and so on. The other 3 parameters （ including incubation time, anti-A and anti-B dilution of standard serum, dilution multiple of sample serum） were evaluated with orthogonal experimental principle. The sensitivity and specificity of detecting system were evaluated and validated by using of conventional and special blood type samples. Results Using the evaluated parameters, the 2 426 samples which known ABO blood group were done forward typing and reverse typing detection. The rate of correct interpretation was 99.92%. Simultaneously, the 10 eases of A2B subtype were detected correctly. Conclusion It indicated that the sensitivity and specificity of detecting system can meet the rele- vant rcquirements, moreover it can effectively improved the processing ability and economic benefits.

关 键 词：血型 全自动血型分析仪 微板法 判读正确率 SPC 

分 类 号：R446[医药卫生—诊断学]