非配套PK7300型全自动血型检测系统方法的建立与评价  

Establishing and validating the non-matched standard system of Beckman PK7300 automatic blood analysis system

作　　者：杨忠思 周华友[2] 冯秋霞 潘海平 

机构地区：[1]青岛市中心血站,山东青岛266071 [2]南方医科大学南方医院

出　　处：《中国输血杂志》2017年第11期1228-1231,共4页Chinese Journal of Blood Transfusion

基　　金：国家高技术研究发展计划(863计划)(2013AA020201)

摘　　要：目的建立并评价针对全自动血型分析系统BECKMAN PK7300的非配套检测系统方法。方法参照厂商推荐参数及其他文献方法对孵育温度、试剂加注量和稀释标本加注量做优化测试;运用正交试验原理对标本血浆的稀释浓度、标本红细胞的稀释浓度,抗-A和抗-B血型定型试剂、Rh D定型试剂的稀释浓度以及试剂红细胞的稀释浓度做评价与验证。结果获得非配套K7300全自动血型检测系统的各项参数:1)正定型检测:标本红细胞稀释浓度1.5%、抗-A、抗-B血型定型试剂稀释浓度1∶40和(或)1∶4;2)反定型检测:标本血浆稀释浓度1∶2.5、试剂红细胞稀释浓度1∶2;3)Rh血型检测:标本红细胞稀释浓度1.5%、Rh D血型定型试剂稀释浓度1∶40;4)孵育时间60 min、孵育温度30℃,标本反应体积25μL、试剂反应体积25μL。结论成功建立了非配套PK7300型全自动血型检测系统,评价结果显示该检测系统特异性好、灵敏度,可满足相关检测要求;通过对标本和试剂稀释倍数的筛选,提高了非配套PK7300全自动血型检测系统的准确性和有效性。Objective To meet the requirements of Beckman PK7300 automatic blood analysis system,we built a nonmatched standard analysis system protocol and validated it in the following aspects： dilution of sample serum,dilution of sample red blood cell,dilution of standard anti-A and anti-B serum,dilution of Rh reagents and dilution of standard RBC.Methods According to the recommends of manufacturers and the methods in several publications,we optimized 3 parameters including incubation temperature,reagent volume and the diluted sample volume. With the orthogonal experimental principle,we evaluated the following aspects： The dilution rate of the sample serum,the dilution rate of the sample red blood cell,the dilution rate of standard anti-A and anti-B serum,the dilution rate of Rh reagents and the dilution rate of standard RBCs. Results We built a non-matched standard analysis system and acquired the parameters mentioned prior. The parameters we obtained are as follows： 1. The dilution rate of the sample red blood cell was 1. 5%,the dilution ratio of standard anti-A and anti-B serum were 1 ∶40 and 1 ∶4 respectively; 2. The dilution rate of the sample serum was 2. 5 times,the dilution ratio of standard RBCs was 1 ∶2; 3. Rh blood group testing： The dilution rate of standard RBC was 1.5%,the dilution ratio of Rh reagents was 1 ∶40; 4. The incubation time was 60 minutes,the incubation temperature was 30℃,the sample volume was 25 μl and the reagent reaction volume was 25 μL. Conclusion A non-matched standard analysis system of the Beckman PK7 300 automatic blood analysis system has been built. The 7 key parameters in this system presented good sensitivity and specificity which meets the relevant requirements. Moreover, it could effectively promote the processing capability,gain extra economic benefits and reduce the manual verification labor.

关 键 词：血型 全自动血型分析仪 稀释浓度 微板法 非配套检测方法 判读正确率 

分 类 号：R457.11[医药卫生—治疗学] R446[医药卫生—临床医学]