PK7300全自动血型分析系统性能使用前确认  

Validation of Beckman PK7300 automatic blood group analysis system

作　　者：王霞 潘彤 刘军 杨文玲 

机构地区：[1]天津市血液中心,天津300110

出　　处：《中国输血杂志》2017年第9期1016-1018,共3页Chinese Journal of Blood Transfusion

摘　　要：目的以Beckman PK7300全自动血型分析系统为例,对全自动血型分析系统的性能的适用性进行确认。方法 1)依据厂家推荐和其他实验室经验选取孵育温度、标本红细胞浓度、标准红细胞浓度、试剂加入量、稀释标本加入量及判定方法等6项参数,与孵育时间、标准抗血清稀释度及标本血浆稀释度等3项待确认参数,同时通过匹配试验进行确认。2)使用血型已知的标本和正反不符及Rh D(-)的特殊标本进行特异性、灵敏度的确认。3)通过与现用微板法进行平行检测进行一致性及可疑率的确认。结果 1)确定本实验室的最佳参数:标准抗血清稀释度为1∶40、标本血浆稀释度为1∶2.5及孵育时间为60 min。2)使用确认后的参数对3 930份ABO血型已知的标本进行检测,判读正确率均>95%,70份Rh D(-)及4份正反不符标本的判读正确率均为100%。3)与微板法的比对,检测结果的一致性>95%,系统检测的总体可疑率<2%。结论待确认的3项主参数与其它参数所构成的检测系统的特异性、灵敏度、一致性及可疑率满足到临床试验要求。Objective To validate the applicability and the capacity of Beckman PK7300 automatic blood group analysis system.Methods According to the recommendations of manufacturers and other laboratories,six parameters,including incubation temperature,reagent red blood cell concentration,sample red blood cell concentration,sample diluents ratio,diluted sample volume,determination parameters,were determined.The other three main parameters（including incubation time,antibodies of standard serum,dilution of sample plasma） were evaluated with matching experiments.The sensitivity and specificity were validated by using known blood types and special samples which consisted of non-conformative forward and reverse typing and Rh D（-） samples.The consistency and suspicious rate were validated by comparing with microplate technique.Results The three main parameters（incubation time,antibodies of standard serum,dilution of sample plasma）were determined as 60 min,1： 40 and 1 ∶2.5,respectively.Using the evaluated parameters,the 3 930 samples with known ABO blood group were performed with forward typing and reverse typing detection.The rates of correct interpretation were 95%.Simultaneously,the 70 cases and 4 cases of special samples were detected correctly.The rate of consistency was 95%and suspicious rate was〈 2% Conclusion The sensitivity,specificity,consistency and suspicious rate of the analysis system can meet the requirements.

关 键 词：全自动血型分析系统 判读正确率 微板法 一致性 可疑率 

分 类 号：R457.11[医药卫生—治疗学]