血站两套全自动酶免分析系统检测HBsAg性能比对分析  

Comparison and Analysis of the Performance of Two Sets of Automatic ELISA Systems of the Blood Station in Detecting HBsAg

作　　者：赵苏南 许丹丹 曹瑜 ZHAO Su-nan;XU Dan-dan;CAO Yu(Department of Laboratory Medicine,Lianyungang Red Cross Central Blood Station,Jiangsu Lianyungang 222001)

机构地区：[1]连云港市红十字中心血站检验科,江苏连云港222001

出　　处：《中国医疗器械信息》2021年第22期10-11,57,共3页China Medical Device Information

摘　　要：目的:通过HBsAg检测,对本实验室两套全自动酶免分析系统进行仪器设备间的性能和差异比较。方法:固定相同实验人员、试剂、方法、环境,设计4个随机的实验组对常规无偿献血者标本、弱阳性质控血清、国家卫健委临检中心室间质量评价(EQA)标本进行HBsAg检测。对比不同实验组标本检测的特异性和敏感性、检测结果正确率、弱阳性质控品S/CO值批内均值(X)、标准差(S)和变异系数(CV)。采用χ^(2)检验和Kappa检验等评价不同实验组定性检测性能的差异及一致性。结果:4个随机的实验组检测结果特异性(50/50),敏感性均(35/35),结果一致性(85/85),正确率(85/85)均为100%。HBsAg质控检测结果批内CV均<7%,符合15%以内的可接受标准。经χ^(2)检验4个实验组两套仪器设备间的检测一致性为优,差异无统计学意义(P>0.05)。结论:两套全自动酶免分析系统检测HBsAg结果具有一致性,血站血液筛查实验室可以通过无偿献血者标本、弱阳性质控品和室间质评样本检测结果相结合对比分析的方式,对设备之间的性能和差异进行比较。Objective:Through HBsAg detection with the two sets of automatic ELISA systems in our laboratory,to compare the performance and differences between instruments and equipment.Methods:Fixed the same experimental personnel,reagents,method and environment,4 random experimental groups were designed to conduct HBsAg detection for samples of routine unpaid blood donors,weak positive serum standard panel,and external quality assessment(EQA)samples from the National Center for Clinical Laboratories.Compare the test results of different experimental groups,its main content includes the specificity,sensitivity,accuracy,and the average(X),stdev(S),coefficient of variation(CV)of the weak positive constant serum standard panel S/CO values within the batch.Usingχ^(2) test and Kappa test to evaluate the differences and consistency of the qualitative detection performance between the different experimental groups.Results:The results of 4 random experimental groups were as follows:the specificity(50/50),the sensitivity(35/35),the result consistency(85/85),and the correct rate(85/85)were 100%.The CV of HBsAg quality control test results were less than 7%,which met the acceptance standard within 15%.Byχ^(2) test,the detection consistency between the two sets of instruments in 4 experimental groups was excellent,and the difference was not statistically significant(P>0.05).Conclusion:The results of HBsAg detected by two sets of automatic ESILA systems were consistent.The blood screening laboratory of the blood station could compare and analyze the test results of routine unpaid blood donors samples,weak positive serum standard panel,and the EQA samples.Ways to compare the performance and differences between devices.

关 键 词：全自动酶免分析系统 HBSAG 仪器设备性能 

分 类 号：R446.1[医药卫生—诊断学]