电化学发光检测乙肝血清学标志物相关试剂的性能验证  

Performance Verification of Electrochemiluminescence Detection Reagents Related to Hepatitis B Serological Markers

作　　者：史云峰 杜卉莲 SHI Yun-feng;DU Hui-lian(Panjin Liaoyou Baoshihua Hospital,Liaoning Panjin 124010)

机构地区：[1]盘锦辽油宝石花医院,辽宁盘锦124010

出　　处：《中国医疗器械信息》2022年第21期54-56,共3页China Medical Device Information

摘　　要：目的:观察电化学发光法检测乙肝血清学标志物相关试剂性能的全过程,验证该方法的准确度。方法:选择美国贝特曼库尔特公司生产的UniCel DxI800全自动免疫分析仪,基于CLSI的EP15-A的标准,对精密度结果、准确程度、线性范围等进行检测。结果:①乙肝五项检测批内CV测定结果均在厂家提供数值之下,总CV测定结果均在厂家提供数值之下;②基于UniCel DxI800全自动电化学发光免疫分析仪检测乙肝五项,三次实验室间质检测结果显示,PT均达到100%,准确程度满足要求;③基于检测结果的回归曲线显示,r2=0.9958,处于“上下波动临界值0.03”的范围之内,超过0.95,符合标准要求。结论:通过电化学发光法检测乙肝血清学标志物相关试剂的性能,检测结果十分理想。Objective:To observe the whole process of the electrochemiluminescence method for detecting the performance of the reagents related to hepatitis B serological markers and verify the accuracy of the method.Methods:The UniCel DxI800 automatic immunoassay analyzer produced by Bateman Coulter,USA,based on CLSI’s EP15-A standard,was selected to test the precision results,accuracy,and linear range.Results:①The CV measurement results of the five hepatitis B test batches were below the values provided by the manufacturer,and the total CV measurement results were all below the values provided by the manufacturer;②The five hepatitis B tests were detected by the UniCel DxI800 automatic electrochemiluminescence immunoassay analyzer,the results of three laboratory interstitial tests showed that PT reached 100%,and the accuracy met the requirements;③The regression curve based on the test results showed that r2=0.9958,which was within the range of"up and down fluctuation critical value 0.03",exceeding 0.95,meeting the standard Claim.Conclusion:The performance of reagents related to hepatitis B serological markers detected by electrochemiluminescence method is very satisfactory.

关 键 词：电化学发光检测 乙型肝炎 血清学标志物 性能验证 

分 类 号：R446.1[医药卫生—诊断学]