胶乳免疫比浊法C反应蛋白测定试剂盒的准确度性能验证  

Accuracy Performance Verification of C-Reactive Protein Determination Kits by Latex Immunoturbidimetry

作　　者：黄燕虹[1] 张旭[1] 潘晓芳[1] 朱秀霞 Huang Yanhong;Zhang Xu;Pan Xiaofang;Zhu Xiuxia(Comprehensive Testing Lab 4 of Guangdong Medical Devices Quality Surveillance and Test Institute,Guangzhou Guangdong 510663,China)

机构地区：[1]广东省医疗器械质量监督检验所综合检验四室,广东广州510663

出　　处：《医疗装备》2021年第15期51-53,共3页Medical Equipment

基　　金：2019新型冠状病毒快速核酸检测试剂及新冠流感分型试剂盒的研发(No.202008070001)。

摘　　要：目的通过准确度性能验证结果,分析14家企业C反应蛋白(CRP)测定试剂盒的准确度性能是否符合YY/T 1513-2017《C反应蛋白测定试剂盒》行业标准要求。方法采用Beckman AU680全自动生化分析仪和14家企业试剂盒分别对由ERM■-DA474/IFCC国际标准物质获得的低(10.3 mg/L)、中(20.6 mg/L)、高(41.2 mg/L)3个浓度的样本进行检测,每个浓度均检测3次,并计算每个检测结果与标示值之间的相对偏差(RD)。结果14家企业试剂盒对高浓度样本检测结果的RD均符合行业标准YY/T 1513-2017的要求,即在-15%~15%之间;11家企业试剂盒对中浓度样本检测结果的RD符合行业标准要求,3家企业不符合行业标准要求;只有8家企业试剂盒对低浓度样本检测结果的RD符合行业标准要求,而6家企业不符合行业标准要求。结论采用ERM■-DA474/IFCC国际标准物质验证的14家企业CRP测定试剂盒的准确度性能结果差异较大,部分企业的准确度性能不符合行业标准要求。Objective Through the accuracy performance verification results,the accuracy performance of C-reactive protein(CRP)determination kits from 14 enterprises were analyzed to see whether the accuracy performance met the requirements of YY/T 1513-2017 C-Reactive Protein Testing Kit industry standard.Methods Beckman AU680 automatic biochemical analyzer and kits from 14 enterprises were used to detect the low(10.3 mg/L),medium(20.6 mg/L)and high(41.2 mg/L)samples obtained from ERM■-DA474/IFCC international standard substance.Each concentration was detected for three times,and the relative deviation(RD)between each detection result and the labeled value was calculated.Results The RD of the kits from 14 enterprises on high concentration samples all met the requirements of the industry standard YY/T 1513-2017,that is,between-15%and 15%;The RD of the kits from 11 enterprises on the medium concentration samples met the requirements of the industry standard,and 3 enterprises did not meet the requirements of the industry standard;The RD of the kits from only 8 enterprises on low concentration samples met the requirements of the industry standard,while 6 enterprises did not meet the industry standard requirements.Conclusion The results of accuracy performance of CRP determination kits from 14 enterprises verified by ERM■-DA474/IFCC international standard substance were quite different,and the accuracy performance of some enterprises even didn't meet the requirements of industry standard.

关 键 词：C反应蛋白测定试剂盒 C反应蛋白 准确度 

分 类 号：R446[医药卫生—诊断学]