HISCL5000全自动高敏免疫分析仪传染病项目性能验证分析  

The Performance Verification of Infectious Disease Project Using HISCL5000 Automatic High Sensitivity Immune Analyzer

作　　者：王凡强 曲婧 李世浩 吴红丽 张辉 WANG Fanqiang;QU Jing;LI Shihao;WU Hongli;ZHANG Hui(Department of Laboratory Medicine, Maternity and Child Care Center of Qinhuangdao, Qinhuangdao 066000, China)

机构地区：[1]秦皇岛市妇幼保健院检验科,河北秦皇岛066000

出　　处：《标记免疫分析与临床》2021年第3期524-528,536,共6页Labeled Immunoassays and Clinical Medicine

基　　金：秦皇岛市科学技术研究与发展计划(编号:201805A056)。

摘　　要：目的根据ISO15189认可的要求和临床的实际需求,对HISCL-5000全自动高敏免疫分析仪进行性能验证,从而保证临床样本检验的准确性。方法对HISCL-5000高敏免疫分析仪分别进行本底计数、批内精密度、批间精密度、线性验证、符合率(比对)、准确性、检出限的验证。结果HISCL-5000高敏免疫分析仪检测传染病HBsAg、HBsAb、HBeAg、HCV-Ab、TP-Ab和HIVAg+Ab低浓度批内精密度CV分别为1.84%、3.82%、2.00%、1.96%、8.10%、1.45%;高浓度批内精密度CV分别为4.15%、1.60%、1.74%、1.52%、3.67%、1.57%,HBeAb低浓度批内精密度CV为5.23%,HBeAb高浓度批内精密度CV为2.83%。低浓度和高浓度样本批间精密度CV分别为HBsAg 1.96%、2.06%,HBsAb 3.64%、4.53%,HBeAg 3.29%、2.62%,HCV-Ab 2.30%、2.40%,TP-Ab 5.70%、8.17%,HIVAg+Ab 4.53%、2.53%,高浓度HBeAb 6.73%,低浓度HBeAb 1.40%。HBsAg和HBsAb线性验证R2值均>0.95,符合验证要求。两台仪器HBsAg和HBsAb定量检测结果符合率Kappa≥0.75,表示两台仪器的结果高度一致。HBsAg定量检测准确度偏差<10%,符合率大于90%以上,传染八项检出限验证结果全部合格,仪器符合性能验证要求。结论HISCL-5000全自动高敏免疫分析仪检测传染八项结果准确性较高,可靠性较好,检验速率高效,随时满足临床需求,临床应用价值较高。Objective To verify the performance of HISCL-5000 Automatic High Sensitivity Immunoassay Analyzer according to the requirements of ISO15189 and clinical practice standards,so as to ensure the accuracy of clinical sample tests.Methods The background count,intra-batch precision,inter-batch precision,linear verification,coincidence rate(comparison),quasi determination and detection limit of HISCL-5000 High Sensitivity Immunoassay Analyzer were all verified in the current study.Results HBsAg,HBsAb,HBeAg,HCV-Ab,TP-Ab and HIVAg+Ab were detected by using HISCL5000 High Sensitivity Immunoassay Analyzer.The intra-batch precision CV of low concentration were 1.84%,3.82%,2.00%,1.96%,8.10%and 1.45%,respectively.The intra-batch precision CV of high concentration were 4.15%,1.60%,1.74%,1.52%,3.67%,and 1.57%,respectively.The intra-batch precision CV of low concentration of HBeAb was 5.23%,and the intra-batch precision CV of high concentration of HBeAb was 2.83%.The inter-batch precision CV of low and high concentration samples were 1.96%and 2.06%for HBsAg,3.64%and 4.53%for HBsAb,3.29%and 2.62%for HBeAg,2.30%and 2.40%for HCV-Ab,5.70%and 8.17%for TP-Ab,4.53%and 2.53%for HIVAg+Ab,respectively,and was 6.73%for high concentration HBeAb and 1.40%for low concentration HBeAb.The linear verification R2 value of HBsAg and HBsAb was>0.95,which met the verification requirements.The coincidence rate of HBsAg and HBsAb quantitative detection results of the two instruments kappa was≥0.75,indicating that the results of the two instruments were highly consistent.The accuracy deviation of HBsAg quantitative detection was<10%,and the coincidence rate was more than 90%.The verification results of the eight detection limits of infection were all qualified,and the instrument met the performance verification requirements.Conclusion HISCL-5000 Automatic High Sensitivity Immunoassay Analyzer has a high accuracy in detecting eight infectious items with a good reliability,high test speed,and can meet the clinical needs at any time points and has a high

关 键 词：HISCL5000高敏免疫分析仪 本底计数 批内精密度 批间精密度 线性验证 符合率 准确定 检出限 

分 类 号：R-331[医药卫生]