罗氏E601电化学发光免疫分析仪剩余试剂的再利用评估  

Reuse evaluation of remaining reagents in Roche E601 electrochemiluminescence immunoassay analyzer

作　　者：杨佳莉 彭蓉蓉 刘文芳 YANG Jiali;PENG Rongrong;LIU Wenfang(Clinical Laboratory,Changzhou De'an Hospital,Jiangsu Province,Changzhou,Jiangsu 213000,China;不详)

机构地区：[1]江苏省常州市德安医院检验科,江苏常州213000 [2]宜兴市中医院

出　　处：《中国国境卫生检疫杂志》2024年第6期619-621,共3页Chinese Journal of Frontier Health and Quarantine

基　　金：江苏省自然科学基金项目(BK20201084)。

摘　　要：目的分析罗氏E601电化学发光免疫分析仪检测梅毒螺旋体(TP)抗体、人类免疫缺陷病毒(HIV)抗体和抗原(P24)、丙肝病毒(HCV)抗体使用混合试剂再利用的可行性,为降低检测成本提供参考。方法用混合剩余试剂检测血清中TP、HIV、HCV的临界值(COI值),分析精密度、准确度;同时用原装试剂与混合试剂分别检测同一标本,比较其均值并作相关性分析。结果混合后的TP试剂的批内精密度分别为1.80%、3.35%,批间精密度分别为8.20%、3.60%;混合后的HIV试剂批内精密度分别为3.70%、2.17%;批间精密度分别为9.60%、3.14%;混合后的HCV试剂批内精密度分别为0.00%、5.60%;批间精密度分别为0.00%、6.50%。TP、HIV、HCV混合试剂准确度检测结果与室间质评回报结果一致;3个项目的阳性符合率、阴性符合率均为100%。3个项目的相关系数依次为0.9996、0.9986、0.9984,r≥0.975,提示两种试剂相关性良好。结论罗氏E601电化学发光仪使用的HCV、HIV、TP的剩余试剂,相同批号的试剂可混合使用。Objective To analyze the feasibility by using mixed reagent for the detection of Treponema pallidum antibody(TP),human immunodeficiency virus(HIV)antibody and antigen(P24),hepatitis C virus antibody(HCV)on Roche E601 electrochemiluminescence immunoassay analyzer,to provide reference for reducing the detection cost.Methods The critical values(COI value)of TP,HIV and HCV were detected by mixing residual reagents,the precision and accuracy were analyzed.The same serum samples were detect by using original and mixed reagents,the mean values were compared and the correlation analysis was conducted.Results The intra batch precision of mixed TP reagent was 1.80%and 3.35%,the inter batch precision was 8.20%and 3.60%,respectively.The intra batch precision of the mixed HIV reagent was 3.70%and 2.17%,the inter batch precision was 9.60%and 3.14%,respectively.The intra batch precision of mixed HCV reagents were 0.00%and 5.60%,the inter batch precision was0.00%and 6.50%,respectively.The accuracy test of TP,HIV,HCV mixed reagents were all consistent with the inter laboratory quality evaluation report.The positive and negative conformity rate of the three items were all 100%.The three items correlation coefficient was 0.9996,0.9986,0.9984,r≥0.975,indicated a good correlation between the two reagents.Conclusion The remaining reagents of HCV,HIVand TP used in Roche E601 electrochemiluminescence analyzer could be mixed with reagents of the same batch.

关 键 词：电化学发光装置 试剂 再利用 

分 类 号：R183[医药卫生—流行病学] R373[医药卫生—公共卫生与预防医学]