基于空间临近化学发光技术开发的胰岛素测定试剂盒性能评价

Evaluation of a quantitative determination kit for insulin with spatial proximity chemiluminescent technology

目的评价一种基于空间临近化学发光技术开发的胰岛素定量测定试剂盒。方法根据《体外诊断试剂分析性能评估系列指导原则》对该测定试剂盒的性能进行评价。评价性能包括线性范围、最低检测限、准确度、精密度、特异性、抗干扰能力,并与商品化的胰岛素测定试剂盒进行了临床比对分析。结果该试剂盒的检测范围为3~238 m IU/L,分析灵敏度为0.66 mIU/L;测定胰岛素国家标准品,偏差在±10%范围内,添加回收率在92.66%~102.22%。该测定试剂盒日内精密度变异系数(CV)不超过5%,日间精密度CV不超过5%,批间精密度CV不超过10%。当胰岛素原浓度低于100 ng/mL,C肽低于200 ng/mL时,无交叉反应;当样本中胆红素浓度低于200 mg/L,血红蛋白浓度低于2 g/L,抗坏血酸浓度低于40 mg/L,尿酸浓度低于200 mg/L时,均未出现明显干扰(相对偏差小于±10%)。与市售胰岛素测定试剂盒同时检测102例血清样本,证明两种试剂相关性较好。结论该试剂各项性能指标均符合体外诊断试剂要求,有望用于临床检测。

Objective This work aimed to evaluate an insulin quantitative assay kit based on spatial proximity chemiluminescent technology.Methods The developed assay kit was further evaluated by the methods refer to Guidelines for the Evaluation of Analytical Performance of In Vitro Diagnostic Reagents.The properties of the developed assay kit including linear range,minimum detection limit,accuracy,precision,specificity,anti-interference ability,were compared to the commercial insulin assay kits.Results The results indicate that(1)the detection range of the kit was 3-238 mIU/L,with the analytical sensitivity lower than 0.66 mIU/L;(2)further analysis on the national standard of insulin with the developed assay kit suggested that the deviation was within±10%,and the recovery rate was 92.66%-102.22%;(3)both intra-day and inter-day precision CV of the assay kit were less than 5%,while the inter-assay precision CV was less than10%;(4)no cross-reaction was observed,when the concentrations of proinsulin and the C-peptide were less than 100 and 200 ng/mL,respectively;(5)no obvious interference was observed,when the concentrations of bilirubin,hemoglobin,ascorbic acid,and uric acid were lower than 200 mg/L,2 g/L,40 mg/L,and 200 mg/L,respectively;(6)there was a good correlation between the developed assay kit and commercial insulin assay kit through analyzing 102 serum samples.Conclusion All the performance of the reagent could meet the requirements of in vitro diagnostic reagent,and be used in clinical testing.