雅培i2000全自动化学发光免疫分析仪性能评价方法研究

Study on the performance evaluation of ARCHITECT i2000 automatic chemiluminescence immunoassay analyzer

目的对雅培i2000全自动化学发光免疫分析仪的性能进行了评价。方法参考《YY/T1155-2009全自动发光免疫分析仪》医药行业标准和国家质量监督检验检疫总局颁布的有关医疗器械检定校准计量技术规范,阐述了准确度、重复性、线性范围、交叉污染等指标的评价方法和选取理由。结果准确度:197pmol/L胰岛素标准品测定结果误差为6pmol/L,20pmol/L胰岛素标准品测定结果误差为2pmol/L;重复性:对20pmol/L的胰岛素标准品重复测定6次,6次测定的相对标准偏差为2%;稳定性:开机4h后和8h后的相对偏差分别为3%和4%;线性范围:20～197pmol/L的胰岛素范围内,其线性相关系数可达到0.997;交叉污染:从低到高交叉污染率为1%,从高到低交叉污染率为0.2%。结论提出的方法可用于日常全自动免疫分析仪性能的评价和校准,有助于检测结果的准确和可比。

Objective To evaluate the performance of ARCHITECT i2000 automatic chemiluminescence immunoassay analyzer. Methods With refer to the YY/T 1155-2009 automatic chemiluminescence immunoassay analyzer and related regulations published by the State Administration of Quality Supervision, Inspection and Quarantine, the protocols for accuracy, reproducibility, linear range, cross-contamination and so on were described in detail. Results Accuracy： the bias was 6pmol/L for 197pmol/L insulin sample and 2 pmol/L for 20 pmol/Linsulin sanple. Reproducibility： the standard deviation was 2% for 6 times analyses of 20 pmol/Linsulin sample. Stability： the relative bias was 3% and 4%, respectively, after 4 and 8 hours from power on. Linear range： the linear coefficient factor was 0.997 from 20 to 197pmol/L of insulin, cross-contamination： 1% from low level to high level and 0.2% from high level to low level. Conclusion The proposed protocols can he Used for routine performance evaluation of automatic chemiluminescence immunoassay analyzer and can benefit the accuracy and comparability of clinical diagnostic results.