摘要
目的对采用磁微粒化学发光法的迈克i3000全自动化学发光免疫分析仪检测血清生长分化因子15(GDF-15)水平进行性能确认,评价其是否符合临床实验室检测的相关要求。方法根据美国临床实验室标准化协会EP系列文件和中国合格评定国家认可委员会的相关要求,对i3000全自动化学发光免疫分析仪检测GDF-15的精密度、准确度、线性范围、临床可报告范围和特异性进行确认和评价。结果i3000全自动化学发光免疫分析仪检测GDF-15的高浓度样本的CV批内为2.29%,低浓度样本的CV批内为3.78%;高浓度样本的CV批间为2.88%,低浓度样本的CV批间为3.79%,显示出优异的批内、批间重复性;加标回收实验的平均回收率为101.26%,且每个加标样本的回收率均在95.0%~105.0%,平均回收率与各组间的回收率的差值<10%;线性范围为100~30000 pg/mL,临床可报告范围为100~300000 pg/mL。血红蛋白(≤19.8 g/L)、甘油三酯(≤36 mmol/L)、胆红素(≤13680μmol/L)时对GDF-15的检测无干扰,显示出良好的特异性。结论i3000全自动化学发光免疫分析仪检测GDF-15的精密度、准确度、线性范围、临床可报告范围和特异性确认符合相关规范要求,能为临床诊治相关疾病提供依据。
Objective This study was intended to validate the performance of Maccura i3000 automated chemiluminescence immunoassay system,which employs the magnetic particle chemiluminescence method for measuring serum levels of growth differentiation factor 15(GDF-15),and to assess its compliance with the necessary standards for clinical laboratory testing.Methods The validation and evaluation of the precision,accuracy,linear range,clinical reportable range,and specificity of Maccura i3000 automated chemiluminescence immunoassay sstem for GDF-15 detection was conducted in accordance with the EP Guidelines from the clinical laboratory standardization institute and the applicable criteria set forth by the China national accreditation service for conformity assessment.Results The CVwithin-batch for high-concentration samples was 2.29%,while for low-concentration samples,it was 3.78%.The CVwithin-batch for high-concentration samples was 2.88%,and for low-concentration samples,it was 3.79%,indicating excellent reproducibility both within and between runs.The average recovery rates from spiked recovery tests were 101.26%,with individual spiked sample recoveries ranging from 95.0%to 105.0%,and the variation between average recovery and group recoveries was less than 10%.The linear detection range was recorded as 100 to 30000 pg/mL,with a clinically reportable range set from 100 to 300,000 pg/mL.Additionally,substances such as hemoglobin(≤19.8 g/L),triglycerides(≤36 mmol/L),and bilirubin(≤13,680μmol/L)did not interfere with GDF-15 detection,which demonstrates a good specificity.Conclusion The i3000 automated chemiluminescence immunoassay system demonstrated satisfactory precision,accuracy,linear range,clinical reportable range,and specificity for GDF-15 detection,which not only fulfills the relevant specifications,but also provides a reliable reference for clinical diagnosis and management of associated diseases.
作者
古珍
王成洪
王媛媛
GU Zhen;WANG Chenghong;WANG Yuanyuan(Department of Laboratory,Hongya County Hospital of Traditional Chinese Medicine,Hongya,Sichuan 620360,China;Maccura Biotechnology Co.,Ltd.,Chengdu,Sichuan 610000,China)
出处
《检验医学与临床》
CAS
2024年第S02期48-52,共5页
Laboratory Medicine and Clinic
基金
2022年四川省眉山市指导性科技计划项目(kjzd202295)。
关键词
磁微粒化学发光测定法
生长分化因子15
性能确认
magnetic particle chemiluminescence assay
growth differentiation factor 15
performance validation
