安图A2000全自动化学发光分析仪检测IGFBP3的性能验证及与IGF-1相关性研究  

The performance of Auto A2000 automatic chemiluminescence analyzer in detection of IGFBP3 and its correlation with IGF-1

作　　者：陈庆[1] 刘英杰[1] 郑桂喜[1] CHEN Qing;LIU Ying-jie;ZHENG Gui-xi(Department of clinical Laboratory,Qilu Hospital of Shandong University,Shandong Jinan 250012)

机构地区：[1]山东大学齐鲁医院检验科,山东济南250012

出　　处：《医学检验与临床》2024年第3期1-4,共4页Medical Laboratory Science and Clinics

基　　金：国家自然科学基金面上项目,项目编号:82172347。

摘　　要：目的:对安图A2000全自动化学发光仪检测血清胰岛素样生长因子结合蛋白3(IGFBP3)的性能进行评价,并探讨其在矮小症、性早熟及垂体性病变中与IGF-1的相关性。方法:对安图A2000系统检测IGFBP3的精密度(CV)、线性范围、可报告范围、参考区间进行验证。选取2023年1月-2023年9月在本院诊断或治疗的矮小症21例、性早熟10例、垂体性病变19例,回顾性分析其胰岛素生长因子-Ⅰ(IGF-1)和IGHBP3水平,并进行Spearman相关性分析。结果:IGFBP3高低水平质控品批内CV为2.019%、2.931%,批间CV为3.818%、4.137%;测定结果在0.3~16.0μg/mL范围内呈线性,线性回归方程为Y=0.9995X~0.0213,R2=0.9974;临床可报告范围为0.3~32.0μg/mL;18~70岁和>70岁健康体检者检测结果均在厂家提供的参考区间内;IGFBP3和IGF-1在矮小症、性早熟和垂体性病变患者中具有较好的相关性(r=0.81,P<0.0001)。结论:安图A2000检测血清IGFBP3的性能能够满足实验室质量要求,且与IGF-1具有较好的相关性。Objective:To evaluate the performance of serum insulin-like growth factor binding protein 3(IGFBP3)detected by Auto A2000 automatic chemiluminescence instrument,and to explore the correlation between IGFBP3 and IGF-1 in patients with short stature,precocious puberty and pituitary lesions.Methods:The precision(CV),linear range,clinical reportable range and reference interval of IGFBP3 detected by Auto A2000 system were verified.A total of 21 cases of short stature,10 cases of precocity and 19 cases of pituitary lesions diagnosed or treated in our hospital from January 2023 to September 2023 were selected.The levels of insulin growth factor-Ⅰ(IGF-1)and IGHBP3 were retrospectively analyzed,and the Spearman correlation analysis was performed.Results:The within-run CV of high and low levels quality control of IGFBP3 were 2.019%and 2.931%,respectively.And the between-run CV were 3.818%and 4.137%,respectively.The linear regression equation was Y=0.9995X-0.0213,R 2=0.9974 within the range of 0.3-16.0μg/mL.The clinical reportable range was 0.3~32.0μg/mL.The results of IGFBP3 were all within the reference interval provided by the manufacturer.There was a good correlation between IGFBP3 and IGF-1in patients with short stature,precocious puberty and pituitary lesions(r=0.81,P<0.0001).Conclusion:The performance of Auto A2000 in detection of serum IGFBP3 could meet the quality requirements of the laboratory.Meanwhile,our results demonstrated a good correlation between IGFBP3 and IGF-1.

关 键 词：全自动化学发光分析仪 胰岛素样生长因子结合蛋白3 胰岛素样生长因子-1 性能验证 

分 类 号：R446[医药卫生—诊断学]