摘要
目的对广州市达瑞生物技术股份有限公司与贝克曼库尔特商贸(中国)有限公司的激素6项化学发光试剂盒进行性能比较,为国产的商品化激素类化学发光法定量测定试剂盒替换进口激素类化学发光法定量测定试剂盒提供依据。方法用国产的和进口的激素6项化学发光试剂盒分别检测最低检测限、精密度、准确度及进行样本比对试验,对样本的检测结果进行相关性和一致性分析。结果国产的促卵泡激素(follicle stimulating hormone,FSH)、促黄体生成素(luteinizing hormone,LH)、雌二醇(estradiol,E2)、孕酮(progesterone,PROG)、催乳素(prolactin,PRL)、睾酮(testosterone,TES)试剂最低检测限均低于或等于进口的相应试剂的最低检测限;国产的激素6项试剂盒的精密度都<8%,进口的激素6项试剂盒精密度都<12%;各项目的线性相关系数r均大于或等于0.9,相关性很好。结论国产的激素6项试剂盒与进口的激素6项试剂盒均具有良好相关性及较高的一致性,可替代国外昂贵试剂应用于临床检测和基础医学的研究。
Objective To compare the performance of the six hormone CLIA kit from Guangzhou Darui Biotechnology Co., Ltd. and Beckman Coulter Commercial Enterprise（China） Co., Ltd, and provide the basis for the domestic commercial hormone chemiluminescence determination reagent kit replacement of the import one. Methods The minimum detection limit, precision, accuracy and sample comparison test were detected with domestic and imported hormone CLIA kit, respectively. The correlation and consistency of the test results were analyzed. Results The sensitivity of follicle stimulating hormone（FSH）, luteinizing hormone（LH）, estradiol（E2）, progesterone（PROG）, prolactin（PRL）, and testosterone（TES） reagents of homemade were lower than or equal to the reagents of imported. The precision of the six hormone CLIA kit for the homemade was 〈 8%, compared to the precision of the six hormone CLIA kit for imported 〈12%. The linear correlation coefficient r value of each objective were ≥0.9. Conclusion The six hormone CLIA kit for homemade has a good correlation and high consistency with the imported kit, can be used to replace the foreign expensive reagents for clinical detection and basic medical research.
出处
《分子诊断与治疗杂志》
2017年第6期408-415,共8页
Journal of Molecular Diagnostics and Therapy
基金
广州市科技计划项目(201504291007307)
关键词
化学发光免疫分析
促卵泡激素
促黄体生成素
雌二醇
孕酮
催乳素
睾酮
Chemiluminescent immunoassay
Follicle stimulating hormone
Luteinizing hormone
Estradiol
Progesterone
Prolactin
Testosterone
