• 中国科学论文统计源期刊
  • 中国科技核心期刊
  • 美国化学文摘(CA)来源期刊
  • 日本科学技术振兴机构数据库(JST)

临床输血与检验 ›› 2016, Vol. 18 ›› Issue (2): 152-157.DOI: 10.3969/j.issn.1671-2587.2016.02.020

• 实验技术与方法 • 上一篇    下一篇

快速乳胶散射免疫比浊法检测尿RBP的方法学评价*

刘灵燕,耿朝晖,钟政荣   

  1. 201999 上海交通大学医学院附属第九人民医院
  • 收稿日期:2016-02-02 出版日期:2016-04-20 发布日期:2016-09-21
  • 通讯作者: 钟政荣,(Tel)021-56691101-6348。
  • 作者简介:刘灵燕(1987-),女,江西吉安人,技师,硕士,主要从事临床血液体液学检验工作,(E-mail)sunshinesmilelly@sina.com。
  • 基金资助:
    *本课题受上海市科委基金(No.11DZ1921803)和院优青基金(No.13YYQO2)资助

Evaluation for Examination Methodology of Urinary Retinol Binding Protein by Latex Immunonephelometry

LIU Ling-yan, GENG Zhao-hui, ZHONG Zheng-rong   

  1. No.9 People Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 201999
  • Received:2016-02-02 Online:2016-04-20 Published:2016-09-21

摘要: 目的对快速乳胶散射免疫比浊法检测尿视黄醇结合蛋白(retinol binding protein, RBP)进行方法学评价。方法根据美国临床实验室标准化委员会(CLSI)中相关文件规定,对本研究方法进行精密度、线性范围、准确度、灵敏度和特异度评价。结果通过本方法检测尿RBP,最低检测限为0.037 8mg/L;重复性精密度为1.121%,中间精密度为5.536%,再现性精密度为6.657%;线性范围在0~10 mg/L内;回收率分别为98.67%和105.00%;当Tbil<100 mg/L时,Hb<10 mg/L时,尿Tbil和Hb对RBP的检测不存在干扰;与自动生化分析仪上采用尿RBP比对试剂盒检测结果进行相关性分析,r2=0.9740,相关度较好,且两种方法对40份临床标本检测的阳性率的差异无统计学意义(χ2=0.952,P=0.329)。结论本研究通过快速乳胶散射免疫比浊法检测尿RBP,具有高灵敏度、高精密度、高准确度、抗干扰强等优点,适合在临床诊断中对尿RBP进行即时检测(point-of-care testing, POCT)。

Abstract: ObjectiveTo evaluate the detection methodology of urinary retinol binding protein(RBP) by latex immune-nephelometry. MethodsTyhe Precision, linear range, accuracy, sensitivity, and specificity of the examination methodology that is currently used were evaluated according to the standard protocol of National Committee for Clinical Laboratory Standards (CLSI) documents. ResultsThe lowest detection limit in this methodology was 0.037 8 mg/L and the linear range was 0~10 mg/L. Repeatability precision was 1.121%, inter-assay precision was 5.536% and reproducibility precision was 6.657%. The average recovery rate was 101.83% and there was no interference to RBP detection under the existence of <100 mg/L total bilirubin or <10 mg/L hemoglobin. There was a positive correlation between the present methodology and the control reagent of urinary RBP detection (r2 =0.974 0), which was based on the platform of automatic biochemical analyzer, and there was no significance comparing with the results of urinary RBP of 40 clinical samples using these two methodology. ConclusionThe present method of urinary RBP detection, with high sensitivity, precision, accuracy and strong anti-interference, is suitable for clinical laboratory point-of-care testing (POCT).

中图分类号: