食品科学

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3 种β-兴奋剂化学发光酶免疫试剂盒分析检测方法的评价

宁 霄,张伟清,梁瑞强,曹 进 ,张庆生   

  1. 中国食品药品检定研究院,北京 100050
  • 出版日期:2016-06-25 发布日期:2016-06-29
  • 通讯作者: 曹进 E-mail:caojin@tsinghua.org.cn

Evaluation of Three β-Adrenergic Agonist Chemiluminescence Enzyme Immunoassay Detection Kits

NING Xiao, ZHANG Weiqing, LIANG Ruiqiang, CAO Jin, ZHANG Qingsheng   

  1. National Institutes for Food and Drug Control, Beijing 100050, China
  • Online:2016-06-25 Published:2016-06-29
  • Contact: CAO Jin, E-mail:caojin@tsinghua.org.cn

摘要:

选取3 种市售β-兴奋剂化学发光酶免疫分析检测试剂盒,从线性关系、灵敏度、选择性、检出限、准确度、重复性及变异性等方面进行实验,并经农业部1025号公告—18—2008中高效液相色谱-串联质谱法验证比较,初步建立了一套化学发光酶免疫分析检测试剂盒质量评价方法。结果表明:沙丁胺醇、盐酸克伦特罗、莱克多巴胺3 种试剂盒在测定范围内线性关系良好,灵敏度分别为0.7、1.8、1.0 ng/mL,检出限分别为0.2、0.1、0.2 ng/mL,猪肝、猪肉和牛肉的回收率在81.9%~115.2%之间,重复性变异系数为3.3%~9.7%,批间变异系数为9.9%~16.5%,交叉反应率均符合产品说明书要求,可以用于猪肝、猪肉、牛肉样品中沙丁胺醇、盐酸克伦特罗、莱克多巴胺的残留检测。

关键词: 沙丁胺醇, 盐酸克伦特罗, 莱克多巴胺, 化学发光酶免疫分析, 试剂盒, 评价方法

Abstract:

In this study, three commercially available β-adrenergic agonist chemiluminescence enzyme immunoassay(CLEIA) detection kits were evaluated in term of regression curve, sensitivity, specificity, detection limit, accuracy,reproducibility and inter-assay coefficients of variation. The validated test between CLEIA and high performance liquidchromatography-tandem mass spectrometry (HPLC-MS/MS) was done. This work established a methodology for thequality evaluation of CLEIA test kits. The results showed that three detection kits all had good linearity. Their sensitivitiesfor three β-adrenergic agonists, salbutamol, clenbuterol hydrochloride and ractompaine, were 0.7, 1.8, and 1.0 ng/mL, andthe corresponding limits of detection (LODs) were 0.2, 0.1, and 0.2 ng/mL, respectively. The recovery rates from spikedpork liver, pork and beef were between 81.9% and 115.2%. The reproducibility and inter-assay coefficients of variationwere 3.3%–9.7% and 9.9%–16.5%, respectively. Cross-reactivity rate was in compliance with the product specificationrequirements. The three kits can be used in detection of salbutamol, clenbuterol hydrochloride and ractompaine residues inpork liver, pork and beef.

Key words: salbutamol, clenbuterol hydrochloride, ractompaine, chemiluminescence enzyme immunoassay (CLEIA), kit, evaluation method

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