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

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

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。

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.