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