目的　应用表面等离子体共振（surface plasmon resonance，SPR）技术快速检测肠道病毒71型（enterovirus 71，EV71）灭活疫苗抗原含量，并对该方法进行验证。方法　将兔抗EV71抗体偶联到SPR芯片表面，监测EV71抗原与抗体结合后SPR 芯片表面信号的变化。使用EV71国家抗原标准品建立SPR检测EV71抗原的新方法，验证该方法的线性、专属性、精密度和准确度。取6批次疫苗原液进行抗原检测，比较SPR与ELISA 2种检测方法的差异。结果　兔抗EV71抗体对EV71具有良好的亲和能力，偶联水平为8 037响应单位。EV71国家抗原标准品的抗原含量在12.5～200.0 U/mL时，与SPR仪响应值的变化量呈良好的线性关系，决定系数≥0.990 0。芯片与Sabin株脊髓灰质炎灭活疫苗、PBS均无交叉反应。重复性和中间精密度的相对标准偏差分别为1.52%和1.54%。准确度的回收率在91.70%～103.85%。SPR技术和ELISA检测不同批次疫苗原液抗原含量，虽差异有统计学意义（Z=﹣2.201， P=0.028），但2种方法检测的相对标准偏差＜15%，且结果趋势一致。结论　建立并验证了应用SPR技术检测EV71抗原含量的新方法，该法线性、专属性、精密度、准确度良好，可用于EV71灭活疫苗抗原含量的快速检测。

Objective　To establish and validate the surface plasmon resonance (SPR) method for the rapid detection of antigenic content of inactivated enterovirus 71 (EV71) vaccine. Methods　Rabbit anti-EV71 antibody was coupled to the surface of a SPR chip, and the SPR chip surface signals were monitored following the binding of EV71 antigen to the antibody. EV71 national antigen standard was used to establish the SPR method for EV71 antigen content detection. The linear range, specificity, precision and accuracy of this method were verified. Six batches of EV71 vaccine bulk were used for antigen detection, and the differences between the SPR and ELISA methods were compared. Results　Rabbit anti-EV71 antibody coupled at a level of 8 037 response unit, indicating a good affinity for EV71. When the antigen content of EV71 national antigen standards ranged over 12.5-200.0 U/mL, it showed a good linear relationship to the response value of SPR analyzer, with coefficient of determination≥0.990 0. There was no cross-reactivity of the chip with Sabin strain poliovirus inactivated vaccine and PBS. The relative standard deviations (RSDs) of repeatability and intermediate precision were 1.52% and 1.54%, respectively. The accuracy recoveries were in the range of 91.70%-103.85%. A statistically significant difference was found between the SPR and ELISA for detecting the antigenic content of different batches of vaccine bulk (Z=﹣2.201， P=0.028), but the RSD was less than 15%, and the results showed a consistent trend. Conclusions　Detection method of EV71 antigen content using the SPR technique is established and validated. The method has good linearity, specificity, precision and accuracy, thus can be used for rapid antigen content detection of EV71 inactivated vaccine.