肠道病毒71型抗原检测试剂参考品制备及标定

Preparation and Calibration of Quality Control Reference for Enterovirus 71 Antigen Detection Reagent

目的制备一套EV71抗原检测试剂盒质量控制用参考品。方法用组织培养法制备的一组肠道病毒原液及EV71病毒液,制备成10份阴性参考品、10份阳性参考品、2份灵敏度参考品及1份精密度参考品;以上样品经多人次标定后确定最终结果。结果阴、阳性参考品各10份标定结果分别为10阴及10阳;2份灵敏度参考品标定结果分别为177.97U/mL和1966.86U/mL;精密度参考品平均CV值9.29%。参考品37℃保存5天及反复冻融6次对检测结果没有影响。结论制备的参考品经标定,并通过反复冻融、37℃热稳定性试验,检测结果稳定,可用于EV71抗原检测试剂的质量控制,保证抗原检测试剂检测结果的特异性、灵敏度及稳定性。

Objective To prepare an batch of enterovirus 71（EV71） antigen reference for quality control of EV71 antigen detection kit.Methods The EV71 antigen and several kinds of association enterovirus were prepared by using tissue culture technology.The standard references of EV71 antigen consisted of 10 negative samples,10 positive samples,2 sensitivity samples and 1 precision sample were established and calibrated.Results The calibration results of each ten positive and negative reference samples were consistent with the predicted results.The calibration results for 2 sensitivity reference material were177.97U/mL and 1966.86U/mL and the average CV% value for one precision sample calibration was 9.29%.The process of five times freeze-thawing for reference samples at 37℃ for 6 days did not affect the stability of the references.Conclusion The prepared reference of EV71 antigen could be used for quality control to ensure the specificity and stability of EV71 antigen detection reagents.