摘要
目的利用酶联免疫吸附试验,建立了非典型肺炎(SevereAcuteRespiratorySyndrome,SARS)冠状病毒抗体滴度的检测方法。方法与结果经验证,该方法检测249份阴性样本,1份假阳性;47份阳性样本,均检出阳性,方法的特异性达到99.7%;在0.5～8U/ml效价范围内线性良好,相关系数>0.98;回收率在85%-110%之间,重复性良好,cv<2%(α=0.05,n=5);中间精密度cv<18%(α=0.05,n=5)。结论该方法能达到免疫学定量测定方法的要求,可用于血浆及静脉注射用人SARS免疫球蛋白制品的SARSIgG抗体效价检测和质量控制。
Objective To develop a determination method for Sever Acute Respiratory drome （SARS） Coronavirus antibody titer based on the ELISA method. Methods ＆ Results Testing 249 negative and 47 positive samples, all positive samples and one of 249 negative sam- ples showed positive results. Thus the specificity is more than 99.7%. The calibration curve is linear over the titer range from 0.SU/ml to 8.0U/ml with r〉0.98. Recovery ranges from 85% to 110%. And accuracy of within-clay is less than 2%（a=0.05, n=5）. While accuracy of inter-person is less than 18%（α=0.05 ,n=5）. Conclusion The method complies with the requirement for immunoas- says and can be adapt to determine the SARS antibody titer in human plasma or human SARS Immunoglobulin products.
出处
《药品评价》
CAS
2005年第5期358-361,共4页
Drug Evaluation
基金
国家863计划课题
项目编号:2003AA208202
