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用癌胚抗原国家质量控制血清作为标准物对12个国产CEARIA(癌胚抗原放射免疫分析)与IRMA(免疫放射分析)药盒进行了质量检验和分析。其中,8个CEARIA药盒的NSB/T%(非特异性结合百分率)<%5,B0/T>25,|r|>0.9900,有效剂量值ED25、ED50和ED75均在剂量-反应曲线范围内,低、中、高质控血清测定均值都在各自的参考范围内,且偏倚均不超过±10%;4个CEAIRMA药盒的Bmax/Bmin比值均大于20,平均批变异系数小于4%,r>09900,低、中、高质控血清测定均值都在各自的参考范围内,且偏倚均不超过±15%。
Twelve home-made CEARIA (carcinoembryonic antigen radioimmunoassay) and IRMA (immunoassay) kits were quality tested and analyzed using CEA serum as a standard. Among them, 8 CEARIA kits had NSB/T% (non-specific binding percentage) <%5, B0/T>25, |r|>0.9900, and effective dose values ED25, ED50, and ED75 were all in the dose-response curve. In the range, the mean value of the low, medium, and high quality control serums were within their respective reference ranges, and the biases did not exceed ±10%; the Bmax/Bmin ratios of the 4 CEAIRMA kits were all greater than 20, and the average batch coefficient of variation was less than 4 %, r>09900, mean values of low, medium, and high quality control serums were within their respective reference ranges, and the biases did not exceed ±15%.