国产癌胚抗原放射免疫分析药盒质量考察

Inspection of Homemade Immunoassay Kits for Carcinoembryonic Antigen

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 homemade RIA and IRMA kits for carcinoembryonic antigen (CEA) were examined and their data were analyzed using the national quality control sera (QC sera) for CEA immunoassay as reference materials. It has been observed that NSB/T%<%5, B0/T%>% 25and |r|>0. 9900 when fitting by log dose-logit B/B0 mode, effective dose values-ED25,ED50 and EU75 are in range of dose-response curves, respectively, the mean values of QC sera fall onto the limites and their biases do not exceed±10% in 8 RIA kits and ratio of Bmax/T to Bmin/T >20, average batch coefficient variation is less than 4% and r>0. 9900 when fitting by log dose -log B/Bmax mode, the mean values of QC sera fall onto the limites and their biases do not exceed ±15% in 4 IRMA kits.