Hebles-Duvison M, Cruz-Ruiz M, Vazquez-Rubio R, Macarro-Sancho I, Silva-Mejías C, Recio-Quijano F
Servicio Análisis Clínicos, Laboratorio de Bioquímica, H. U. de Valme, Sevilla, Spain.
Eur J Clin Chem Clin Biochem. 1995 Nov;33(11):881-5.
We evaluated the technical performance of two new commercial automated immunoassay systems of third-generation assays for thyrotropin. The interassay CV was 2.8% for AutoDELFIA and 3.25% for Access at thyrotropin concentrations of approximately 1.3 mIU/l. The lower detection limits of the assays were 0.023 mIU/l for AutoDELFIA and 0.0096 mIU/l for Access, and the functional sensitivity for a CV of 20% was 0.027 mIU/l and 0.028 mIU/l, respectively. Sample to sample carry over was negligible (0.0016% for AutoDELFIA and 0.005% for Access). The range of linearity was acceptable for Access (102-115%) but not for low thyrotropin concentrations in AutoDELFIA (143% for a thyrotropin value of 0.48 mIU/l). Correlation between AutoDELFIA and Access was adequate (r = 0.999). We conclude that both automated immunoassays offer good reliability, practicability and performance characteristics.
我们评估了两种用于促甲状腺激素的新型商用第三代自动化免疫分析系统的技术性能。在促甲状腺激素浓度约为1.3 mIU/l时，AutoDELFIA的批间变异系数为2.8%，Access为3.25%。AutoDELFIA检测限为0.023 mIU/l，Access为0.0096 mIU/l，变异系数为20%时的功能灵敏度分别为0.027 mIU/l和0.028 mIU/l。样本间携带污染可忽略不计（AutoDELFIA为0.0016%，Access为0.005%）。Access的线性范围可接受（102 - 115%），但AutoDELFIA在低促甲状腺激素浓度时不可接受（促甲状腺激素值为0.48 mIU/l时为143%）。AutoDELFIA与Access之间的相关性良好（r = 0.999）。我们得出结论，两种自动化免疫分析方法均具有良好的可靠性、实用性和性能特征。
