Gadsden R H, Cate J C
Department of Pathology and Laboratory Medicine, Medical University of South Carolina, Charleston 29425.
Ann Clin Lab Sci. 1991 Jul-Aug;21(4):246-53.
Serum alpha-fetoprotein (s.AFP) has been established as a useful tool in monitoring of high-risk pregnancies, as an indicator of fetal neural tube defects, and has been used as an adjunct tumor marker and for monitoring therapeutic efficacy in the treatment of certain tumors. To date, the methods for measuring s.AFP are based upon the immunologic principle and are manual methods. The purpose here is to relate the evaluation of two automated systems for the assay of s.AFP. The automated systems are based upon the following immunoassay methods: a microparticle capture enzyme separation and final quantitation by reflectance fluorescence, and a solid phase 'sandwich' separation coupled with enzyme activity measurement (EIA). The reference method is a competitive binding radioimmunoassay. It has been found by us that the automated methods directly transfer analytically with the manual assay. All methods are referenced to the same standard (WHO 1st Intl. Std. for AFP 72/225).
血清甲胎蛋白（s.AFP）已成为监测高危妊娠、作为胎儿神经管缺陷指标的有用工具，并且已被用作辅助肿瘤标志物，以及用于监测某些肿瘤治疗的疗效。迄今为止，测量s.AFP的方法基于免疫原理，且为手工方法。本文的目的是阐述对两种用于s.AFP测定的自动化系统的评估。这些自动化系统基于以下免疫测定方法：一种通过反射荧光进行微粒捕获酶分离和最终定量的方法，以及一种结合酶活性测量的固相“夹心”分离方法（酶免疫测定）。参考方法是竞争性结合放射免疫测定法。我们发现自动化方法在分析上可直接与手工测定方法转换。所有方法均参照同一标准（世界卫生组织甲胎蛋白第1国际标准品72/225）。
