Coppola R, Tombesi S, Valentini F, Alborali S, Albertini A, Mannucci P M
Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, IRCCS Maggiore Hospital, Milano, Italy.
Thromb Res. 1992 Nov 1;68(3):283-93. doi: 10.1016/0049-3848(92)90085-o.
An enzyme-linked immunoassay (ELISA) was developed for measuring human factor VII antigen using two monoclonal antibodies, one of them reacting only with fully carboxylated factor VII. This assay permits to measure factor VII antigen in concentrations ranging from 0.78 to 100 ng/ml, with within- and between-assay coefficients of variation of less than 7%. In 53 normal subjects, 32 patients with liver cirrhosis, 21 pregnant women and 53 patients on oral anticoagulant therapy the plasma levels of FVII antigen were very similar to those of factor VII coagulant activity measured with a bioassay. The ELISA also gave very similar values of factor VII antigen in plasma and in serum, and in plasma before and after exposure to cold, indicating that the assay is not affected by factor VII activation. In five of 8 patients with severe congenital deficiency of factor VII values of factor VII antigen were higher than those of factor VII activity. The close concordance of factor VII values obtained by ELISA and bioassay in the majority of plasmas, including those from patients on oral anticoagulant therapy, indicates that the assay measures native factor VII and can perhaps replace the bioassay systems in clinical conditions associated with normal or high levels of factor VII.
利用两种单克隆抗体开发了一种酶联免疫吸附测定（ELISA）法，用于检测人凝血因子VII抗原，其中一种单克隆抗体仅与完全羧化的凝血因子VII发生反应。该检测方法能够测定浓度范围在0.78至100 ng/ml之间的凝血因子VII抗原，批内和批间变异系数均小于7%。在53名正常受试者、32名肝硬化患者、21名孕妇和53名接受口服抗凝治疗的患者中，FVII抗原的血浆水平与通过生物测定法测得的凝血因子VII凝血活性水平非常相似。ELISA法测得的血浆和血清中以及冷暴露前后血浆中的凝血因子VII抗原值也非常相似，这表明该检测不受凝血因子VII激活的影响。在8名严重先天性凝血因子VII缺乏患者中，有5名患者的凝血因子VII抗原值高于凝血因子VII活性值。ELISA法和生物测定法在大多数血浆中获得的凝血因子VII值高度一致，包括接受口服抗凝治疗患者的血浆，这表明该检测方法测定的是天然凝血因子VII，在与正常或高水平凝血因子VII相关的临床情况下，可能可以替代生物测定系统。
