Dinesen B, Feddersen C
Thromb Res. 1983 Sep 1;31(5):707-18. doi: 10.1016/0049-3848(83)90101-9.
For the purposes of prenatal diagnosis and carrier detection of haemophilia A, an enzyme linked immunosorbent assay (ELISA) was developed for the quantitation of plasma Factor VIII coagulant antigen (VIII:CAg). It is based upon a human antibody. Results are compared to assays for Factor VIII coagulant activity (VIII:C) and Factor VIII related antigen (VIIIR:Ag) in plasma from 30 normal female individuals, 5 fetuses from mothers normal with respect to bleeding status, 10 obligate carriers of haemophilia A, 10 patients with haemophilia A, 5 with von Willebrand's disease, and 5 with haemophilia B. The ELISA developed is simpler than previously published VIII:CAg methods owing to its use of total IgG instead of immunologically affinity-purified antibodies. It is specific (as judged from clinical results), sensitive (detection limit: 0.005 units/ml), and sufficiently precise (between-assay coefficient of variation: 11%) for the purposes mentioned. The coefficient of correlation between VIII:CAg and VIII:C results is 0.86. The introduction of ELISA for quantitating VIII:CAg represents an advantage as compared to existing immunoradiometric assays (IRMA) mainly due to the stable and non-radioactive reagents used in the ELISA.
为了进行甲型血友病的产前诊断和携带者检测，开发了一种酶联免疫吸附测定法（ELISA）用于定量血浆凝血因子VIII凝血抗原（VIII:CAg）。该方法基于一种人源抗体。将结果与来自30名正常女性个体、5名出血状态正常母亲所生胎儿、10名甲型血友病携带者、10名甲型血友病患者、5名血管性血友病患者和5名乙型血友病患者血浆中的凝血因子VIII凝血活性（VIII:C）和凝血因子VIII相关抗原（VIIIR:Ag）检测结果进行比较。所开发的ELISA方法比先前发表的VIII:CAg方法更简单，因为它使用的是总IgG而非免疫亲和纯化抗体。就上述目的而言，该方法具有特异性（根据临床结果判断）、敏感性（检测限：0.005单位/毫升）和足够的精密度（批间变异系数：11%）。VIII:CAg和VIII:C结果之间的相关系数为0.86。与现有的免疫放射测定法（IRMA）相比，引入ELISA定量VIII:CAg具有优势，主要是因为ELISA使用的试剂稳定且无放射性。
