Hennes U, Jucker W, Fischer E A, Krummenacher T, Palleroni A V, Trown P W, Linder-Ciccolunghi S, Rainisio M
J Biol Stand. 1987 Jul;15(3):231-44. doi: 10.1016/0092-1157(87)90026-6.
Three different procedures have been used for detecting antibodies to Roferon-A (recombinant human interferon alfa-2a, rHuIFN alpha-2a) in the serum of patients who received this interferon as part of ongoing clinical trials: an antiviral neutralization bioassay (ANB), the standard method recommended by the World Health Organization (WHO), and the more recently developed radioimmunoassay (RIA) and enzymeimmunoassay (EIA). Although the three tests are based on different principles, the correlation among them was excellent. The assays show differences in sensitivities with the ANB being the least sensitive of the three. The EIA equals the RIA in sensitivity, reproducibility, accuracy and labor and provides the advantage of safety and convenience in the use of non-radioactive materials. Therefore, the EIA has been selected as the most suitable assay for initial screening of the sera of patients receiving Roferon-A for the presence of antibodies to this interferon. EIA positive sera are then tested in the ANB to determine whether or not neutralizing activities are present.
在正在进行的临床试验中，有三种不同的方法用于检测接受罗扰素-A（重组人干扰素α-2a，rHuIFNα-2a）治疗的患者血清中针对该干扰素的抗体：抗病毒中和生物测定法（ANB），这是世界卫生组织（WHO）推荐的标准方法，以及最近开发的放射免疫测定法（RIA）和酶免疫测定法（EIA）。尽管这三种检测方法基于不同的原理，但它们之间的相关性非常好。这些测定法在灵敏度上存在差异，其中ANB是三种方法中灵敏度最低的。EIA在灵敏度、重复性、准确性和工作量方面与RIA相当，并且具有使用非放射性材料的安全性和便利性优势。因此，EIA已被选为最适合初步筛查接受罗扰素-A治疗患者血清中是否存在针对该干扰素抗体的检测方法。然后，对EIA呈阳性的血清进行ANB检测，以确定是否存在中和活性。
