Richardson S C, Papaevangelou G, Roumeliotou-Karayannis A
J Biol Stand. 1985 Apr;13(2):101-6. doi: 10.1016/s0092-1157(85)80014-7.
We examine sources of potential bias in the estimation of antibody to hepatitis B surface antigen concentrations by a calibration curve for conversion of RIA units to international units. We show by calculation and example that very large biases may exist, whereas accurate estimation is needed in screening programmes and in clinical trials for the evaluation of the immunogenicity of various types and schedules of hepatitis B vaccine. It is recommended that the danger of large biases be avoided by using the laboratory's own calibration curve, calibrated against dilutions of the WHO standard, using a standard as positive control in the radioimmunoassay. Furthermore, serum samples should be diluted to a concentration close to that of the positive control.
我们通过将放射免疫分析（RIA）单位转换为国际单位的校准曲线，研究了乙型肝炎表面抗原抗体浓度估计中潜在偏差的来源。我们通过计算和实例表明，可能存在非常大的偏差，而在筛查计划和评估各种类型及接种方案的乙型肝炎疫苗免疫原性的临床试验中，需要进行准确估计。建议通过使用实验室自身根据世界卫生组织标准稀释液校准的校准曲线，并在放射免疫分析中使用标准品作为阳性对照，来避免出现大偏差的风险。此外，血清样本应稀释至接近阳性对照的浓度。
