Newman D J, Kassai M, Craig A R, Gorman E G, Price C P
Department of Clinical Biochemistry, St Bartholomew's School of Medicine and Dentistry, London, UK.
Eur J Clin Chem Clin Biochem. 1996 Oct;34(10):861-5.
We describe the development and validation of a fully automated homogeneous immunoassay for serum beta 2-microglobulin on the Dade aca clinical analyzer. The assay employs latex enhanced immunoturbidimetry, with an affinity purified polyclonal antibody covalently coupled to a 40 nm latex particle. The assay working range is < 0.5 to 20 mg/l with no evidence of loss of signal due to antigen excess at concentrations up to 120 mg/l. The assay sensitivity is 0.2 mg/l; within run and between run imprecision showed coefficients of variations of < 7%, across the assay range 1-20 mg/l. A method comparison with an established RIA procedure gave a regression equation of (aca) = 1.14 (RIA)-0.26, r = 0.996, n = 109. Good analytical recovery (98-101%), no evidence of a lack of parallelism and no interference from rheumatoid factor (tested up to 1.2 x 10(6) U/l) were observed. The low method to be considered as an effective means of monitoring seroconversion in HIV infected subjects and treatment of patients with myelomatosis.
我们描述了一种在达德aca临床分析仪上用于血清β2-微球蛋白的全自动均相免疫分析方法的开发与验证。该分析方法采用乳胶增强免疫比浊法，使用一种亲和纯化的多克隆抗体共价偶联到40nm的乳胶颗粒上。该分析方法的工作范围为<0.5至20mg/l，在浓度高达120mg/l时未出现因抗原过量导致信号损失的情况。该分析方法的灵敏度为0.2mg/l；批内和批间不精密度在1-20mg/l的分析范围内变异系数均<7%。与既定的放射免疫分析程序进行方法比较，得到回归方程(aca)=1.14(RIA)-0.26，r=0.996，n=109。观察到良好的分析回收率（98-101%），无缺乏平行性的证据，且类风湿因子（检测至1.2×10(6)U/l）无干扰。该方法可被视为监测HIV感染患者血清转化和骨髓瘤患者治疗的有效手段。
