Wilke T J, Sheedy T J, Hirning D A
J Clin Chem Clin Biochem. 1985 Jan;23(1):35-9. doi: 10.1515/cclm.1985.23.1.35.
The performance characteristics and diagnostic value of a monoclonal antibody-based radioimmunoassay for serum total thyroxine (Mallinckrodt) are described. Between-batch precision (coefficient of variation) was 10.4% at 87 nmol/l and 3.3% at 185 nmol/l. Scatchard analysis revealed a linear plot with a Ka of 5.4 X 10(8) l/mol. Sensitivity was 4.5 nmol/l of thyroxine. An association study showed that the assay reached equilibrium well within the specified incubation time. Cross-reaction of triiodothyronine and reverse triiodothyronine in the assay was 0.6% and 25.0% respectively. Analytical recovery was 91-110%. Linearity was well demonstrated but dilutions of a high concentration of thyroxine in serum did not parallel the standard curve. The correlation coefficient for comparison with a polyclonal antibody assay was 0.95 for 83 patients. The diagnostic accuracy of the monoclonal antibody assay was adequate for most patients with thyroid disease, pregnant women, oral contraceptive users and subjects on thyroxine-replacement therapy. Measurement of total thyroxine by a monoclonal antibody-based method shows no definite advantage over the conventional polyclonal antibody assay.
本文描述了一种基于单克隆抗体的血清总甲状腺素放射免疫分析方法（Mallinckrodt公司生产）的性能特征和诊断价值。批间精密度（变异系数）在87 nmol/l时为10.4%，在185 nmol/l时为3.3%。Scatchard分析显示为线性图，解离常数（Ka）为5.4×10⁸ l/mol。灵敏度为4.5 nmol/l甲状腺素。一项关联研究表明，该分析方法在规定的孵育时间内能够很好地达到平衡。该分析方法中三碘甲状腺原氨酸和反三碘甲状腺原氨酸的交叉反应分别为0.6%和25.0%。分析回收率为91% - 110%。线性关系得到很好的证明，但血清中高浓度甲状腺素的稀释液与标准曲线不平行。83例患者与多克隆抗体分析方法比较的相关系数为0.95。对于大多数甲状腺疾病患者、孕妇、口服避孕药使用者和接受甲状腺素替代治疗的患者，单克隆抗体分析的诊断准确性足够。基于单克隆抗体的方法测定总甲状腺素与传统的多克隆抗体分析方法相比没有明显优势。
