Sheehan C P, Christofides N D
Amerlite Diagnostics Ltd., Cardiff Laboratories, Whitchurch, U.K.
Clin Chem. 1992 Jan;38(1):19-25.
The technical and diagnostic performance of a labeled antibody radioassay for free thyroxin (Amerlex-MAB* FT4) was examined in a multicenter trial. The overall mean within-assay precision (CV) in eight centers was 6.2% at 30 pmol/L and 3.6% at 13 pmol/L concentrations of FT4. Between-assay precision was 5.4% at 18 pmol/L and 6.8% at 50 pmol/L. The euthyroid central 95% reference range for FT4 was 11.3 to 24.3 pmol/L. Results of the method correlated well with those of an analog radioimmunoassay: [Amerlex-MAB* FT4] = 1.09 [Amerlex-M FT4] + 1.50 pmol/L (r = 0.96, n = 732). Clinical performance of the assay was better than that of first-generation analog tracer assays for sera from patients with nonthyroidal illness or binding-protein abnormalities.
在一项多中心试验中，对一种用于游离甲状腺素的标记抗体放射分析方法（Amerlex-MAB* FT4）的技术性能和诊断性能进行了检测。在八个中心，当游离甲状腺素（FT4）浓度为30 pmol/L时，批内精密度的总体均值（变异系数）为6.2%，当FT4浓度为13 pmol/L时为3.6%。批间精密度在FT4浓度为18 pmol/L时为5.4%，在50 pmol/L时为6.8%。FT4甲状腺功能正常的中央95%参考范围为11.3至24.3 pmol/L。该方法的结果与一种类似放射免疫分析方法的结果相关性良好：[Amerlex-MAB* FT4] = 1.09 [Amerlex-M FT4] + 1.50 pmol/L（r = 0.96，n = 732）。对于患有非甲状腺疾病或结合蛋白异常的患者的血清，该分析方法的临床性能优于第一代类似示踪剂分析方法。
