Thonnart B, Messian O, Linhart N C, Bok B
Hospital Beaujon, Department of Nuclear Medicine, Clichy, France.
Clin Chem. 1988 Apr;34(4):691-5.
We report a prospective multicenter study, undertaken to compare the efficacy of 10 highly sensitive thyrotropin assay kits for the diagnosis of hyperthyroidism. Performances of the kits were compared with a reference diagnosis based on clinical examination, pertinent biological tests, and determination by an independent laboratory of the concentrations in serum of free triiodothyronine and free thyroxin. No thyrotropin determination was used in establishing this reference diagnosis. Receiver-operating characteristic curves were obtained for results from 600 patients (217 hyperthyroid and 383 euthyroid) by each kit. Even though analyses were performed out of the working range of most kits, the clinical correlation was nevertheless excellent. The best results corresponded to a sensitivity of 97.5% associated with a specificity of 96.1% and were significantly better than those obtained with all other kits. Results of this comparison depended greatly on the heterogeneity of the "normal"/"abnormal" categories. When only diffuse hyperthyroidism was considered, sensitivity and specificity were improved for all kits, and there was no significant difference among the five best kits.
我们报告了一项前瞻性多中心研究，旨在比较10种高敏促甲状腺激素检测试剂盒诊断甲状腺功能亢进症的疗效。将这些试剂盒的性能与基于临床检查、相关生物学检测以及由独立实验室测定的血清游离三碘甲状腺原氨酸和游离甲状腺素浓度所做出的参考诊断进行比较。在建立该参考诊断时未使用促甲状腺激素测定。通过每个试剂盒获得了600例患者（217例甲状腺功能亢进症患者和383例甲状腺功能正常患者）的结果的受试者工作特征曲线。尽管分析是在大多数试剂盒的工作范围之外进行的，但临床相关性仍然非常好。最佳结果对应的灵敏度为97.5%，特异性为96.1%，并且明显优于所有其他试剂盒所获得的结果。该比较结果在很大程度上取决于“正常”/“异常”类别的异质性。当仅考虑弥漫性甲状腺功能亢进症时，所有试剂盒的灵敏度和特异性均有所提高，并且五个最佳试剂盒之间没有显著差异。
