游离甲状腺素和促甲状腺激素全自动酶免疫测定法的批判性评估

Critical evaluation of fully automated enzyme immunoassays for free thyroxine and thyrotropin.

作者信息

Mattiazzo M, Ramasamy I

机构信息

Department of Biochemistry, Repatriation General Hospital, Daw Park, Australia.

出版信息

Eur J Clin Chem Clin Biochem. 1994 Jul;32(7):549-57. doi: 10.1515/cclm.1994.32.7.549.

DOI:10.1515/cclm.1994.32.7.549

PMID:7981337

Abstract

The technical and diagnostic performance of fully automated immunoassays for free thyroxine and thyrotropin using streptavidin/biotin technology (Enzymun-Test) were examined. The between-assay precision for free thyroxine was 10.4%, 5.4%, 2.5%, 2.3%, 1.1%, and 1.8% at 3.02, 6.27, 17.2, 21.9, 25.6, 42.7 pmol/l; and for thyrotropin was 14.2%, 4.7%, 2.9%, 2.8%, 3.2%, 4.5% at 0.12, 0.46, 1.03, 2.05, 4.8, 12.7 mU/l. The functional detection limit of the assay was 0.09 mU/l. Results for the free thyroxine method correlated well with the IMx (r = 0.91) and the equilibrium dialysis (r = 0.95) assay. Results for the thyrotropin method correlated well with the Tandem-TSH (r = 0.99) and the IMx (r = 0.99) assays. The euthyroid reference range was 11-23 pmol/l and 0.5-3.9 mU/l for free thyroxine and thyrotropin respectively. The free thyroxine assay was not influenced by changes in albumin or thyroxine binding globulin concentration but showed increases at oleic acid concentrations > 4 mmol/l. Spuriously elevated free thyroxine concentration were found in 4 patients, due to assay interference by antibodies in the serum. In a follow up study of 46 patients with non-thyroidal illness, serial measurements showed fluctuating free thyroxine and thyrotropin concentrations with abnormal results occurring in 34%. In a hospital setting, a wider range of free thyroxine (10-28 pmol/l) and thyrotropin (0.22-5.9 mU/l) concentration may be observed in patients who are clinically euthyroid. Abnormal thyroid function tests were however transient and follow up resolved most diagnostic problems.

摘要

对采用链霉亲和素/生物素技术（酶免疫检测法）的游离甲状腺素和促甲状腺激素全自动免疫分析的技术及诊断性能进行了检测。游离甲状腺素的批间精密度在3.02、6.27、17.2、21.9、25.6、42.7 pmol/l时分别为10.4%、5.4%、2.5%、2.3%、1.1%和1.8%；促甲状腺激素在0.12、0.46、1.03、2.05、4.8、12.7 mU/l时的批间精密度分别为14.2%、4.7%、2.9%、2.8%、3.2%、4.5%。该分析方法的功能检测限为0.09 mU/l。游离甲状腺素方法的结果与免疫酶联法（r = 0.91）和平衡透析法（r = 0.95）检测结果相关性良好。促甲状腺激素方法的结果与串联促甲状腺激素检测法（r = 0.99）和免疫酶联法（r = 0.99）检测结果相关性良好。甲状腺功能正常的参考范围游离甲状腺素为11 - 23 pmol/l，促甲状腺激素为0.5 - 3.9 mU/l。游离甲状腺素分析不受白蛋白或甲状腺素结合球蛋白浓度变化的影响，但在油酸浓度>4 mmol/l时会升高。4例患者因血清中抗体干扰分析而出现游离甲状腺素浓度假性升高。在一项对46例非甲状腺疾病患者的随访研究中，连续测量显示游离甲状腺素和促甲状腺激素浓度波动，34%出现异常结果。在医院环境中，临床甲状腺功能正常的患者可能观察到更宽范围的游离甲状腺素（10 - 28 pmol/l）和促甲状腺激素（0.22 - 5.9 mU/l）浓度。然而，甲状腺功能检查异常是短暂的，随访解决了大多数诊断问题。