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市售发光增强酶免疫测定法与内部非放射性同位素法测定甲状腺素结合球蛋白和总甲状腺素的比较。

A comparison of commercially available luminescence enhanced enzyme immunoassays with in-house non-radioisotopic assays for thyroxine binding globulin and total thyroxine.

作者信息

Wood W G, Rohde C, Jacobs A

机构信息

Klinische Laboratorien, Medizinische Universität zu Lübeck.

出版信息

J Clin Chem Clin Biochem. 1988 Mar;26(3):135-40. doi: 10.1515/cclm.1988.26.3.135.

Abstract

Commercial luminescence enhanced enzyme immunoassays (Amersham-Amerlite) for thyroxine binding globulin (TBG) and total thyroxine (TT4) were compared with the in-house methods (TT4--Abbott TDx, TBG--Immunoluminometric Assay (ILMA)). The experimental groups consisted of 108 healthy euthyroid blood donors, 165 non-selected thyroid outpatients, 44 tumour bearers and 84 haemodialysis patients. Total thyroxine/thyroxine binding globulin quotients were constructed as an index of thyroid function. The luminescence enhanced enzyme immunoassays were precise (interassay coefficients of variation less than 10% in the range 5-45 mg/l thyroxine binding globulin and 20-100 micrograms/l for total thyroxine) performed similarly to the in-house methods in the differentiation of eu-, hypo- and hyperthyroidism on the basis of total thyroxine/thyroxine binding globulin quotients. Although statistically significant differences often occurred in comparisons of the in-house method with the luminescence enhanced enzyme immunoassays, these only gave rise to thyroid status differences in two cases out of 273, where the in-house method gave a hyperthyroid, the luminescence enhanced enzyme immunoassay a euthyroid answer, when taken from the total thyroxine/thyroxine binding globulin quotients. The luminescence enhanced enzyme immunoassays performed as well as the in-house methods, and quality assessment data were comparable with their radioimmunological counterparts.

摘要

将用于甲状腺素结合球蛋白(TBG)和总甲状腺素(TT4)的商业发光增强酶免疫测定法(Amersham-Amerlite)与内部方法(TT4 - Abbott TDx,TBG - 免疫发光测定法(ILMA))进行了比较。实验组包括108名健康甲状腺功能正常的献血者、165名未经选择的甲状腺门诊患者、44名肿瘤患者和84名血液透析患者。构建总甲状腺素/甲状腺素结合球蛋白商数作为甲状腺功能指标。发光增强酶免疫测定法精确(甲状腺素结合球蛋白浓度在5 - 45mg/l范围内以及总甲状腺素浓度在20 - 100μg/l范围内时,批间变异系数小于10%),基于总甲状腺素/甲状腺素结合球蛋白商数在区分甲状腺功能正常、减退和亢进方面与内部方法表现相似。尽管内部方法与发光增强酶免疫测定法比较时常常出现统计学上的显著差异,但在273例中仅有2例因这些差异导致甲状腺状态判断不同,即从总甲状腺素/甲状腺素结合球蛋白商数来看,内部方法判断为甲状腺功能亢进,而发光增强酶免疫测定法判断为甲状腺功能正常。发光增强酶免疫测定法与内部方法表现相当,质量评估数据与其放射免疫法对应数据具有可比性。

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