Sgoutas D S, Tuten T E, Verras A A, Love A, Barton E G
Pathology Department, Emory University, Medical School, Atlanta, GA 30322, USA.
Clin Chem. 1995 Nov;41(11):1637-43.
We studied a new commercially available thyrotropin (TSH) assay, the AquaLite Bioluminescence TSH-Immunoassay (SeaLite Inc.). This assay has a detection limit of 0.005 mIU/L and a functional sensitivity of 0.017 mIU/L and meets the requirements of a third-generation TSH assay. Using this assay, we measured serum TSH in 153 euthyroid individuals and in the following patients: 32 primary hypothyroids; 38 primary hyperthyroids; 35 with thyroid cancer receiving suppressive therapy with levothyroxine (L-T4); 33 receiving replacement L-T4 aimed at reaching and maintaining a euthyroid status; 23 with subclinical hyperthyroidism; and 52 hospitalized for nonthyroidal illnesses (NTI). The AquaLite TSH assay perfectly discriminated hypothyroid and untreated hyperthyroid patients from euthyroid subjects and clearly discriminated between overtly and mildly hyperthyroid patients. Intermethod comparisons showed that the AquaLite and the Nichols assays were more effective than the ACS-180 and the TOSOH assays in discriminating among hyperthyroid patients, including patients over-treated with L-T4.
我们研究了一种新的市售促甲状腺激素（TSH）检测方法，即AquaLite生物发光TSH免疫分析方法（SeaLite公司）。该检测方法的检测限为0.005 mIU/L，功能灵敏度为0.017 mIU/L，符合第三代TSH检测方法的要求。我们使用该检测方法对153名甲状腺功能正常的个体以及以下患者的血清TSH进行了测量：32例原发性甲状腺功能减退患者；38例原发性甲状腺功能亢进患者；35例接受左甲状腺素（L-T4）抑制治疗的甲状腺癌患者；33例接受旨在达到并维持甲状腺功能正常状态的L-T4替代治疗的患者；23例亚临床甲状腺功能亢进患者；以及52例因非甲状腺疾病（NTI）住院的患者。AquaLite TSH检测方法能够完美地区分甲状腺功能减退和未经治疗的甲状腺功能亢进患者与甲状腺功能正常的受试者，并且能够清晰地区分显性和轻度甲状腺功能亢进患者。方法间比较表明，在区分甲状腺功能亢进患者（包括L-T4治疗过度的患者）方面，AquaLite和Nichols检测方法比ACS-180和TOSOH检测方法更有效。
