Zöphel K, Pinkert J, Wunderlich G, Grüning T, Franke W G
Klinik und Poliklinik für Nuklearmedizin, Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden, Deutschland.
Nuklearmedizin. 1999;38(5):150-5.
The development of highly sensitive, nonradioimmunometric assays for the measurement of thyrotropin (TSH) during the last few years have improved the measurement of low TSH values and thus benefit the diagnosis of thyroid function disorders. These third or fourth generation assays are especially popular in laboratories not accustomed to the use of radioactive tracers and can be easily automatized.
This study investigates whether these new assays provide an advantage in routine diagnosis of thyroid disorders.
TSH was measured in 150 patients with various thyroid pathology using an immunoradiometric assay (IRMA) as well as a highly sensitive luminometric assay (LUMI), both by B.R.A.H.M.S. Diagnostica. We used the current modern IRMA (available since 1997) TSH was below 0.4 mU/l, between 0.4 and 4.0 mU/l, and above 4.0 mU/l in a third of the patients in each group, respectively.
As expected the results obtained with LUMI and IRMA correlated well for TSH values above 0.1 mU/l and less well between 0.1 and 0.01 mU/l. There was no correlation between the two types of assay at TSH concentrations below 0.01 mU/l. This shows that measurements using both types of assay become increasingly less precise below 0.1 mU/l.
Both types of assay gave an identical estimate of thyroid function in every single patient. Use of the LUMI did not give additional information leading to a change in patient management. Therefore, TSH measurement using IRMA does still meet today's routine clinical requirements.
在过去几年中,用于测量促甲状腺激素(TSH)的高灵敏度非放射免疫测定法的发展,改善了低TSH值的测量,从而有利于甲状腺功能障碍的诊断。这些第三代或第四代测定法在不习惯使用放射性示踪剂的实验室中特别受欢迎,并且可以很容易地实现自动化。
本研究调查这些新的测定法在甲状腺疾病的常规诊断中是否具有优势。
使用免疫放射测定法(IRMA)以及高灵敏度发光测定法(LUMI),对150例患有各种甲状腺疾病的患者进行TSH测量,这两种方法均由B.R.A.H.M.S. Diagnostica公司提供。我们使用了当前的现代IRMA(自1997年起可用),TSH低于0.4 mU/l、在0.4至4.0 mU/l之间以及高于4.0 mU/l的患者分别占每组患者的三分之一。
正如预期的那样,对于TSH值高于0.1 mU/l的情况,LUMI和IRMA获得的结果相关性良好;而在0.1至0.01 mU/l之间,相关性则较差。在TSH浓度低于0.01 mU/l时,两种测定法之间没有相关性。这表明,在低于0.1 mU/l时,使用这两种测定法进行的测量精度越来越低。
两种测定法对每一位患者的甲状腺功能评估都是相同的。使用LUMI并没有提供导致患者管理改变的额外信息。因此,使用IRMA测量TSH仍然满足当今的常规临床需求。