Mirjanic-Azaric Bosa, Avram Sanja, Stojakovic-Jelisavac Tanja, Stojanovic Darja, Petkovic Mira, Bogavac-Stanojevic Natasa, Ignjatovic Svetlana, Stojanov Marina
University Clinical Centre of the Republic of SrpskaBanja Luka, Bosnia and Herzegovina, Serbia.
Health Centre Laktasi, the Republic of Srpska, Bosnia and HerzegovinaSerbia.
J Med Biochem. 2017 Apr 22;36(2):137-144. doi: 10.1515/jomb-2017-0008. eCollection 2017 Apr.
The aim of this study was to determine the reference values for thyrotropin (TSH), thyroid hormones (total and free thyroxine, T4 and fT4; total and free triiodothyronine, T3 and fT3), thyroglobulin (Tg) and thyroid antibodies (thyroid peroxidase, TPOAb and thyroglobulin antibody, TgAb) in the population of the Republic of Srpska.
A total of 250 euthyroid subjects were enrolled in this study. A direct method for choosing reference subjects was used to establish reference intervals. The hormones and thyroid antibodies were measured by an electrochemiluminescence immunoassay method (ECLIA, Roche Diagnostics, Mannheim, Germany). We calculated the reference intervals by MedCalc, version 12.1.4.0 (MedCalc software, Belgium) as recommended by the IFCC (CLSI C28-A3).
Using guidelines recommended by the National Academy of Clinical Biochemistry (NACB) and based on standard statistical approaches, the reference intervals derived for TSH, fT4, T4, fT3, T3 were 0.75-5.32 mIU/L, 12.29-20.03 pmol/L, 73.49-126,30 nmol/L, 4.11-6.32 pmol/L, 1.15-2.32 nmol/L and for Tg, TPOAb, TgAb were 3.63-26.00 μg/L, <18.02 mIU/L, < 98.00 mIU/L, respectively. We found a significant difference (p<0.05) in TSH and fT3 values between different age groups as well as in T4, fT4 and fT3 values between ge nder groups.
The established reference values for the population of the Republic of Srpska were significantly different from the values recommended by the manufacturer of reagents (Roche Diagnostics). Our results showed that a laboratory needs to establish its own reference values in order to set up a proper diagnosis, as well as to treat patients successfully.
本研究的目的是确定塞族共和国人群中促甲状腺激素（TSH）、甲状腺激素（总甲状腺素和游离甲状腺素，T4和fT4；总三碘甲状腺原氨酸和游离三碘甲状腺原氨酸，T3和fT3）、甲状腺球蛋白（Tg）和甲状腺抗体（甲状腺过氧化物酶，TPOAb和甲状腺球蛋白抗体，TgAb）的参考值。
本研究共纳入250名甲状腺功能正常的受试者。采用直接选择参考对象的方法建立参考区间。采用电化学发光免疫分析法（ECLIA，德国曼海姆罗氏诊断公司）检测激素和甲状腺抗体。我们按照国际临床化学和检验医学联合会（IFCC，CLSI C28 - A3）的建议，使用MedCalc 12.1.4.0版本软件（比利时MedCalc软件）计算参考区间。
根据美国国家临床生物化学学会（NACB）推荐的指南并基于标准统计方法，得出TSH、fT4、T4、fT3、T3的参考区间分别为0.75 - 5.32 mIU/L、12.29 - 20.03 pmol/L、73.49 - 126.30 nmol/L、4.11 - 6.32 pmol/L、1.15 - 2.32 nmol/L，Tg、TPOAb、TgAb的参考区间分别为3.63 - 26.00 μg/L、<18.02 mIU/L、<98.00 mIU/L。我们发现不同年龄组之间TSH和fT3值存在显著差异（p<0.05），不同性别组之间T4、fT4和fT3值也存在显著差异。
塞族共和国人群建立的参考值与试剂制造商（罗氏诊断公司）推荐的值有显著差异。我们的结果表明，实验室需要建立自己的参考值，以便进行准确诊断并成功治疗患者。
