The Clinical Laboratory Center, The Tumor Hospital Affiliated to Xin Jiang Medical University, Urumqi, China.
J Endocrinol Invest. 2014 Mar;37(3):277-84. doi: 10.1007/s40618-013-0031-z. Epub 2014 Jan 9.
To establish reference intervals using an optimized statistical method by collecting available laboratory data of thyroid stimulating hormone (TSH), and then to verify with the laboratory-present reference intervals.
TSH RIs of the total population and different races, genders, age, source of sample are established through improved Hoffmann and Katayev's method with TSH test results data from Jan 2010 to April 2012 were collected, and finally conduct comparative verification with the laboratory present RIs.
According to the improved method, we get various RIs of different sample populations. On comparing with the laboratory current RI (0.270-4.200 mIU/L) most reference change values (RCV) were within acceptable limits. Only lower limit of Han male, Uygur male and out-patient male populations outwith acceptable limits. On excluding the different values, finally, the new RI by the optimized statistical method is 0.233-4.979 mIU/L. Because the new RI expanded the current RI and was not different from the current RI, it was indicated that new RI could be used to verify the laboratory current RIs and seen as the current RI's confidence interval (CI).
TSH RIs established by optimized Hoffmann's and Katayev's methods is viable and can be used to verify RIs provided by manufacturers or other laboratories.
通过收集现有的促甲状腺激素（TSH）实验室数据，采用优化的统计方法建立参考区间，并与实验室当前的参考区间进行验证。
采用改进的 Hoffmann 和 Katayev 方法，收集 2010 年 1 月至 2012 年 4 月的 TSH 检测结果数据，建立总人群及不同种族、性别、年龄、样本来源的 TSH 参考区间，并与实验室目前的参考区间进行比较验证。
根据改进的方法，我们得到了不同样本人群的各种参考区间。与实验室当前的 RI（0.270-4.200 mIU/L）相比，大多数参考变化值（RCV）在可接受范围内。只有汉族男性、维吾尔族男性和门诊男性的参考下限超出了可接受范围。排除不同值后，最终优化统计方法得到的新 RI 为 0.233-4.979 mIU/L。由于新 RI 扩展了当前 RI，且与当前 RI 无差异，表明新 RI 可用于验证实验室当前 RI，并可视为当前 RI 的置信区间（CI）。
采用优化的 Hoffmann 和 Katayev 方法建立的 TSH 参考区间是可行的，可以用于验证制造商或其他实验室提供的 RI。
