West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, Sichuan, China.
West China-PUMC C.C. Chen Institute of Health, Sichuan University, Chengdu, Sichuan, China.
Front Endocrinol (Lausanne). 2023 Jan 6;13:1046381. doi: 10.3389/fendo.2022.1046381. eCollection 2022.
The reference intervals (RIs) are of great importance for physicans to determine whether or not an individual is healthy. However, many clinical laboratories in China still adopted the default RI provided by the manufacturers; and these "uncalibrated" RIs might lead to the misdiagnosis of diseases. In the present study, we enroll reference people with the purpose of determining the RIs of serum triiodothyronine (T3), thyroxine (T4), free triiodothyronine (FT3), free thyroxine (FT4) and thyroid-stimulating hormone (TSH) in Chinese population, and explore the possible roles of age and sex on the levels of biomarkers.
Serum samples from 66,609 individuals who met the inclusion criteria were analyzed using an Roche Cobas E 601 hormone analyzer. The dynamic trends of biomarker were visually assessed by their concentrations over age and sex. Specific partitions were determined by the method of Harris and Boyd. RIs, corresponding to the 2.5th and 97.5th percentiles, as well as the 0.5th, 25th, 50th, 75th and 99.5th percentiles were calculated for each reference partition using a non-parametric rank approach.
The serum level of T3, T4, FT4 or TSH showed a right-skewed distribution in both males and females while FT3 presented an approximate normal distribution. Females had a higher mode value of serum T3 or T4, but a lower mode value of serum TSH, FT3 or FT4. All five biomarkers did not need age partitioning according to the approach of harris and boyd, while T3 and FT3 need sex partitioning.
The present study not only determined the age- and sex-specific trends of the five thyroid hormones, but provided sex-stratified RIs for T3 and FT3, valuably contributing to the current literature and timely evaluation of thyroid health and disease.
参考区间(RIs)对于医生确定个体是否健康非常重要。然而,中国许多临床实验室仍然采用制造商提供的默认 RI;这些“未校准”的 RI 可能导致疾病的误诊。在本研究中,我们招募了参考人群,目的是确定中国人群血清三碘甲状腺原氨酸(T3)、甲状腺素(T4)、游离三碘甲状腺原氨酸(FT3)、游离甲状腺素(FT4)和促甲状腺激素(TSH)的 RI,并探讨年龄和性别对生物标志物水平的可能影响。
使用罗氏 Cobas E 601 激素分析仪分析符合纳入标准的 66609 名个体的血清样本。通过观察其浓度随年龄和性别的变化趋势,直观评估生物标志物的动态变化。采用 Harris 和 Boyd 方法确定特定分区。对于每个参考分区,使用非参数秩方法计算 RI,即第 2.5 百分位数和第 97.5 百分位数,以及第 0.5 百分位数、第 25 百分位数、第 50 百分位数、第 75 百分位数和第 99.5 百分位数。
T3、T4、FT4 或 TSH 血清水平在男性和女性中均呈右偏态分布,而 FT3 呈近似正态分布。女性 T3 或 T4 血清模式值较高,而 TSH、FT3 或 FT4 血清模式值较低。根据 Harris 和 Boyd 的方法,所有五种生物标志物均无需进行年龄分区,而 T3 和 FT3 需要进行性别分区。
本研究不仅确定了五种甲状腺激素的年龄和性别特异性趋势,还提供了 T3 和 FT3 的性别分层 RI,为当前的文献和甲状腺健康及疾病的及时评估提供了有价值的参考。