Abstract：
OBJECTIVE: Thyroid function tests are common biochemical analyses, and agreement between the routinely used immunoassays is important for diagnosis and monitoring of thyroid disease. Efforts are continuously made to align the biochemical assays, and we aimed to evaluate the agreement between immunoassays used in a clinical laboratory setting among non-pregnant and pregnant adults.
METHODS: Cross-sectional study.
METHODS: Serum samples were obtained from 192 blood donors (non-pregnant adults) and from 86 pregnant women in the North Denmark Region with no known thyroid disease.
METHODS: Each sample was used for measurement of thyroid-stimulating hormone (TSH) with the routinely used automatic immunoassays in the regional Departments of Clinical Biochemistry (Alinity, Abbott Laboratories, Cobas, Roche Diagnostics, and Atellica, Siemens Healthineers) and reported as the median with 95% confidence interval (95% CI).
RESULTS: In nonpregnant adults, the level of TSH was higher with Cobas and Atellica than with Alinity as reflected by median (Alinity: 1.39 mIU/L (95% CI: 1.30-1.51 mIU/L); Cobas: 1.57 mIU/L (95% CI: 1.48-1.75 mIU/L); Atellica: 1.74 mIU/L (95% CI: 1.61-1.83 mIU/L)). Similarly, a trend was seen towards higher median TSH with Cobas than with Alinity among pregnant women (Alinity: 1.90 mIU/L (95% CI: 1.37-2.82 mIU/L); Cobas: 2.33 mIU/L (95% CI: 1.69-3.62 mIU/L)).
CONCLUSIONS: Results of thyroid function tests obtained with different immunoassays were not interchangeable when evaluated among pregnant and non-pregnant adults. The distinct differences are relevant for clinical decision making and emphasize the necessity of clinical laboratory information when different assays are used for diagnosis and monitoring of patients with thyroid disease.
METHODS: Cross-sectional study.
METHODS: Serum samples were obtained from 192 blood donors (non-pregnant adults) and from 86 pregnant women in the North Denmark Region with no known thyroid disease.
METHODS: Each sample was used for measurement of thyroid-stimulating hormone (TSH) with the routinely used automatic immunoassays in the regional Departments of Clinical Biochemistry (Alinity, Abbott Laboratories, Cobas, Roche Diagnostics, and Atellica, Siemens Healthineers) and reported as the median with 95% confidence interval (95% CI).
RESULTS: In nonpregnant adults, the level of TSH was higher with Cobas and Atellica than with Alinity as reflected by median (Alinity: 1.39 mIU/L (95% CI: 1.30-1.51 mIU/L); Cobas: 1.57 mIU/L (95% CI: 1.48-1.75 mIU/L); Atellica: 1.74 mIU/L (95% CI: 1.61-1.83 mIU/L)). Similarly, a trend was seen towards higher median TSH with Cobas than with Alinity among pregnant women (Alinity: 1.90 mIU/L (95% CI: 1.37-2.82 mIU/L); Cobas: 2.33 mIU/L (95% CI: 1.69-3.62 mIU/L)).
CONCLUSIONS: Results of thyroid function tests obtained with different immunoassays were not interchangeable when evaluated among pregnant and non-pregnant adults. The distinct differences are relevant for clinical decision making and emphasize the necessity of clinical laboratory information when different assays are used for diagnosis and monitoring of patients with thyroid disease.
摘要：
目的：甲状腺功能检查是常见的生化分析，常规使用的免疫测定法之间的协议对于甲状腺疾病的诊断和监测很重要。不断努力使生化测定保持一致，我们旨在评估非孕妇和孕妇在临床实验室中使用的免疫测定法之间的一致性.
方法：横断面研究。
方法：血清样本来自北丹麦地区192名献血者（未怀孕的成年人）和86名孕妇，没有已知的甲状腺疾病。
方法：在区域临床生物化学部门（Alinity，雅培实验室,Cobas,罗氏诊断,还有Atellica,SiemensHealthineers)，并以95%置信区间(95%CI)的中位数报告。
结果：在未怀孕的成年人中，根据中位数(Alinity:1.39mIU/L(95%CI:1.30-1.51mIU/L);Cobas:1.57mIU/L(95%CI:1.48-1.75mIU/L);Atellica:1.74mIU/L(95%CI:1.61-1.83mIU/L)。同样，在孕妇中,Cobas的TSH中位数有高于Alinity的趋势(Alinity:1.90mIU/L(95%CI:1.37~2.82mIU/L);Cobas:2.33mIU/L(95%CI:1.69~3.62mIU/L)).
结论：在妊娠和非妊娠成人中进行评估时，使用不同免疫测定法获得的甲状腺功能检查结果不可互换。不同的差异与临床决策有关，并强调当使用不同的测定法来诊断和监测甲状腺疾病的患者时，临床实验室信息的必要性。
方法：横断面研究。
方法：血清样本来自北丹麦地区192名献血者（未怀孕的成年人）和86名孕妇，没有已知的甲状腺疾病。
方法：在区域临床生物化学部门（Alinity，雅培实验室,Cobas,罗氏诊断,还有Atellica,SiemensHealthineers)，并以95%置信区间(95%CI)的中位数报告。
结果：在未怀孕的成年人中，根据中位数(Alinity:1.39mIU/L(95%CI:1.30-1.51mIU/L);Cobas:1.57mIU/L(95%CI:1.48-1.75mIU/L);Atellica:1.74mIU/L(95%CI:1.61-1.83mIU/L)。同样，在孕妇中,Cobas的TSH中位数有高于Alinity的趋势(Alinity:1.90mIU/L(95%CI:1.37~2.82mIU/L);Cobas:2.33mIU/L(95%CI:1.69~3.62mIU/L)).
结论：在妊娠和非妊娠成人中进行评估时，使用不同免疫测定法获得的甲状腺功能检查结果不可互换。不同的差异与临床决策有关，并强调当使用不同的测定法来诊断和监测甲状腺疾病的患者时，临床实验室信息的必要性。
