Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Head Neck. 2010 Sep;32(9):1161-6. doi: 10.1002/hed.21308.
Serum thyroglobulin (Tg) is essential in the follow-up of patients with differentiated thyroid carcinoma (DTC). However, interchangeability and standardization between Tg assays have not yet been achieved, even with the development of an international Tg standard (Certified Reference Material 457 [CRM-457]).
Serum Tg from 30 DTC patients and serially diluted CRM-457 were measured using 3 different immunoradiometric assays (IRMA-1, IRMA-2, IRMA-3). The intraclass correlation coefficient (ICC) method was used to describe the concordance of each IRMA to CRM-457.
The serum Tg measured by 3 different IRMAs correlated well (r > .85, p < .0001), but clinically relevant discrepancies were found in 13.3% of patients. IRMA-3, which claims to be standardized to CRM-457, showed the best ICC (p(1) = .98) for the CRM-457.
Hospitals caring for patients with DTC should either set their own cutoffs for IRMAs for Tg based on their patient pools, or adopt IRMAs standardized to CRM-457 and calibrate their laboratory using CRM-457.
血清甲状腺球蛋白（Tg）是随访分化型甲状腺癌（DTC）患者的重要指标。然而，即使有了国际 Tg 标准（认证参考物质 457 [CRM-457]），Tg 检测之间的可互换性和标准化仍未实现。
使用 3 种不同的免疫放射测量法（IRMA-1、IRMA-2、IRMA-3）测量 30 例 DTC 患者的血清 Tg 和连续稀释的 CRM-457。采用组内相关系数（ICC）法描述每种 IRMA 与 CRM-457 的一致性。
3 种不同的 IRMA 测量的血清 Tg 相关性良好（r>.85，p<.0001），但在 13.3%的患者中发现了临床相关的差异。声称标准化至 CRM-457 的 IRMA-3 与 CRM-457 的 ICC 最佳（p(1)=.98）。
治疗 DTC 患者的医院应根据患者群体为其 Tg 的 IRMA 设置自己的截断值，或采用标准化至 CRM-457 的 IRMA，并使用 CRM-457 校准其实验室。
