Department of Clinical Biochemistry, Royal Infirmary of Edinburgh, Edinburgh, UK.
Ann Clin Biochem. 2013 Sep;50(Pt 5):421-32. doi: 10.1177/0004563213480492. Epub 2013 Jul 11.
Serum thyroglobulin (Tg) is useful for monitoring patients with differentiated thyroid cancer (DTC) but is limited by interference from anti-Tg antibodies (TgAb). We determined Tg assay discordance between a radioimmunoassay (RIA) and one of two immunometric assays (IMA) in DTC patients over a 9-year period to gauge assay performance against evidence of recurrent/progressive DTC.
Patients with DTC monitored for >1 year attending local clinics between September 2000 and January 2010 were included. All samples were analysed for Tg using both RIA and IMA. TgAb were measured on all Tg requests made after May 2006. Bias plots comparing RIA against IMA were established to calculate a 2-SD outlier limit. Clinical records were viewed to compare discordant Tg results against clinical evidence of recurrent/progressive DTC.
Discordant Tg results were observed in 53/433 patients (12.2%). Four were discordant owing to a higher IMA result, one of which demonstrated recurrence. The remaining 49 patients demonstrated a disproportionately higher RIA result, of which four had recurrent/persistent disease. Twelve patients with a higher RIA result but no evidence of recurrence underwent thyrogen stimulation testing, which was negative in all 12. In many cases, assay discordance appeared more sensitive at indicating interference than direct measurement of TgAb.
Interference was evident with both Tg assays, such that neither could be solely relied upon to provide the correct result in the presence of TgAb. The concomitant measurement of Tg by RIA and IMA methods should be considered as an alternative to monitoring TgAb status.
血清甲状腺球蛋白(Tg)可用于监测分化型甲状腺癌(DTC)患者,但受到抗甲状腺球蛋白抗体(TgAb)的干扰。我们在 9 年期间测定了 DTC 患者中放射免疫分析(RIA)和两种免疫测定法(IMA)之间的 Tg 检测结果不一致性,以评估检测结果与复发性/进展性 DTC 的证据相比的表现。
纳入 2000 年 9 月至 2010 年 1 月期间在当地诊所接受监测>1 年的 DTC 患者。所有样本均使用 RIA 和 IMA 进行 Tg 分析。所有在 2006 年 5 月后提出的 Tg 请求均测量 TgAb。建立 RIA 与 IMA 的偏差图以计算 2-SD 异常值限。比较有分歧的 Tg 结果与复发性/进展性 DTC 的临床证据。
在 433 例患者中观察到 53 例(12.2%)不一致的 Tg 结果。其中 4 例是由于 IMA 结果较高,其中 1 例证明有复发。其余 49 例患者的 RIA 结果不成比例地较高,其中 4 例有复发/持续性疾病。12 例 RIA 结果较高但无复发证据的患者接受了甲状腺刺激素刺激试验,所有 12 例患者均为阴性。在许多情况下,与直接测量 TgAb 相比,检测结果的不一致性似乎更能灵敏地指示干扰。
两种 Tg 检测均存在干扰,因此在存在 TgAb 的情况下,均不能仅依靠其中任何一种方法提供正确的结果。同时测定 RIA 和 IMA 方法的 Tg 应被视为监测 TgAb 状态的替代方法。