Amsterdam UMC Location Vrije Universiteit Amsterdam, Department of Laboratory Medicine, Endocrine Laboratory, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands; Amsterdam UMC Location University of Amsterdam, Department of Laboratory Medicine, Endocrine Laboratory, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands; Amsterdam Gastroenterology, Endocrinology & Metabolism, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
Amsterdam UMC Location University of Amsterdam, Department of Laboratory Medicine, Endocrine Laboratory, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
Clin Chim Acta. 2023 Aug 1;548:117505. doi: 10.1016/j.cca.2023.117505. Epub 2023 Aug 3.
Graves' Disease (GD) is an autoimmune form of hyperthyroidism where autoantibodies are directed against the TSH-receptor (TSH-receptor antibodies; TRAb). GD is suspected if TRAb concentrations are above a pre-specified cut-off value. TRAb concentrations are measured using immunoassays. This study aimed to compare the performance of the recently implemented Alinity immunoassay to the KRYPTOR and Cobas TRAb immunoassays.
Left-over serum samples in which TRAb concentrations were measured (KRYPTOR) were used. First, TRAb stability at -20 °C for four to six years and up to five freeze-thaw cycles were assessed. Second, TRAb measurements (n = 436) were repeated using the Alinity and Cobas immunoassay and results (scored as positive/negative based on cut-off value) were compared.
TRAb results were stable over five years and up to five freeze-thaw cycles. When comparing immunoassays, 86.2% of the results were similar. Total discrepancy differed between the immunoassays (5.4% Cobas vs Alinity, 8.8% Alinity vs KRYPTOR, 13.3 % Cobas vs KRYPTOR). The KRYPTOR immunoassay showed more negative TRAb results than Cobas and Alinity.
The Alinity immunoassay showed comparable TRAb results, even though slightly more positive results compared to the KRYPTORand slightly more negative results compared to the Cobas immunoassay were seen.
Graves 病（GD）是一种自身免疫性甲状腺功能亢进症，其自身抗体针对促甲状腺激素受体（TSH 受体抗体；TRAb）。如果 TRAb 浓度超过预设的截止值，则怀疑患有 GD。TRAb 浓度使用免疫测定法测量。本研究旨在比较最近实施的 Alinity 免疫测定法与 KRYPTOR 和 Cobas TRAb 免疫测定法的性能。
使用了其中测量了 TRAb 浓度的剩余血清样本（KRYPTOR）。首先，评估了 -20°C 下长达四年和多达五个冻融循环的 TRAb 稳定性。其次，使用 Alinity 和 Cobas 免疫测定法重复测量了 436 例 TRAb 测量值，并比较了结果（根据截止值评分阳性/阴性）。
TRAb 结果在五年内且在多达五个冻融循环中保持稳定。当比较免疫测定法时，86.2%的结果相似。三种免疫测定法之间的总差异不同（Cobas 与 Alinity 为 5.4%，Alinity 与 KRYPTOR 为 8.8%，Cobas 与 KRYPTOR 为 13.3%）。KRYPTOR 免疫测定法显示的 TRAb 阴性结果比 Cobas 和 Alinity 更多。
即使与 KRYPTOR 相比，Alinity 免疫测定法显示的 TRAb 结果略为阳性，与 Cobas 免疫测定法相比，略为阴性，但结果相当。
