Background

A large discordance in the diagnosis and potential management of hypothyroidism using Abbott and Roche thyroid assays has been reported recently. The difference in Abbott and Roche thyroid-stimulating hormone (TSH) results in these studies was larger than anticipated from the external quality assessment (EQA) reports.

Methods

Abbott and Roche TSH method means in UK NEQAS for thyroid hormones distributions 430 to 454 were compared against the amount of TSH spiked. A TSH deplete serum pool was spiked with various concentrations of pooled high TSH serum and 3rd WHO International Standard for TSH (WHO-IS). Four serum pools with TSH close to clinical decision limits were spiked with two concentrations of WHO-IS.

Results

On review of EQA data, median (IQR) Roche: Abbott TSH ratio was lower (p < 0.001) in 48 pools spiked with TSH (1.11 (1.07–1.16)) compared to 41 pools not spiked (1.29 (1.25–1.31)) and the decrease was proportionate to the contribution of spiked TSH to total TSH in the samples (ρ=−0.908, p < 0.001). In spiking experiments, the relationship of Roche and Abbott TSH was different in TSH deplete pool spiked with WHO-IS (RocheTSH=1.13*AbbottTSH–0.52) and high TSH serum (RocheTSH=1.43*AbbottTSH–0.50), respectively. The Roche: Abbott TSH ratio decreased and the method agreement improved on spiking serum pools with WHO-IS.

Conclusion

Abbott and Roche TSH assays are not in harmony in human serum samples but the agreement was better in samples spiked with WHO-IS which contains pituitary-derived TSH. Use of pituitary-derived TSH spiked samples, such as provided by EQA schemes, may mask clinically significant between-assay differences.

中文翻译：

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加入垂体衍生的促甲状腺激素的样品可能会掩盖促甲状腺激素检测之间的差异程度

背景

最近有报道称，使用 Abbott 和 Roche 甲状腺检测对甲状腺功能减退症的诊断和潜在管理存在很大差异。这些研究中雅培和罗氏促甲状腺激素 (TSH) 结果的差异大于外部质量评估 (EQA) 报告中的预期。

方法

在英国 NEQAS 中，雅培和罗氏 TSH 方法意味着甲状腺激素分布 430 到 454 与 TSH 加标量进行了比较。用不同浓度的高 TSH 混合血清和第 3 版 WHO TSH 国际标准 (WHO-IS) 向 TSH 耗尽血清池中添加。四个 TSH 接近临床决策限值的血清库中加入了两种浓度的 WHO-IS。

结果

在审查 EQA 数据时，与未加标的 41 个池 (1.29 (1.25-1.31)) 相比，48 个添加 TSH (1.11 (1.07-1.16)) 的池中位 (IQR) Roche: Abbott TSH 比率较低 ( p < 0.001)并且减少与样品中加标 TSH 对总 TSH 的贡献成正比（ρ=-0.908，p < 0.001）。在加标实验中，罗氏和雅培 TSH 的关系在加标 WHO-IS (RocheTSH=1.13*AbbottTSH–0.52) 和高 TSH 血清 (RocheTSH=1.43*AbbottTSH–0.50) 的 TSH 耗尽池中是不同的。罗氏：雅培 TSH 比率降低，方法一致性得到改善，使用 WHO-IS 加标血清池。

结论

雅培和罗氏 TSH 测定在人血清样本中不一致，但在加入 WHO-IS 的样本中一致性更好，其中含有垂体衍生的 TSH。使用来自垂体的 TSH 加标样品，例如 EQA 计划提供的样品，可能会掩盖临床上显着的测定间差异。