Kalaria Tejas, Fenn Jonathan, Sharrod-Cole Hayley, Sanders Anna, Ford Clare, Gama Rousseau
New Cross Hospital, Black Country Pathology Services, 592016The Royal Wolverhampton NHS Trust, Wolverhampton, UK.
Russells Hall Hospital, Black Country Pathology Services, 592016The Royal Wolverhampton NHS Trust, Dudley, UK.
Ann Clin Biochem. 2021 Nov;58(6):638-645. doi: 10.1177/00045632211042560. Epub 2021 Sep 17.
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.
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.
On review of EQA data, median (IQR) Roche: Abbott TSH ratio was lower ( < 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, < 0.001). In spiking experiments, the relationship of Roche and Abbott TSH was different in TSH deplete pool spiked with WHO-IS (RocheTSH=1.13AbbottTSH-0.52) and high TSH serum (RocheTSH=1.43AbbottTSH-0.50), respectively. The Roche: Abbott TSH ratio decreased and the method agreement improved on spiking serum pools with WHO-IS.
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.
最近有报道称，使用雅培和罗氏甲状腺检测方法对甲状腺功能减退症进行诊断和潜在治疗时存在较大差异。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。
将英国甲状腺激素EQA中430至454区间的雅培和罗氏TSH方法均值与添加的TSH量进行比较。用不同浓度的高TSH混合血清和世界卫生组织第三国际TSH标准品（WHO-IS）对TSH耗尽的血清池进行加样。对四个TSH接近临床判定限值的血清池用两种浓度的WHO-IS进行加样。
回顾EQA数据，与41个未加样的样本池（1.29（1.25 - 1.31））相比，48个加样TSH的样本池（1.11（1.07 - 1.16））中罗氏与雅培TSH比值的中位数（IQR）更低（<0.001），且下降与加样TSH在样本总TSH中的占比成比例（ρ = -0.908，<0.001）。在加样实验中，用WHO-IS加样的TSH耗尽血清池（RocheTSH = 1.13 * AbbottTSH - 0.52）和高TSH血清加样的血清池（RocheTSH = 1.43 * AbbottTSH - 0.50）中，罗氏和雅培TSH的关系不同。用WHO-IS对血清池加样后，罗氏与雅培TSH比值降低，方法一致性得到改善。
雅培和罗氏TSH检测方法在人血清样本中不一致，但在用含垂体源性TSH的WHO-IS加样的样本中一致性更好。使用EQA计划提供的垂体源性TSH加样样本可能会掩盖检测方法之间临床上的显著差异。
