Black Country Pathology Services, The Royal Wolverhampton NHS Trust, Wolverhampton, UK.
Black Country Pathology Services, The Dudley Group NHS Foundation Trust, Dudley, UK.
Clin Endocrinol (Oxf). 2021 Jun;94(6):1012-1016. doi: 10.1111/cen.14423. Epub 2021 Feb 4.
We assessed the commutativity of Roche and Abbott thyroid assays in the diagnosis and management of subclinical hypothyroidism (SCH). The Roche and Abbott thyroid assays are used by approximately 75% of clinical laboratories in the UK.
Consecutive samples received from primary care on patients with SCH who had a raised thyroid-stimulating hormone (TSH) <10 mIU/L and a normal free thyroxine (fT4) from two laboratories using either Roche or Abbott thyroid assays were identified over 10 working days. Following identification, samples were analysed at the other site within 24 hours. Diagnostic and management discordance were studied using the relevant manufacturer-provided reference ranges.
We identified 93 patients with SCH (53 using the Roche assay). Roche TSH and fT4 results were respectively 40% ± 15% and 16% ± 7% higher (P < .001) compared to Abbott results. Of the 93 patients, 41 (44%) were concordant for SCH on both methods. Of the 53 patients with SCH on the Roche assays, 40 (75.5%) had normal thyroid function and 13 (24.5%) had SCH when analysed using the Abbott assays. Of the 40 patients with SCH on the Abbott assays, 28 (70%) had SCH and 12 (30%) had results indicative for levothyroxine replacement when analysed on the Roche assays. Of these 12 patients, four had TSH > 10 mIU/L, five had low fT4 and three had both.
The diagnosis and management of SCH is strikingly different when using TSH and fT4 assays provided by Abbott Laboratories and Roche Diagnostics. Clinicians and laboratorians should be aware that between-assay differences and variations in reference ranges will directly impact the diagnosis and management of subclinical hypothyroidism.
评估罗氏和雅培甲状腺检测在亚临床甲状腺功能减退症（SCH）诊断和管理中的互换性。罗氏和雅培甲状腺检测在英国约 75%的临床实验室中使用。
在 10 个工作日内，在两个实验室中连续检测到患有 SCH 的患者的样本，这些患者的促甲状腺激素（TSH）<10 mIU/L 升高且游离甲状腺素（fT4）正常，罗氏和雅培甲状腺检测各有一半患者。鉴定后，在 24 小时内在另一个地点分析样本。使用相关制造商提供的参考范围研究诊断和管理的不一致性。
我们确定了 93 例 SCH 患者（罗氏检测组 53 例）。罗氏 TSH 和 fT4 结果分别比雅培结果高 40%±15%和 16%±7%（P<0.001）。在这 93 例患者中，41 例（44%）两种方法对 SCH 均一致。在罗氏检测组的 53 例 SCH 患者中，40 例（75.5%）甲状腺功能正常，而 13 例（24.5%）在使用雅培检测分析时患有 SCH。在雅培检测组的 40 例 SCH 患者中，28 例（70%）患有 SCH，12 例（30%）在罗氏检测分析时提示需要甲状腺素替代治疗。在这 12 例患者中，4 例 TSH>10 mIU/L，5 例 fT4 低，3 例同时存在。
使用 Abbott Laboratories 和 Roche Diagnostics 提供的 TSH 和 fT4 检测试剂盒诊断和管理 SCH 的结果有明显差异。临床医生和实验室人员应该意识到，检测之间的差异和参考范围的变化将直接影响亚临床甲状腺功能减退症的诊断和管理。
