Gow S M, Nicol K, Seth J, Caldwell G, Toft A D, Beckett G J
Ann Clin Biochem. 1987 May;24 ( Pt 3):273-8. doi: 10.1177/000456328702400306.
A new, coated well immunoradiometric assay (IRMA) for thyrotrophin (TSH) in serum has been evaluated with a view to its use as a first-line test of thyroid function. The Amerwell TSH IRMA is simple, rapid to perform (2.5 h) and the assay sensitivity was 0.07 mU/L with a working range (intra-assay CV less than 10%) of 0.3-100 mU/L. The mean inter-assay CV was 6.6% for TSH concentrations of 0.30-30.7 mU/L. The method compared favourably with an in-house TSH radioimmunoassay and an alternative commercial IRMA. In consecutive referrals to a thyroid clinic all patients with overt hyperthyroidism (n = 103) had undetectable TSH concentrations and in those with subclinical hyperthyroidism (n = 14). TSH was undetectable in 10 and below the reference range in four. The 95% confidence interval for 63 euthyroid serum samples was 0.36-4.3 mU/L. All hypothyroid patients (n = 20) had increased TSH concentrations. TSH concentrations in pregnancy did not differ significantly from euthyroid TSH values. From 1916 routine tests, 13 undetectable TSH values were found in which thyroid hormone levels were normal and the patients had no known thyroid disorder. The assay appears suitable as a first-line test of thyroid function, but further assessment in a routine laboratory setting is required.
已对一种新的用于血清促甲状腺激素（TSH）检测的包被微孔免疫放射测定法（IRMA）进行了评估，旨在将其用作甲状腺功能的一线检测方法。Amerwell TSH IRMA操作简单、快速（2.5小时），检测灵敏度为0.07 mU/L，工作范围（批内变异系数小于10%）为0.3 - 100 mU/L。对于TSH浓度为0.30 - 30.7 mU/L的样本，批间平均变异系数为6.6%。该方法与内部TSH放射免疫测定法及另一种市售IRMA相比具有优势。在连续转诊至甲状腺诊所的患者中，所有显性甲状腺功能亢进患者（n = 103）的TSH浓度均无法检测到，亚临床甲状腺功能亢进患者（n = 14）中，10例TSH无法检测到，4例低于参考范围。63例甲状腺功能正常血清样本的95%置信区间为0.36 - 4.3 mU/L。所有甲状腺功能减退患者（n = 20）的TSH浓度均升高。孕期TSH浓度与甲状腺功能正常时的TSH值无显著差异。在1916次常规检测中，发现13例TSH值无法检测到，而甲状腺激素水平正常且患者无已知甲状腺疾病。该检测方法似乎适合作为甲状腺功能的一线检测方法，但需要在常规实验室环境中进行进一步评估。
