Schlienger J L, Sapin R, Grunenberger F, Gasser F, Pradignac A
Service de Médecine Interne, Hôpital de Hautepierre, Strasbourg, France.
Pathol Biol (Paris). 1993 May;41(5):463-8.
The performances of a new "3rd generation" chemoluminescence TSH assay (TSH ICMA) with a functional sensitivity of 0.005 mU/l were compared with those of an "ultrasensitive" TSH immunoradiometric assay (TSH IRMA) in a series of patients characterised by a TSH IRMA less than 0.20 mU/l and normal free thyroxin (T4 L) and triiodothyronine (T3 L) concentrations. The 95% cut-off value for hyperthyroidism was 0.03 for TSH ICMA and 0.05 for TSH IRMA. In a first group of 41 subjects undergoing Tc99m thyroid scan, images of multifocal increased uptake or toxic adenoma were associated with a lower TSH ICMA than in patients with a normal isotope scan. TSH ICMA was also lower than TSH IRMA (p < 0.01). At the cut-off value of 0.03 mU/l, the specificity of TSH ICMA was higher than that of TSH IRMA, but the sensitivity were identical. In a second group of 36 patients with severe non-thyroid diseases, TSH ICMA was lower than the cut-off value for hyperthyroidism in 30% of cases, while TSH IRMA was lower than the cut-off value in 40% of cases. A satisfactory concordance was observed between the two methods. In conclusion, the two TSH assays, IRMA and ICMA, provide globally comparable information in subjects with a low TSH and normal T4 L and T3 L. However, the better specificity of TSH ICMA and a smaller overlap with the frank hyperthyroid zone in patients with non-thyroid disease argue in favour of the use of this new assay method.
在一系列促甲状腺激素免疫放射分析(TSH IRMA)低于0.20 mU/l且游离甲状腺素(T4 L)和三碘甲状腺原氨酸(T3 L)浓度正常的患者中,对一种功能灵敏度为0.005 mU/l的新型“第三代”化学发光促甲状腺激素检测方法(TSH ICMA)与“超灵敏”促甲状腺激素免疫放射分析(TSH IRMA)的性能进行了比较。促甲状腺激素免疫化学发光法(TSH ICMA)诊断甲亢的95%临界值为0.03,促甲状腺激素免疫放射分析法(TSH IRMA)为0.05。在第一组41例接受锝99m甲状腺扫描的受试者中,多灶性摄取增加或毒性腺瘤的图像与促甲状腺激素免疫化学发光法(TSH ICMA)低于同位素扫描正常的患者。促甲状腺激素免疫化学发光法(TSH ICMA)也低于促甲状腺激素免疫放射分析法(TSH IRMA)(p<0.01)。在0.03 mU/l的临界值时,促甲状腺激素免疫化学发光法(TSH ICMA)的特异性高于促甲状腺激素免疫放射分析法(TSH IRMA),但灵敏度相同。在第二组36例患有严重非甲状腺疾病的患者中,30%的病例促甲状腺激素免疫化学发光法(TSH ICMA)低于甲亢的临界值,而40%的病例促甲状腺激素免疫放射分析法(TSH IRMA)低于临界值。两种方法之间观察到令人满意的一致性。总之,促甲状腺激素免疫放射分析法(IRMA)和免疫化学发光分析法(ICMA)这两种促甲状腺激素检测方法在促甲状腺激素水平低且T4 L和T3 L正常的受试者中提供了总体可比的信息。然而,促甲状腺激素免疫化学发光法(TSH ICMA)更好的特异性以及与非甲状腺疾病患者明显甲亢区较小的重叠支持使用这种新的检测方法。