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使用同位素稀释串联质谱法和免疫测定法对孕妇和非孕妇进行甲状腺素(T4)和三碘甲状腺原氨酸(T3)测量的差异:是否具有临床意义?

Differences between measurements of T4 and T3 in pregnant and nonpregnant women using isotope dilution tandem mass spectrometry and immunoassays: are there clinical implications?

作者信息

Soldin Offie P, Tractenberg Rochelle E, Soldin Steven J

机构信息

Division of Cancer Genetics and Epidemiology, Lombardi Cancer Center, Georgetown University School of Medicine, Room S-165A, 3800 Reservoir Road, NW, Washington, DC 20007-2197, USA.

出版信息

Clin Chim Acta. 2004 Sep;347(1-2):61-9. doi: 10.1016/j.cccn.2004.03.033.

Abstract

BACKGROUND

It has been established that triiodothyronine (T3) and thyroxine (T4) measurements by tandem mass spectrometry (MS/MS) are more specific and are significantly different from immunoassay (IA) measurements (all p< or =0.05) throughout pregnancy. In this study, we examined the clinical implications of these discrepancies.

METHODS

Kappa statistics were used to determine the degree to which IA and MS/MS agreed in their identification of out-of-reference interval observations of circulating T4 and T3 from 52 normal, iodine-sufficient women during each trimester of pregnancy.

RESULTS

After taking chance agreement into account, the two methods had poor agreement on classification of T3 values at the first (kappa=0.185) and second (kappa=0.183) trimesters, with extremely poor agreement for the third trimester and 1-year postpartum. Agreement on T4 was poor only for the third trimester (kappa=0.183). The two methods agreed on out-of-range values in only 0-25% of T3 cases and 25-66.7% of T4 cases.

CONCLUSIONS

The areas of disagreement suggest that women at risk (i.e., with analyte values outside of the 5-95% range) will not be detected using IA. Based on this cohort, our preliminary estimates are that 25-100% of such women would be missed if IA were used to assay the analyte.

摘要

背景

已有研究证实,通过串联质谱法(MS/MS)测定三碘甲状腺原氨酸(T3)和甲状腺素(T4)在整个孕期更具特异性,且与免疫测定法(IA)的测量结果存在显著差异(所有p≤0.05)。在本研究中,我们探讨了这些差异的临床意义。

方法

采用kappa统计量来确定IA和MS/MS在识别52名正常、碘充足的女性孕期各阶段循环T4和T3超出参考区间观察值方面的一致程度。

结果

考虑到偶然一致性后,两种方法在孕早期(kappa = 0.185)和孕中期(kappa = 0.183)对T3值的分类一致性较差,孕晚期和产后1年的一致性极差。T4方面仅在孕晚期一致性较差(kappa = 0.183)。两种方法在T3病例中仅0 - 25%以及T4病例中25 - 66.7%的超出范围值上达成一致。

结论

存在差异的领域表明,使用IA无法检测出有风险的女性(即分析物值在5 - 95%范围之外)。基于该队列,我们的初步估计是,如果使用IA检测分析物,此类女性中有25 - 100%会被漏诊。

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