Soldin Offie P, Tractenberg Rochelle E, Soldin Steven J
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.
Clin Chim Acta. 2004 Sep;347(1-2):61-9. doi: 10.1016/j.cccn.2004.03.033.
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.
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.
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.
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.
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。
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。
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。
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。