ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT 84108, USA.
Clin Chem. 2013 Jun;59(6):982-90. doi: 10.1373/clinchem.2012.195594. Epub 2013 Feb 8.
Measurement of serum thyroglobulin (Tg) is used to monitor patients after treatment for differentiated thyroid carcinoma (TC). Difficulty in using Tg as a biomarker of the recurrence of TC in many patients stems from the presence of endogenous anti-Tg autoantibodies (Tg-AAbs), which can interfere with immunoassays (IAs) and cause false-negative results.
We enriched Tg from serum samples using rabbit polyclonal anti-Tg antiserum and protein precipitation. Unrelated proteins were partially depleted in the process. Enriched proteins were then denatured, reduced, and digested with trypsin after the addition of a winged internal standard peptide. A Tg-specific tryptic peptide was purified by immunoaffinity extraction and analyzed by 2-dimensional LC-MS/MS. Instrument cycle time was 6.5 min per sample.
The lower limit of quantification was 0.5 ng/mL (0.76 fmol/mL dimer). Total imprecision of triplicate measurements in serum samples over 5 days was <10%. Comparison with a commercial IA using serum samples free of Tg-AAb (n = 73) showed Deming regression, IA = 1.00 * LC-MS/MS - 2.35, r = 0.982, standard error of the estimate (S(y|x)) = 9.52. In a set of Tg-AAb-positive samples that tested negative for Tg using IA (n = 71), concentrations determined by LC-MS/MS were ≥0.5 ng/mL in 23% of samples (median 1.2, range 0.7-11 ng/mL).
The introduced method has acceptable performance characteristics for use in clinical diagnostic applications. The most substantial disagreement between methods was observed in Tg-AAb-positive samples with concentrations <2 ng/mL (determined with LC-MS/MS). The affinity-assisted enrichment strategy used for Tg in this method should be applicable to other biomarkers that have endogenous autoantibodies.
甲状腺球蛋白(Tg)的检测被用于监测分化型甲状腺癌(TC)患者的治疗后情况。在许多患者中,Tg 作为 TC 复发的生物标志物存在困难,这源于内源性抗 Tg 自身抗体(Tg-AAb)的存在,它可以干扰免疫测定(IA)并导致假阴性结果。
我们使用兔多克隆抗 Tg 抗血清和蛋白质沉淀从血清样本中富集 Tg。在此过程中,部分去除了无关的蛋白质。然后,在添加翼状内部标准肽后,将富集的蛋白质变性、还原并使用胰蛋白酶进行消化。通过免疫亲和提取对 Tg 特异性胰蛋白酶肽进行纯化,并通过二维 LC-MS/MS 进行分析。仪器循环时间为每个样品 6.5 分钟。
定量下限为 0.5ng/mL(二聚体为 0.76fmol/mL)。在 5 天内对血清样本进行三次重复测量的总不精密度<10%。与无 Tg-AAb 的血清样本(n=73)的商业 IA 进行比较,显示出 Deming 回归,IA=1.00*LC-MS/MS-2.35,r=0.982,估计值的标准误差(S(y|x))=9.52。在一组使用 IA 检测为 Tg-AAb 阳性但 Tg 检测为阴性的样本(n=71)中,通过 LC-MS/MS 确定的浓度在 23%的样本中≥0.5ng/mL(中位数 1.2ng/mL,范围 0.7-11ng/mL)。
所介绍的方法具有可接受的性能特征,可用于临床诊断应用。方法之间最显著的差异是在 Tg-AAb 阳性且浓度<2ng/mL 的样本中(用 LC-MS/MS 测定)。该方法中用于 Tg 的亲和力辅助富集策略应适用于其他具有内源性自身抗体的生物标志物。