免疫化学发光法和免疫放射分析法检测分化型甲状腺癌血清甲状腺球蛋白的性能评估

Performance Evaluation of the Serum Thyroglobulin Assays With Immunochemiluminometric Assay and Immunoradiometric Assay for Differentiated Thyroid Cancer.

作者信息

Cho Yoon Young, Chun Sejong, Lee Soo Youn, Chung Jae Hoon, Park Hyung Doo, Kim Sun Wook

机构信息

Division of Endocrinology & Metabolism, Department of Medicine, Thyroid Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

Department of Laboratory Medicine & Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

出版信息

Ann Lab Med. 2016 Sep;36(5):413-9. doi: 10.3343/alm.2016.36.5.413.

DOI:10.3343/alm.2016.36.5.413

PMID:27374705

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4940483/

Abstract

BACKGROUND

Measurement of postoperative serum thyroglobulin (Tg) is important for detecting persistent or recurrent differentiated thyroid cancer. We evaluated the analytic performance of the DxI 800 assay (Beckman Coulter, USA) for serum Tg and anti-thyroglobulin antibodies (TgAbs) in comparison with that of the GAMMA-10 assay (Shinjin Medics Inc., Korea) for serum Tg and RIA-MAT 280 assay (Stratec, Germany) for TgAb.

METHODS

We prospectively collected blood samples from 99 patients thyroidectomized for thyroid cancer. The functional sensitivity was investigated in standards and human serum. Precision and linearity were evaluated according to the guidelines of the Clinical and Laboratory Standards Institute. The correlation between the two assays was assessed in samples with different Tg ranges.

RESULTS

The functional sensitivity of the DxI 800 assay for serum Tg was between 0.0313 and 0.0625 ng/mL. The total CV was 3.9-5.6% for serum Tg and 5.3-6.9% for serum TgAb. The coefficient of determination (R²) was 1.0 and 0.99 for serum Tg and TgAb, respectively. The cut-offs for serum TgAb were 4.0 IU/mL (DxI 800) and 60.0 IU/mL (RIA-MAT 280), and the overall agreement was 68.7%. The correlation between the two assays was excellent; the correlation coefficient was 0.99 and 0.88 for serum Tg and TgAb, respectively.

CONCLUSIONS

The DxI 800 is a sensitive assay for serum Tg and TgAb, and the results correlated well with those from the immunoradiometric assays (IRMA). This assay has several advantages over the IRMA and could be considered an alternative test for Tg measurement.

摘要

背景

术后血清甲状腺球蛋白（Tg）的检测对于发现持续性或复发性分化型甲状腺癌很重要。我们评估了DxI 800检测法（美国贝克曼库尔特公司）检测血清Tg和抗甲状腺球蛋白抗体（TgAb）的分析性能，并与检测血清Tg的GAMMA - 10检测法（韩国新进医疗公司）和检测TgAb的RIA - MAT 280检测法（德国斯特拉特公司）进行比较。

方法

我们前瞻性地收集了99例因甲状腺癌接受甲状腺切除术患者的血样。在标准品和人血清中研究功能灵敏度。根据临床和实验室标准协会的指南评估精密度和线性。在不同Tg范围的样本中评估两种检测方法之间的相关性。

结果

DxI 800检测法检测血清Tg的功能灵敏度在0.0313至0.0625 ng/mL之间。血清Tg的总变异系数为3.9 - 5.6%，血清TgAb的总变异系数为5.3 - 6.9%。血清Tg和TgAb的决定系数（R²）分别为1.0和0.99。血清TgAb的临界值分别为4.0 IU/mL（DxI 800）和60.0 IU/mL（RIA - MAT 280），总体一致性为68.7%。两种检测方法之间的相关性极佳；血清Tg和TgAb的相关系数分别为0.99和0.88。