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High-Sensitivity Human Thyroglobulin (hTG) Immunoradiometric Assay in the Follow-up of Patients with Differentiated Thyroid Cancer

  • Luca Giovanella and Luca Ceriani
Published/Copyright: June 1, 2005
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Volume 40 Issue 5

Abstract

Circulating human thyroglobulin (hTG) measurement has a pivotal role in the management of patients affected by differentiated thyroid cancer (DTC). Generally, hTG serum concentration less than 1 ng/ml is considered a marker of complete remission after total thyroid ablation. Recently, high-sensitivity immunoradiometric assays (IRMA) have been developed to detect very low hTG serum concentrations. The present study was undertaken to test a newly developed high-sensitivity hTG IRMA and to evaluate its diagnostic performance and reproducibility in the follow-up of patients affected by DTC. We retrospectively selected 156 patients without signs of recurrence and 39 patients with DTC recurrence. Serum samples were collected during L-thyroxine (T4) suppressive therapy (ONT4) and 4 weeks after T4 withdrawal (OFFT4), and hTG was measured by a specific high-sensitivity IRMA (DYNOtest® Tg-plus, BRAHMS Diagnostica GmbH, Berlin, Germany). Sera showing the presence of antibodies against hTG (AbhTG) or hTG-recovery less than 80% were excluded from the study. The receiver operator characteristic (ROC) curve analysis was performed to select the best cut-off levels, and diagnostic performance of the marker was evaluated. By using ONT4 cut-off level of 0.2 ng/ml and OFFT4 cut-off level of 0.5 ng/ml we obtained a sensitivity/specificity/accuracy profile of 0.92/0.98/0.97 and 0.97/0.98/0.98, respectively. We found false-negative results in three (12%) and one (4%) out of 24 patients with cervical recurrence by using 0.2 and 0.5 ng/ml cut-off levels, respectively. However, we found false-negative results in 13 (54%) and six (25%) patients when 1.0 ng/ml cutoff level was used. Finally, DYNOtest® Tg-plus showed a very satisfactory intra- and inter-assay reproducibility in the very low hTG concentration range. Based on our data, we conclude that DYNOtest® Tg-plus assay is effective and accurate in evaluation of patients with DTC.

:
Published Online: 2005-06-01
Published in Print: 2002-06-06

Copyright (c) 2002 by Walter de Gruyter GmbH & Co. KG

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https://doi.org/10.1515/CCLM.2002.083

Articles in the same Issue

  1. XV Latin American Congress of Clinical Biochemistry, Florianópolis, Brazil, 1–5 July 2001
  2. A Method to Detect the G894T Polymorphism of the NOS3 Gene. Clinical Validation in Familial Hypercholesterolemia
  3. Increasing the Sensitivity of Single-Strand Conformation Polymorphism Analysis of the LDLR Gene Mutations in Brazilian Patients with Familial Hypercholesterolemia
  4. Hormone Replacement Therapy in Postmenopausal Women and Its Effects on Plasma Lipid Levels
  5. The Effect of N-Acetylcysteine Supplementation upon Viral Load, CD4, CD8, Total Lymphocyte Count and Hematocrit in Individuals Undergoing Antiretroviral Treatment
  6. An Evaluation of Antiretroviral Therapy Associated with α-Tocopherol Supplementation in HIV-infected Patients
  7. Effects of Re-education in Eating Habits and Physical Activity on the Lipid Profile of Obese Teenagers
  8. Myeloperoxidase-mediated Protein Oxidation: Its Possible Biological Functions
  9. Novel Haptoglobin Insertion/Deletion Polymorphism Is Associated with the Lipid Profile and C-Reactive Protein (CRP) Concentration
  10. Apolipoprotein E2/E2 Genotype in Combination with Mutations in the LDL Receptor Gene Causes Type III Hyperlipoproteinemia
  11. High-Sensitivity Human Thyroglobulin (hTG) Immunoradiometric Assay in the Follow-up of Patients with Differentiated Thyroid Cancer
  12. Tissue Transglutaminase-Serology Markers for Coeliac Disease
  13. Serum Adenosine Deaminase and Cytidine Deaminase Activities in Patients with Systemic Lupus Erythematosus
  14. Effects of Oral N-Acetylcysteine on Plasma Homocysteine and Whole Blood Glutathione Levels in Healthy, Non-pregnant Women
  15. Evaluating Sequential Values Using Time-adjusted Biological Variation
  16. High-dose Methylprednisolone Therapy in Multiple Sclerosis Increases Serum Uric Acid Levels
  17. Evaluation of Accuracy and Uncertainty of ELISA Assays for the Determination of Interleukin-4, Interleukin-5, Interferon-γ and Tumor Necrosis Factor-α
  18. Development of Immunoturbidimetric Assays for Fourteen Human Serum Proteins on the Hitachi 912™
  19. Multicenter Evaluation of a Fully Mechanized Soluble Transferrin Receptor Assay on the Hitachi and Cobas Integra Analyzers. The Determination of Reference Ranges
  20. IFCC News: May/June 2002
  21. Meetings and Awards
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