Clinical applicability of low levels of thyroglobulin autoantibodies as cutoff point for thyroglobulin autoantibody positivity

Bernadette L. Dekker, Anouk N. A. van der Horst-Schrivers, Wim J. Sluiter, Adrienne H. Brouwers, Eef G. W. M. Lentjes, Annemieke C. Heijboer, Anneke C. Muller Kobold, Thera P. Links

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Background: Thyroglobulin (Tg) is an established tumor marker in differentiated thyroid carcinoma (DTC). However, Tg assays can be subject to interference by autoantibodies against Tg (TgAbs). No clinical consensus exists on the cutoff value of TgAb positivity and its relationship to Tg assay interference. The aims of this study were to investigate the most applicable cutoff value for TgAb positivity in clinical practice and to evaluate whether tumor characteristics differ between TgAb+ and TgAb- patients during ablation therapy using the manufacturer's cutoff (MCO) and institutional cutoff (ICO). Methods: This single-center cohort study included 230 DTC patients diagnosed between January 2006 and December 2014. Serum Tg and TgAbs were measured with the Tg-IRMA (Thermo Fisher Scientific) and ARCHITECT Anti-Tg (Abbott Laboratories) assays. Patients were divided into TgAb- and TgAb+ based on the limit of detection (LoD; ≥0.07 IU/mL), functional sensitivity (FS; ≥0.31 IU/mL), MCO (≥4.11 IU/mL), and ICO (≥10 IU/mL). Results: All patients were TgAb+ based on the LoD; one patient was negative on FS. Fifty-five (23.9%) and 34 (14.8%) patients had TgAbs above the MCO and ICO, respectively. Histology, presence of multifocality, tumor-node-metastasis, and American Thyroid Assocation risk stratification did not differ between TgAb- and TgAb+ patients using MCO and ICO during ablation. Conclusions: This study supports the use of a higher cutoff value than that of the FS for TgAb positivity in clinical settings. The LoD and FS are too sensitive to discriminate TgAb positivity and negativity in DTC patients during ablation therapy. The presence of TgAbs during ablation is not related to tumor characteristics and risk profile. This implies that TgAb positivity should not be considered a separate risk factor.
Original languageEnglish
Pages (from-to)71-78
JournalThyroid
Volume29
Issue number1
DOIs
Publication statusPublished - 2019

Cite this

Dekker, B. L., van der Horst-Schrivers, A. N. A., Sluiter, W. J., Brouwers, A. H., Lentjes, E. G. W. M., Heijboer, A. C., ... Links, T. P. (2019). Clinical applicability of low levels of thyroglobulin autoantibodies as cutoff point for thyroglobulin autoantibody positivity. Thyroid, 29(1), 71-78. https://doi.org/10.1089/thy.2018.0195
Dekker, Bernadette L. ; van der Horst-Schrivers, Anouk N. A. ; Sluiter, Wim J. ; Brouwers, Adrienne H. ; Lentjes, Eef G. W. M. ; Heijboer, Annemieke C. ; Muller Kobold, Anneke C. ; Links, Thera P. / Clinical applicability of low levels of thyroglobulin autoantibodies as cutoff point for thyroglobulin autoantibody positivity. In: Thyroid. 2019 ; Vol. 29, No. 1. pp. 71-78.
@article{be32268b30c042c689f7953899dc2271,
title = "Clinical applicability of low levels of thyroglobulin autoantibodies as cutoff point for thyroglobulin autoantibody positivity",
abstract = "Background: Thyroglobulin (Tg) is an established tumor marker in differentiated thyroid carcinoma (DTC). However, Tg assays can be subject to interference by autoantibodies against Tg (TgAbs). No clinical consensus exists on the cutoff value of TgAb positivity and its relationship to Tg assay interference. The aims of this study were to investigate the most applicable cutoff value for TgAb positivity in clinical practice and to evaluate whether tumor characteristics differ between TgAb+ and TgAb- patients during ablation therapy using the manufacturer's cutoff (MCO) and institutional cutoff (ICO). Methods: This single-center cohort study included 230 DTC patients diagnosed between January 2006 and December 2014. Serum Tg and TgAbs were measured with the Tg-IRMA (Thermo Fisher Scientific) and ARCHITECT Anti-Tg (Abbott Laboratories) assays. Patients were divided into TgAb- and TgAb+ based on the limit of detection (LoD; ≥0.07 IU/mL), functional sensitivity (FS; ≥0.31 IU/mL), MCO (≥4.11 IU/mL), and ICO (≥10 IU/mL). Results: All patients were TgAb+ based on the LoD; one patient was negative on FS. Fifty-five (23.9{\%}) and 34 (14.8{\%}) patients had TgAbs above the MCO and ICO, respectively. Histology, presence of multifocality, tumor-node-metastasis, and American Thyroid Assocation risk stratification did not differ between TgAb- and TgAb+ patients using MCO and ICO during ablation. Conclusions: This study supports the use of a higher cutoff value than that of the FS for TgAb positivity in clinical settings. The LoD and FS are too sensitive to discriminate TgAb positivity and negativity in DTC patients during ablation therapy. The presence of TgAbs during ablation is not related to tumor characteristics and risk profile. This implies that TgAb positivity should not be considered a separate risk factor.",
author = "Dekker, {Bernadette L.} and {van der Horst-Schrivers}, {Anouk N. A.} and Sluiter, {Wim J.} and Brouwers, {Adrienne H.} and Lentjes, {Eef G. W. M.} and Heijboer, {Annemieke C.} and {Muller Kobold}, {Anneke C.} and Links, {Thera P.}",
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Dekker, BL, van der Horst-Schrivers, ANA, Sluiter, WJ, Brouwers, AH, Lentjes, EGWM, Heijboer, AC, Muller Kobold, AC & Links, TP 2019, 'Clinical applicability of low levels of thyroglobulin autoantibodies as cutoff point for thyroglobulin autoantibody positivity' Thyroid, vol. 29, no. 1, pp. 71-78. https://doi.org/10.1089/thy.2018.0195

Clinical applicability of low levels of thyroglobulin autoantibodies as cutoff point for thyroglobulin autoantibody positivity. / Dekker, Bernadette L.; van der Horst-Schrivers, Anouk N. A.; Sluiter, Wim J.; Brouwers, Adrienne H.; Lentjes, Eef G. W. M.; Heijboer, Annemieke C.; Muller Kobold, Anneke C.; Links, Thera P.

In: Thyroid, Vol. 29, No. 1, 2019, p. 71-78.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Clinical applicability of low levels of thyroglobulin autoantibodies as cutoff point for thyroglobulin autoantibody positivity

AU - Dekker, Bernadette L.

AU - van der Horst-Schrivers, Anouk N. A.

AU - Sluiter, Wim J.

AU - Brouwers, Adrienne H.

AU - Lentjes, Eef G. W. M.

AU - Heijboer, Annemieke C.

AU - Muller Kobold, Anneke C.

AU - Links, Thera P.

PY - 2019

Y1 - 2019

N2 - Background: Thyroglobulin (Tg) is an established tumor marker in differentiated thyroid carcinoma (DTC). However, Tg assays can be subject to interference by autoantibodies against Tg (TgAbs). No clinical consensus exists on the cutoff value of TgAb positivity and its relationship to Tg assay interference. The aims of this study were to investigate the most applicable cutoff value for TgAb positivity in clinical practice and to evaluate whether tumor characteristics differ between TgAb+ and TgAb- patients during ablation therapy using the manufacturer's cutoff (MCO) and institutional cutoff (ICO). Methods: This single-center cohort study included 230 DTC patients diagnosed between January 2006 and December 2014. Serum Tg and TgAbs were measured with the Tg-IRMA (Thermo Fisher Scientific) and ARCHITECT Anti-Tg (Abbott Laboratories) assays. Patients were divided into TgAb- and TgAb+ based on the limit of detection (LoD; ≥0.07 IU/mL), functional sensitivity (FS; ≥0.31 IU/mL), MCO (≥4.11 IU/mL), and ICO (≥10 IU/mL). Results: All patients were TgAb+ based on the LoD; one patient was negative on FS. Fifty-five (23.9%) and 34 (14.8%) patients had TgAbs above the MCO and ICO, respectively. Histology, presence of multifocality, tumor-node-metastasis, and American Thyroid Assocation risk stratification did not differ between TgAb- and TgAb+ patients using MCO and ICO during ablation. Conclusions: This study supports the use of a higher cutoff value than that of the FS for TgAb positivity in clinical settings. The LoD and FS are too sensitive to discriminate TgAb positivity and negativity in DTC patients during ablation therapy. The presence of TgAbs during ablation is not related to tumor characteristics and risk profile. This implies that TgAb positivity should not be considered a separate risk factor.

AB - Background: Thyroglobulin (Tg) is an established tumor marker in differentiated thyroid carcinoma (DTC). However, Tg assays can be subject to interference by autoantibodies against Tg (TgAbs). No clinical consensus exists on the cutoff value of TgAb positivity and its relationship to Tg assay interference. The aims of this study were to investigate the most applicable cutoff value for TgAb positivity in clinical practice and to evaluate whether tumor characteristics differ between TgAb+ and TgAb- patients during ablation therapy using the manufacturer's cutoff (MCO) and institutional cutoff (ICO). Methods: This single-center cohort study included 230 DTC patients diagnosed between January 2006 and December 2014. Serum Tg and TgAbs were measured with the Tg-IRMA (Thermo Fisher Scientific) and ARCHITECT Anti-Tg (Abbott Laboratories) assays. Patients were divided into TgAb- and TgAb+ based on the limit of detection (LoD; ≥0.07 IU/mL), functional sensitivity (FS; ≥0.31 IU/mL), MCO (≥4.11 IU/mL), and ICO (≥10 IU/mL). Results: All patients were TgAb+ based on the LoD; one patient was negative on FS. Fifty-five (23.9%) and 34 (14.8%) patients had TgAbs above the MCO and ICO, respectively. Histology, presence of multifocality, tumor-node-metastasis, and American Thyroid Assocation risk stratification did not differ between TgAb- and TgAb+ patients using MCO and ICO during ablation. Conclusions: This study supports the use of a higher cutoff value than that of the FS for TgAb positivity in clinical settings. The LoD and FS are too sensitive to discriminate TgAb positivity and negativity in DTC patients during ablation therapy. The presence of TgAbs during ablation is not related to tumor characteristics and risk profile. This implies that TgAb positivity should not be considered a separate risk factor.

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UR - https://www.ncbi.nlm.nih.gov/pubmed/30351209

U2 - 10.1089/thy.2018.0195

DO - 10.1089/thy.2018.0195

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EP - 78

JO - Thyroid

JF - Thyroid

SN - 1050-7256

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