Accuracy of receptor-based methods for detection of thyrotropin-receptor autoantibodies: a new automated third-generation immunoassay shows higher analytical and clinical sensitivity for the differential diagnosis of hyperthyroidism

Purpose Specific autoantibodies acting as TSH receptor agonists (TRAb) are responsible for Graves’ disease (GD). In the last 30 years three generations of assay methods for the detection of TRAb have become available. The aim of this multicentre study was to evaluate the analytical sensitivity, prec...
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Autor*in:	Tozzoli, Renato [verfasserIn] Kodermaz, Graziano Villalta, Danilo Bagnasco, Marcello Pesce, Giampaola Bizzaro, Nicola

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2010

Schlagwörter:	TSHR antibodies Automated TRAb immunoassay Graves’ disease Hyperthyroidism Sensitivity Specificity

Anmerkung:	© Springer-Verlag 2010

Übergeordnetes Werk:	Enthalten in: Autoimmunity highlights - Mailand : Springer Milan, 2010, 1(2010), 2 vom: Nov., Seite 95-100
Übergeordnetes Werk:	volume:1 ; year:2010 ; number:2 ; month:11 ; pages:95-100

Links:	Volltext

DOI / URN:	10.1007/s13317-010-0014-4

Katalog-ID:	SPR031317367

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520			\|a Purpose Specific autoantibodies acting as TSH receptor agonists (TRAb) are responsible for Graves’ disease (GD). In the last 30 years three generations of assay methods for the detection of TRAb have become available. The aim of this multicentre study was to evaluate the analytical sensitivity, precision and diagnostic accuracy of TRAb measurement using a new automated assay in comparison with a second-generation standard method. Methods Serum samples from patients with GD (n=82), autoimmune thyroiditis (AIT, n=57) or hyperthyroidism (HT, n=292), from 106 healthy subjects and from 57 patients with infectious diseases were analysed using a third-generation TRAb immunoassay (anti-TSHR, RAD 120; Radim, Italy) based on the human monoclonal TSH receptor antibody M22. Results Using a cut-off value of 1.25 mIU/l, established by ROC curve analysis, 80/82 GD patients (97.5%), 68/292 HT patients (23.2%), and 6/57 AIT patients (10.5%) were TRAb-positive with the M22-based automated assay. The percentages of TRAb positivity were lower in the same patients when the measurements were done with the second-generation method (95.1%, 18.9%, 7.0%, respectively). Conclusion The M22-based automated immunoassay shows high functional sensitivity (0.4 mIU/l) and high diagnostic specificity, is more sensitive than the standard second-generation method and is less time-consuming and labourintensive, and is therefore the up-to-date technology for TRAb detection in clinical practice.
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700	1		\|a Bizzaro, Nicola \|4 aut
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allfields	10.1007/s13317-010-0014-4 doi (DE-627)SPR031317367 (SPR)s13317-010-0014-4-e DE-627 ger DE-627 rakwb eng Tozzoli, Renato verfasserin aut Accuracy of receptor-based methods for detection of thyrotropin-receptor autoantibodies: a new automated third-generation immunoassay shows higher analytical and clinical sensitivity for the differential diagnosis of hyperthyroidism 2010 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer-Verlag 2010 Purpose Specific autoantibodies acting as TSH receptor agonists (TRAb) are responsible for Graves’ disease (GD). In the last 30 years three generations of assay methods for the detection of TRAb have become available. The aim of this multicentre study was to evaluate the analytical sensitivity, precision and diagnostic accuracy of TRAb measurement using a new automated assay in comparison with a second-generation standard method. Methods Serum samples from patients with GD (n=82), autoimmune thyroiditis (AIT, n=57) or hyperthyroidism (HT, n=292), from 106 healthy subjects and from 57 patients with infectious diseases were analysed using a third-generation TRAb immunoassay (anti-TSHR, RAD 120; Radim, Italy) based on the human monoclonal TSH receptor antibody M22. Results Using a cut-off value of 1.25 mIU/l, established by ROC curve analysis, 80/82 GD patients (97.5%), 68/292 HT patients (23.2%), and 6/57 AIT patients (10.5%) were TRAb-positive with the M22-based automated assay. The percentages of TRAb positivity were lower in the same patients when the measurements were done with the second-generation method (95.1%, 18.9%, 7.0%, respectively). Conclusion The M22-based automated immunoassay shows high functional sensitivity (0.4 mIU/l) and high diagnostic specificity, is more sensitive than the standard second-generation method and is less time-consuming and labourintensive, and is therefore the up-to-date technology for TRAb detection in clinical practice. TSHR antibodies (dpeaa)DE-He213 Automated TRAb immunoassay (dpeaa)DE-He213 Graves’ disease (dpeaa)DE-He213 Hyperthyroidism (dpeaa)DE-He213 Sensitivity (dpeaa)DE-He213 Specificity (dpeaa)DE-He213 Kodermaz, Graziano aut Villalta, Danilo aut Bagnasco, Marcello aut Pesce, Giampaola aut Bizzaro, Nicola aut Enthalten in Autoimmunity highlights Mailand : Springer Milan, 2010 1(2010), 2 vom: Nov., Seite 95-100 (DE-627)631492992 (DE-600)2563376-4 2038-3274 nnns volume:1 year:2010 number:2 month:11 pages:95-100 https://dx.doi.org/10.1007/s13317-010-0014-4 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2005 GBV_ILN_2014 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 1 2010 2 11 95-100
spelling	10.1007/s13317-010-0014-4 doi (DE-627)SPR031317367 (SPR)s13317-010-0014-4-e DE-627 ger DE-627 rakwb eng Tozzoli, Renato verfasserin aut Accuracy of receptor-based methods for detection of thyrotropin-receptor autoantibodies: a new automated third-generation immunoassay shows higher analytical and clinical sensitivity for the differential diagnosis of hyperthyroidism 2010 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer-Verlag 2010 Purpose Specific autoantibodies acting as TSH receptor agonists (TRAb) are responsible for Graves’ disease (GD). In the last 30 years three generations of assay methods for the detection of TRAb have become available. The aim of this multicentre study was to evaluate the analytical sensitivity, precision and diagnostic accuracy of TRAb measurement using a new automated assay in comparison with a second-generation standard method. Methods Serum samples from patients with GD (n=82), autoimmune thyroiditis (AIT, n=57) or hyperthyroidism (HT, n=292), from 106 healthy subjects and from 57 patients with infectious diseases were analysed using a third-generation TRAb immunoassay (anti-TSHR, RAD 120; Radim, Italy) based on the human monoclonal TSH receptor antibody M22. Results Using a cut-off value of 1.25 mIU/l, established by ROC curve analysis, 80/82 GD patients (97.5%), 68/292 HT patients (23.2%), and 6/57 AIT patients (10.5%) were TRAb-positive with the M22-based automated assay. The percentages of TRAb positivity were lower in the same patients when the measurements were done with the second-generation method (95.1%, 18.9%, 7.0%, respectively). Conclusion The M22-based automated immunoassay shows high functional sensitivity (0.4 mIU/l) and high diagnostic specificity, is more sensitive than the standard second-generation method and is less time-consuming and labourintensive, and is therefore the up-to-date technology for TRAb detection in clinical practice. TSHR antibodies (dpeaa)DE-He213 Automated TRAb immunoassay (dpeaa)DE-He213 Graves’ disease (dpeaa)DE-He213 Hyperthyroidism (dpeaa)DE-He213 Sensitivity (dpeaa)DE-He213 Specificity (dpeaa)DE-He213 Kodermaz, Graziano aut Villalta, Danilo aut Bagnasco, Marcello aut Pesce, Giampaola aut Bizzaro, Nicola aut Enthalten in Autoimmunity highlights Mailand : Springer Milan, 2010 1(2010), 2 vom: Nov., Seite 95-100 (DE-627)631492992 (DE-600)2563376-4 2038-3274 nnns volume:1 year:2010 number:2 month:11 pages:95-100 https://dx.doi.org/10.1007/s13317-010-0014-4 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2005 GBV_ILN_2014 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 1 2010 2 11 95-100
allfields_unstemmed	10.1007/s13317-010-0014-4 doi (DE-627)SPR031317367 (SPR)s13317-010-0014-4-e DE-627 ger DE-627 rakwb eng Tozzoli, Renato verfasserin aut Accuracy of receptor-based methods for detection of thyrotropin-receptor autoantibodies: a new automated third-generation immunoassay shows higher analytical and clinical sensitivity for the differential diagnosis of hyperthyroidism 2010 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer-Verlag 2010 Purpose Specific autoantibodies acting as TSH receptor agonists (TRAb) are responsible for Graves’ disease (GD). In the last 30 years three generations of assay methods for the detection of TRAb have become available. The aim of this multicentre study was to evaluate the analytical sensitivity, precision and diagnostic accuracy of TRAb measurement using a new automated assay in comparison with a second-generation standard method. Methods Serum samples from patients with GD (n=82), autoimmune thyroiditis (AIT, n=57) or hyperthyroidism (HT, n=292), from 106 healthy subjects and from 57 patients with infectious diseases were analysed using a third-generation TRAb immunoassay (anti-TSHR, RAD 120; Radim, Italy) based on the human monoclonal TSH receptor antibody M22. Results Using a cut-off value of 1.25 mIU/l, established by ROC curve analysis, 80/82 GD patients (97.5%), 68/292 HT patients (23.2%), and 6/57 AIT patients (10.5%) were TRAb-positive with the M22-based automated assay. The percentages of TRAb positivity were lower in the same patients when the measurements were done with the second-generation method (95.1%, 18.9%, 7.0%, respectively). Conclusion The M22-based automated immunoassay shows high functional sensitivity (0.4 mIU/l) and high diagnostic specificity, is more sensitive than the standard second-generation method and is less time-consuming and labourintensive, and is therefore the up-to-date technology for TRAb detection in clinical practice. TSHR antibodies (dpeaa)DE-He213 Automated TRAb immunoassay (dpeaa)DE-He213 Graves’ disease (dpeaa)DE-He213 Hyperthyroidism (dpeaa)DE-He213 Sensitivity (dpeaa)DE-He213 Specificity (dpeaa)DE-He213 Kodermaz, Graziano aut Villalta, Danilo aut Bagnasco, Marcello aut Pesce, Giampaola aut Bizzaro, Nicola aut Enthalten in Autoimmunity highlights Mailand : Springer Milan, 2010 1(2010), 2 vom: Nov., Seite 95-100 (DE-627)631492992 (DE-600)2563376-4 2038-3274 nnns volume:1 year:2010 number:2 month:11 pages:95-100 https://dx.doi.org/10.1007/s13317-010-0014-4 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2005 GBV_ILN_2014 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 1 2010 2 11 95-100
allfieldsGer	10.1007/s13317-010-0014-4 doi (DE-627)SPR031317367 (SPR)s13317-010-0014-4-e DE-627 ger DE-627 rakwb eng Tozzoli, Renato verfasserin aut Accuracy of receptor-based methods for detection of thyrotropin-receptor autoantibodies: a new automated third-generation immunoassay shows higher analytical and clinical sensitivity for the differential diagnosis of hyperthyroidism 2010 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer-Verlag 2010 Purpose Specific autoantibodies acting as TSH receptor agonists (TRAb) are responsible for Graves’ disease (GD). In the last 30 years three generations of assay methods for the detection of TRAb have become available. The aim of this multicentre study was to evaluate the analytical sensitivity, precision and diagnostic accuracy of TRAb measurement using a new automated assay in comparison with a second-generation standard method. Methods Serum samples from patients with GD (n=82), autoimmune thyroiditis (AIT, n=57) or hyperthyroidism (HT, n=292), from 106 healthy subjects and from 57 patients with infectious diseases were analysed using a third-generation TRAb immunoassay (anti-TSHR, RAD 120; Radim, Italy) based on the human monoclonal TSH receptor antibody M22. Results Using a cut-off value of 1.25 mIU/l, established by ROC curve analysis, 80/82 GD patients (97.5%), 68/292 HT patients (23.2%), and 6/57 AIT patients (10.5%) were TRAb-positive with the M22-based automated assay. The percentages of TRAb positivity were lower in the same patients when the measurements were done with the second-generation method (95.1%, 18.9%, 7.0%, respectively). Conclusion The M22-based automated immunoassay shows high functional sensitivity (0.4 mIU/l) and high diagnostic specificity, is more sensitive than the standard second-generation method and is less time-consuming and labourintensive, and is therefore the up-to-date technology for TRAb detection in clinical practice. TSHR antibodies (dpeaa)DE-He213 Automated TRAb immunoassay (dpeaa)DE-He213 Graves’ disease (dpeaa)DE-He213 Hyperthyroidism (dpeaa)DE-He213 Sensitivity (dpeaa)DE-He213 Specificity (dpeaa)DE-He213 Kodermaz, Graziano aut Villalta, Danilo aut Bagnasco, Marcello aut Pesce, Giampaola aut Bizzaro, Nicola aut Enthalten in Autoimmunity highlights Mailand : Springer Milan, 2010 1(2010), 2 vom: Nov., Seite 95-100 (DE-627)631492992 (DE-600)2563376-4 2038-3274 nnns volume:1 year:2010 number:2 month:11 pages:95-100 https://dx.doi.org/10.1007/s13317-010-0014-4 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2005 GBV_ILN_2014 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 1 2010 2 11 95-100
allfieldsSound	10.1007/s13317-010-0014-4 doi (DE-627)SPR031317367 (SPR)s13317-010-0014-4-e DE-627 ger DE-627 rakwb eng Tozzoli, Renato verfasserin aut Accuracy of receptor-based methods for detection of thyrotropin-receptor autoantibodies: a new automated third-generation immunoassay shows higher analytical and clinical sensitivity for the differential diagnosis of hyperthyroidism 2010 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer-Verlag 2010 Purpose Specific autoantibodies acting as TSH receptor agonists (TRAb) are responsible for Graves’ disease (GD). In the last 30 years three generations of assay methods for the detection of TRAb have become available. The aim of this multicentre study was to evaluate the analytical sensitivity, precision and diagnostic accuracy of TRAb measurement using a new automated assay in comparison with a second-generation standard method. Methods Serum samples from patients with GD (n=82), autoimmune thyroiditis (AIT, n=57) or hyperthyroidism (HT, n=292), from 106 healthy subjects and from 57 patients with infectious diseases were analysed using a third-generation TRAb immunoassay (anti-TSHR, RAD 120; Radim, Italy) based on the human monoclonal TSH receptor antibody M22. Results Using a cut-off value of 1.25 mIU/l, established by ROC curve analysis, 80/82 GD patients (97.5%), 68/292 HT patients (23.2%), and 6/57 AIT patients (10.5%) were TRAb-positive with the M22-based automated assay. The percentages of TRAb positivity were lower in the same patients when the measurements were done with the second-generation method (95.1%, 18.9%, 7.0%, respectively). Conclusion The M22-based automated immunoassay shows high functional sensitivity (0.4 mIU/l) and high diagnostic specificity, is more sensitive than the standard second-generation method and is less time-consuming and labourintensive, and is therefore the up-to-date technology for TRAb detection in clinical practice. TSHR antibodies (dpeaa)DE-He213 Automated TRAb immunoassay (dpeaa)DE-He213 Graves’ disease (dpeaa)DE-He213 Hyperthyroidism (dpeaa)DE-He213 Sensitivity (dpeaa)DE-He213 Specificity (dpeaa)DE-He213 Kodermaz, Graziano aut Villalta, Danilo aut Bagnasco, Marcello aut Pesce, Giampaola aut Bizzaro, Nicola aut Enthalten in Autoimmunity highlights Mailand : Springer Milan, 2010 1(2010), 2 vom: Nov., Seite 95-100 (DE-627)631492992 (DE-600)2563376-4 2038-3274 nnns volume:1 year:2010 number:2 month:11 pages:95-100 https://dx.doi.org/10.1007/s13317-010-0014-4 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2005 GBV_ILN_2014 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 1 2010 2 11 95-100
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source	Enthalten in Autoimmunity highlights 1(2010), 2 vom: Nov., Seite 95-100 volume:1 year:2010 number:2 month:11 pages:95-100
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In the last 30 years three generations of assay methods for the detection of TRAb have become available. The aim of this multicentre study was to evaluate the analytical sensitivity, precision and diagnostic accuracy of TRAb measurement using a new automated assay in comparison with a second-generation standard method. Methods Serum samples from patients with GD (n=82), autoimmune thyroiditis (AIT, n=57) or hyperthyroidism (HT, n=292), from 106 healthy subjects and from 57 patients with infectious diseases were analysed using a third-generation TRAb immunoassay (anti-TSHR, RAD 120; Radim, Italy) based on the human monoclonal TSH receptor antibody M22. Results Using a cut-off value of 1.25 mIU/l, established by ROC curve analysis, 80/82 GD patients (97.5%), 68/292 HT patients (23.2%), and 6/57 AIT patients (10.5%) were TRAb-positive with the M22-based automated assay. The percentages of TRAb positivity were lower in the same patients when the measurements were done with the second-generation method (95.1%, 18.9%, 7.0%, respectively). 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author	Tozzoli, Renato
spellingShingle	Tozzoli, Renato misc TSHR antibodies misc Automated TRAb immunoassay misc Graves’ disease misc Hyperthyroidism misc Sensitivity misc Specificity Accuracy of receptor-based methods for detection of thyrotropin-receptor autoantibodies: a new automated third-generation immunoassay shows higher analytical and clinical sensitivity for the differential diagnosis of hyperthyroidism
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topic_title	Accuracy of receptor-based methods for detection of thyrotropin-receptor autoantibodies: a new automated third-generation immunoassay shows higher analytical and clinical sensitivity for the differential diagnosis of hyperthyroidism TSHR antibodies (dpeaa)DE-He213 Automated TRAb immunoassay (dpeaa)DE-He213 Graves’ disease (dpeaa)DE-He213 Hyperthyroidism (dpeaa)DE-He213 Sensitivity (dpeaa)DE-He213 Specificity (dpeaa)DE-He213
topic	misc TSHR antibodies misc Automated TRAb immunoassay misc Graves’ disease misc Hyperthyroidism misc Sensitivity misc Specificity
topic_unstemmed	misc TSHR antibodies misc Automated TRAb immunoassay misc Graves’ disease misc Hyperthyroidism misc Sensitivity misc Specificity
topic_browse	misc TSHR antibodies misc Automated TRAb immunoassay misc Graves’ disease misc Hyperthyroidism misc Sensitivity misc Specificity
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title	Accuracy of receptor-based methods for detection of thyrotropin-receptor autoantibodies: a new automated third-generation immunoassay shows higher analytical and clinical sensitivity for the differential diagnosis of hyperthyroidism
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title_full	Accuracy of receptor-based methods for detection of thyrotropin-receptor autoantibodies: a new automated third-generation immunoassay shows higher analytical and clinical sensitivity for the differential diagnosis of hyperthyroidism
author_sort	Tozzoli, Renato
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author_browse	Tozzoli, Renato Kodermaz, Graziano Villalta, Danilo Bagnasco, Marcello Pesce, Giampaola Bizzaro, Nicola
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title_sort	accuracy of receptor-based methods for detection of thyrotropin-receptor autoantibodies: a new automated third-generation immunoassay shows higher analytical and clinical sensitivity for the differential diagnosis of hyperthyroidism
title_auth	Accuracy of receptor-based methods for detection of thyrotropin-receptor autoantibodies: a new automated third-generation immunoassay shows higher analytical and clinical sensitivity for the differential diagnosis of hyperthyroidism
abstract	Purpose Specific autoantibodies acting as TSH receptor agonists (TRAb) are responsible for Graves’ disease (GD). In the last 30 years three generations of assay methods for the detection of TRAb have become available. The aim of this multicentre study was to evaluate the analytical sensitivity, precision and diagnostic accuracy of TRAb measurement using a new automated assay in comparison with a second-generation standard method. Methods Serum samples from patients with GD (n=82), autoimmune thyroiditis (AIT, n=57) or hyperthyroidism (HT, n=292), from 106 healthy subjects and from 57 patients with infectious diseases were analysed using a third-generation TRAb immunoassay (anti-TSHR, RAD 120; Radim, Italy) based on the human monoclonal TSH receptor antibody M22. Results Using a cut-off value of 1.25 mIU/l, established by ROC curve analysis, 80/82 GD patients (97.5%), 68/292 HT patients (23.2%), and 6/57 AIT patients (10.5%) were TRAb-positive with the M22-based automated assay. The percentages of TRAb positivity were lower in the same patients when the measurements were done with the second-generation method (95.1%, 18.9%, 7.0%, respectively). Conclusion The M22-based automated immunoassay shows high functional sensitivity (0.4 mIU/l) and high diagnostic specificity, is more sensitive than the standard second-generation method and is less time-consuming and labourintensive, and is therefore the up-to-date technology for TRAb detection in clinical practice. © Springer-Verlag 2010
abstractGer	Purpose Specific autoantibodies acting as TSH receptor agonists (TRAb) are responsible for Graves’ disease (GD). In the last 30 years three generations of assay methods for the detection of TRAb have become available. The aim of this multicentre study was to evaluate the analytical sensitivity, precision and diagnostic accuracy of TRAb measurement using a new automated assay in comparison with a second-generation standard method. Methods Serum samples from patients with GD (n=82), autoimmune thyroiditis (AIT, n=57) or hyperthyroidism (HT, n=292), from 106 healthy subjects and from 57 patients with infectious diseases were analysed using a third-generation TRAb immunoassay (anti-TSHR, RAD 120; Radim, Italy) based on the human monoclonal TSH receptor antibody M22. Results Using a cut-off value of 1.25 mIU/l, established by ROC curve analysis, 80/82 GD patients (97.5%), 68/292 HT patients (23.2%), and 6/57 AIT patients (10.5%) were TRAb-positive with the M22-based automated assay. The percentages of TRAb positivity were lower in the same patients when the measurements were done with the second-generation method (95.1%, 18.9%, 7.0%, respectively). Conclusion The M22-based automated immunoassay shows high functional sensitivity (0.4 mIU/l) and high diagnostic specificity, is more sensitive than the standard second-generation method and is less time-consuming and labourintensive, and is therefore the up-to-date technology for TRAb detection in clinical practice. © Springer-Verlag 2010
abstract_unstemmed	Purpose Specific autoantibodies acting as TSH receptor agonists (TRAb) are responsible for Graves’ disease (GD). In the last 30 years three generations of assay methods for the detection of TRAb have become available. The aim of this multicentre study was to evaluate the analytical sensitivity, precision and diagnostic accuracy of TRAb measurement using a new automated assay in comparison with a second-generation standard method. Methods Serum samples from patients with GD (n=82), autoimmune thyroiditis (AIT, n=57) or hyperthyroidism (HT, n=292), from 106 healthy subjects and from 57 patients with infectious diseases were analysed using a third-generation TRAb immunoassay (anti-TSHR, RAD 120; Radim, Italy) based on the human monoclonal TSH receptor antibody M22. Results Using a cut-off value of 1.25 mIU/l, established by ROC curve analysis, 80/82 GD patients (97.5%), 68/292 HT patients (23.2%), and 6/57 AIT patients (10.5%) were TRAb-positive with the M22-based automated assay. The percentages of TRAb positivity were lower in the same patients when the measurements were done with the second-generation method (95.1%, 18.9%, 7.0%, respectively). Conclusion The M22-based automated immunoassay shows high functional sensitivity (0.4 mIU/l) and high diagnostic specificity, is more sensitive than the standard second-generation method and is less time-consuming and labourintensive, and is therefore the up-to-date technology for TRAb detection in clinical practice. © Springer-Verlag 2010
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title_short	Accuracy of receptor-based methods for detection of thyrotropin-receptor autoantibodies: a new automated third-generation immunoassay shows higher analytical and clinical sensitivity for the differential diagnosis of hyperthyroidism
url	https://dx.doi.org/10.1007/s13317-010-0014-4
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author2	Kodermaz, Graziano Villalta, Danilo Bagnasco, Marcello Pesce, Giampaola Bizzaro, Nicola
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up_date	2024-07-03T23:08:47.669Z
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The percentages of TRAb positivity were lower in the same patients when the measurements were done with the second-generation method (95.1%, 18.9%, 7.0%, respectively). 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Accuracy of receptor-based methods for detection of thyrotropin-receptor autoantibodies: a new automated third-generation immunoassay shows higher analytical and clinical sensitivity for the differential diagnosis of hyperthyroidism

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