Reply to Drs. Kiaei and Molinaro Regarding the Publication
                    “Comparison of a Bridge Immunoassay with Two Bioassays for Thyrotropin Receptor
                    Antibody Detection and Differentiation”

Stephanie Allelein; Tanja Diana; Matthias Schott; George J. Kahaly

doi:10.1055/a-1089-8026

Hormone and Metabolic Research, Inhaltsverzeichnis

CC BY-NC-ND 4.0 · Horm Metab Res 2020; 52(02): 126-127
DOI: 10.1055/a-1089-8026

Letter to the Editor

Reply to Drs. Kiaei and Molinaro Regarding the Publication “Comparison of a Bridge Immunoassay with Two Bioassays for Thyrotropin Receptor Antibody Detection and Differentiation”

Authors

Stephanie Allelein

¹Medical Faculty, Division for Specific Endocrinology, University of Düsseldorf, Düsseldorf , Germany
Tanja Diana

²Department of Medicine I, Molecular Thyroid Research Laboratory, Johannes Gutenberg University (JGU) Medical Center, Mainz , Germany
Matthias Schott

¹Medical Faculty, Division for Specific Endocrinology, University of Düsseldorf, Düsseldorf , Germany
George J. Kahaly

²Department of Medicine I, Molecular Thyroid Research Laboratory, Johannes Gutenberg University (JGU) Medical Center, Mainz , Germany

Abstract

Dear Editor,

Drs. Kiaei and Molinaro [1] put forth two criticisms of the manuscript published by us [2]. They state that the experimental design of this study is flawed and that the authors falsely claim that negative Thyretain™ TSI Reporter BioAssay results for two Graves’ diseases patients undergoing drug treatments means the absence of stimulating antibodies. To substantiate this claim Drs. Kiaei and Molinaro point out that the manufacturer of the Thyretain TSI Reporter BioAssay clearly states in the package insert that “[t]he effects of various drug therapies on the performance of this Kit have not been established” [1]. Second, the package insert explicitly states that “[a] negative result does not exclude the possibility of the presence of TSI” and results of the test should be interpreted in conjunction with information available from other clinical information, such as physical symptoms and thyroid hormone testing, as recommended by the American Thyroid Association (ATA)”. Furthermore they state that the “authors of the manuscript did not consider the manufacturer’s warning regarding the intended patient population and the ATA guidelines regarding the interpretation of the test results in conjunction with other clinical information. Instead, the authors based their conclusions on the negative Thyretain TSI Reporter BioAssay results and ignored the patients’ clinical history of Graves’ disease.”

Volltext

Referenzen

References
1 Kiaei D, Molinaro R. A Negative Thyretain TSI bioassay result does not exclude the possibility of the presence of TSI. Horm Metab Res 2020; 52: 124-125
2 Allelein S, Diana T, Ehlers M. et al. Comparison of a bridge immunoassay with two bioassays for thyrotropin receptor antibody detection and differentiation. Horm Metab Res 2019; 51: 341-346
3 Leschik JJ, Diana T, Olivo PD. et al. Analytical performance and clinical utility of a bioassay for thyroid-stimulating immunoglobulins. Am J Clin Pathol 2013; 139: 192-200
4 Kahaly GJ, Diana T, Glang J. et al. Thyroid stimulating antibodies are highly prevalent in hashimoto̓s thyroiditis and associated orbitopathy. J Clin Endocrinol Metab 2016; 101: 1998-2004
5 Kahaly GJ, Wuster C, Olivo PD. et al. High titers of thyrotropin receptor antibodies are associated with orbitopathy in patients with graves disease. J Clin Endocrinol Metab 2019; 104: 2561-2568
6 Chiovato L, Vitti P, Lombardi A. et al. Detection and characterization of autoantibodies blocking the TSH-dependent cAMP production using FRTL-5 cells. J Endocrinol Invest 1987; 10: 383-388
7 McLachlan SM, Rapoport B. Thyrotropin-blocking autoantibodies and thyroid-stimulating autoantibodies: potential mechanisms involved in the pendulum swinging from hypothyroidism to hyperthyroidism or vice versa. Thyroid 2013; 23: 14-24
8 Li Y, Kim J, Diana T. et al. A novel bioassay for anti-thyrotrophin receptor autoantibodies detects both thyroid-blocking and stimulating activity. Clin Exp Immunol 2013; 173: 390-397
9 Diana T, Li Y, Olivo PD. et al. Analytical performance and validation of a bioassay for thyroid-blocking antibodies. Thyroid 2016; 26: 734-740
10 Diana T, Krause J, Olivo PD. et al. Prevalence and clinical relevance of thyroid stimulating hormone receptor-blocking antibodies in autoimmune thyroid disease. Clin Exp Immunol 2017; 189: 304-309
11 Diana T, Olivo PD, Kahaly GJ. Thyrotropin receptor blocking antibodies. Horm Metab Res 2018; 50: 853-862
12 Diana T, Wuster C, Olivo PD. et al. Performance and specificity of 6 immunoassays for TSH receptor antibodies: a Multicenter Study. Eur Thyroid J 2017; 6: 243-249
13 Lytton SD, Li Y, Olivo PD. et al. Novel chimeric thyroid-stimulating hormone-receptor bioassay for thyroid-stimulating immunoglobulins. Clin Exp Immunol 2010; 162: 438-446
14 Frank CU, Braeth S, Dietrich JW. et al. Bridge technology with TSH receptor chimera for sensitive direct detection of TSH receptor antibodies causing graves’ disease: analytical and clinical evaluation. Horm Metab Res 2015; 47: 880-888
15 Diana T, Wuster C, Kanitz M. et al. Highly variable sensitivity of five binding and two bio-assays for TSH-receptor antibodies. J Endocrinol Invest 2016; 39: 1159-1165