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

Tozzoli, Renato; Kodermaz, Graziano; Villalta, Danilo; Bagnasco, Marcello; Bizzaro, Nicola

doi:10.1007/s13317-010-0014-4

Cited by 19 publications

(16 citation statements)

References 36 publications

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“…Further modifications of the analytical procedures (use of receptors of different species and tissues, different types of preparation of antigenic source, washing procedures, types of tracer, etc.) allowed an improvement of analytical and clinical sensitivity of the second and third generation IMA, ranging from 0.8 IU/L to 1.5 IU/L and 96.4%-97.2%, respectively [14][15][16][17][18][19]. However, although the high clinical specificity, these assays cannot discriminate between the different types of TRAb, present in some patients with different autoimmune thyroid diseases (Table 1).…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the first fully automated immunoassay method for the measurement of stimulating TSH receptor autoantibodies in Graves’ disease

Tozzoli

D’Aurizio

Villalta

et al. 2016

Clinical Chemistry and Laboratory Medicine (CCLM)

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The diagnostic performance of fully automated Immulite TSI assay in GD patients is at least comparable to that of current TRAb immunoassays (IMAs) suggesting the possibility of including such assay in rapid and cost-saving diagnostic and monitoring algorithms. However, our results do not provide full evidence that this assay is specific for S-TRAb only, and future studies comparing Immulite TSI assay to stimulating activity are required.

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Section: Introductionmentioning

confidence: 99%

Evaluation of the first fully automated immunoassay method for the measurement of stimulating TSH receptor autoantibodies in Graves’ disease

Tozzoli

D’Aurizio

Villalta

et al. 2016

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…A prevalence of 9.2% was reported in 54 Singaporean patients with AIT (euthyroid and hypothyroid) which was linked to TSH-R-Ab positivity (5). Positive TSH-R-Ab levels in AIT were also observed when different assays for TSH-R-Ab measurement were validated (10,19,20,28). A recent study reported a 5.5% prevalence of positive thyroid-stimulating antibodies in 700 consecutive and unselected patients with Hashimoto's thyroiditis, while their prevalence was 68.2%…”

Section: Discussionmentioning

confidence: 99%

“…A few of the available studies focused on the hypothesis that blocking TSH-R-Ab might cause thyroid atrophy (3,8). Several studies that included hypothyroid patients showed great variability in the prevalence of elevated TSH-R-Ab, ranging from 5% to 35% (9)(10)(11). While a few surveys about euthyroid patients showed the prevalence rate between 9% and 23% (4,12).…”

Section: Introductionmentioning

confidence: 99%

“…Some publications have described a negative correlation between TSH-R-Ab levels and the thyroid volume (12,(15)(16)(17) or the function (12,15,18), while others did not (9). Most of the older studies used first and second generation thyroid-binding assays (3)(4)(5)19,20), which had lower sensitivity and specificity when compared to the third generation electrochemiluminescence immunoassays (e.g., ECLIA), which are widely available (10,21,22). Only very few studies have demonstrated a comprehensive and complex an7alysis of the clinical, laboratory and ultrasound correlates of TSH-R-Ab levels in AIT.…”

Section: Introductionmentioning

confidence: 99%

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Frequency Profile and Clinical Correlations of TSH Receptor Antibodies in Euthyroid and Hypothyroid Patients Having Autoimmune Thyroiditis

Mekova¹,

Boyanov²

2019

Turk J Endocrinol Metab

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Objective: The current understanding regarding the clinical significance of TSH receptor antibodies in chronic autoimmune thyroiditis is controversial. The aim of this study was to examine the frequency of elevated TSH receptor antibodies in euthyroid and hypothyroid autoimmune thyroiditis. Furthermore, their associations with the levels of thyroid hormones and autoantibodies (thyroid peroxidase and thyroglobulin antibodies [TgAb]), and the thyroid volume were also investigated. Material and Methods: This cross-sectional study included recently diagnosed euthyroid (N=86) and hypothyroid (N=54) autoimmune thyroiditis patients along with the patients who were on levothyroxine replacement (N=66). The levels of TSH, free T4, free T3, TSH receptor antibodies, thyroid peroxidase, and thyroglobulin antibodies were measured using ECLIA (Roche Diagnostics, Switzerland). A 9 MHz transducer (Fukuda Corp., Japan) for thyroid ultrasound and a 14 MHz transducer (Ultrasonix Medical Corp., Canada) for Doppler ultrasound were employed. Statistical analyses were done with the help of IBM SPSS 19.0 software. Results: The elevated levels of TSH receptor antibodies were observed in 6.3% of the participants (12 females and 1 male) and exclusively in hypothyroid subjects, who were either untreated (7.4%) or on levothyroxine treatment (7.6%). The highest and the lowest prevalence of positive TSH receptor antibodies were seen in patients with positive thyroglobulin antibodies & negative thyroid peroxidase (17.6%) and positive thyroid peroxidase & negative thyroglobulin antibodies (3.3%), respectively. Higher levels of TSH receptor antibodies were associated with a shorter duration of the disease (22 vs. 36 months), lower titers of thyroglobulin antibodies (281.2 vs. 400.9 UI/L), decreased thyroid volumes (9.4 vs. 14.2 cm 3) and an increased prevalence of orbitopathy (23.1 vs. 4.1%). In the whole study population, TSH receptor antibodies levels were related to fT4 (linear R2=0.271, p=0.039), titers of thyroid peroxidase (quadratic, R2=0.048, p=0.034), and thyroid volume (compound R2=0.041, p=0.011). However, in the TSH receptor antibodies positive patients, the correlation was seen only with the levels of thyroid peroxidase (compound R2=0.503, p=0.032). Conclusion: TSH receptor antibodies positivity cannot be considered negligible in Hashimoto's thyroiditis. The elevated levels of TSH receptor antibodies might result in a predisposition to a more unstable thyroid function, lower thyroid volumes, specific profiles of thyroid peroxidase, and thyroglobulin antibodies and a higher prevalence of thyroid-associated ophthalmopathy.

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“…Notably, both competitive and non-competitive TRAb assays do not differentiate TBAb from TSAb [22][23][24]. However, TSHR bioassays, the sole assay variants enabling TSAb/TBAb differentiation, have not been introduced into routine laboratories widely yet, although they have proven practical usefulness despite their challenging assay design [25,26].…”

Section: Discussionmentioning

confidence: 99%

A novel third-generation TSH receptor antibody (TRAb) enzyme-linked immunosorbent assay based on a murine monoclonal TSH receptor-binding antibody

et al. 2018

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TSH receptor (TSHR) autoantibody (TRAb) is the serological hallmark of Graves' disease (GD). Third-generation enzyme-linked immunosorbent assays (ELISAs) using monoclonal TRAbs instead of TSH have been found useful for TRAb analysis recently. For the first time, a mouse monoclonal antibody (mAb) against TSHR was analyzed for TRAb detection and compared with human mAb M22 and TSH by the same competitive binding assay technique. A mouse monoclonal antibody (T7) binding to the TSH receptor and inhibiting TSH binding was generated and used for TRAb analysis in a third-generation ELISA. Obtained TRAb levels were compared with a second-generation TRAb assay employing bovine TSH and a third-generation assay with human mAb M22 as TSHR-binding reagents by investigating 89 patients with GD, 56 with Hashimoto's thyroiditis (HT), 73 with non-autoimmune thyroid diseases, 17 with rheumatoid arthritis, and 100 healthy subjects. The T7-based TRAb ELISA did not reveal a significantly different assay performance (area under the curve [AUC]) in contrast to the TSH and M22-based TRAb ELISAs by receiver operating characteristic (ROC) curve analysis (AUC-T7 0.967, AUC-TSH 0.972, AUC-M22 0.958, p > 0.05, respectively). After adjustment of cutoffs by ROC, all three TRAb ELISAs demonstrated sensitivities and specificities above 89.9% and 96.0%, respectively. Both thirdgeneration TRAb ELISAs showed a tendency for a higher prevalence of TRAb positives in HT in contrast to the secondgeneration ELISA. Mouse mAbs against the TSHR may be used for the reliable detection of TRAb by third-generation TRAb ELISA. The earlier reported higher sensitivity of third-generation TRAb ELISA in GD needs to be considered in the context of a slightly lower specificity regarding HT.

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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

Cited by 19 publications

References 36 publications

Evaluation of the first fully automated immunoassay method for the measurement of stimulating TSH receptor autoantibodies in Graves’ disease

Evaluation of the first fully automated immunoassay method for the measurement of stimulating TSH receptor autoantibodies in Graves’ disease

Frequency Profile and Clinical Correlations of TSH Receptor Antibodies in Euthyroid and Hypothyroid Patients Having Autoimmune Thyroiditis

A novel third-generation TSH receptor antibody (TRAb) enzyme-linked immunosorbent assay based on a murine monoclonal TSH receptor-binding antibody

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