ArticleJournal of clinical laboratory analysis2021
Evaluation of analytic and clinical performance of two immunoassays for detecting thyroid-stimulating receptor antibody in the diagnosis of Graves' disease.
Article in Journal of clinical laboratory analysis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed, 8 citations in OpenAlex.
- Article
- Predictive Performance of 2 Immunoassays in Patients with Graves Disease Undergoing Radioiodine Therapy: Prospective Study.Journal of the Endocrine Society · 2025Article
- Comparison Between Thyroid Stimulating Immunoglobulin and TSH-Receptor Antibodies in the Management of Graves' Orbitopathy.Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association · 2023Article
- Article
- Evaluation of analytic and clinical performance of two immunoassays for detecting thyroid-stimulating receptor antibody in the diagnosis of Graves' disease.Journal of clinical laboratory analysis · 2021Article
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Authors and funding
8 authors at 1 institution in 1 country.
Funding
Abstract
objectiveTo evaluate the analytical and clinical performance of two immunoassays for diagnosis of Graves' disease (GD), the Immulite thyroid-stimulating immunoglobulin (TSI), and Elecsys Anti-TSH receptor (TSHR) assay.
methodsPrecision and analytical measurement range were assessed using pooled samples of patients. The comparison between the two methods was evaluated using 579 clinical samples, and receiver operating characteristic (ROC) curves were drawn using the final diagnosis as reference. Clinical sensitivity and specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) were calculated for the two tests.
resultsThe repeatability and intermediate imprecision coefficient of variation (CV%) of the TSI assay were 3.8% and 4.1% at 0.95 IU/L, and 3.5% and3.6% at 19.5 IU/L, respectively. The assays were linear over a range 0.27-38.5 IU/L. There was a high correlation between the quantitative results of the two methods (correlation coefficient r = 0.930). The cut-off value obtained by ROC analysis for TSI assay was 0.7 IU/L with sensitivity of 93.7% and specificity of 85.1%. An overall qualitative agreement of 91.5% between two methods was observed. Among 44 patients with discordant qualitative results, the TSI assay provided more satisfactory results consistent with clinical diagnoses.
conclusionThe TSI assay showed excellent analytical performance and provided a high PPV for GD.
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