Search
Graves’ disease: The diagnostic dilemma
Graves' disease, an autoimmune disorder that leads to hyperthyroidism, often presents a significant diagnostic dilemma due to its overlapping symptoms with other thyroid disorders and systemic conditions. Symptoms such as weight loss, anxiety, tremors, and palpitations can easily be mistaken for other medical issues such as anxiety disorders or other types of thyroid dysfunctions. Further complicating the diagnosis is the variability in clinical presentation.
Accurate diagnosis typically requires a combination of clinical evaluation, serological tests for thyroid-stimulating immunoglobulins, and imaging studies such as thyroid ultrasounds or radioactive iodine uptake tests. However, the challenge lies in timely and accurately distinguishing Graves' disease from other potential diagnoses to initiate appropriate treatment and manage the disease effectively.
Assay of thyroid stimulating hormone (TSH) receptor antibody concentration
The measurement of the TSH receptor antibody (TRAK) concentration is key to detecting and adequately treating Graves’ disease. Elevated levels of TRAK are highly indicative of Graves’ disease due to the ability of these autoantibodies to stimulate excess thyroid hormone production. The presence and concentration of TRAK can also help differentiate Graves’ disease from other forms of hyperthyroidism, such as toxic multinodular goiter or subacute thyroiditis, where these antibodies are typically absent.
By incorporating TRAK concentration assays into their diagnostic processes, healthcare providers can achieve a more definitive and timely diagnosis, thereby facilitating the initiation of targeted treatments and improving patient outcomes.
With the introduction of the highly sensitive Thermo Scientific B·R·A·H·M·S TRAK human KRYPTOR Assay, definite improvement for differential diagnosis of Graves' disease can be achieved. This assay, which uses immobilized recombinant human TSH receptors, helps to ensure that a greater number of patients can be adequately treated at an early stage and that treatment success can be controlled.
Discover the proven standard: B·R·A·H·M·S TRAK human as a tool of choice for your clinical practice and lab
B·R·A·H·M·S TRAK human KRYPTOR Assay helps to provide the most reliable results for management of Graves’ disease patients. The broad measuring range and dilution availability allows therapy monitoring of all patients independent of TRAb concentration, and therapy efficacy can be addressed even at concentrations above the direct measuring range. Furthermore, apart from the regular diagnostic cut-off, a prognosis cut-off for therapy outcome has been established as well as a cut-off for prognosis of Graves’ orbitopathy.
The TSH receptor antibody assay for improved patient management
The design of B·R·A·H·M·S TRAK human assay is based on human TSH receptors expressed in a leukemia cell line. Therefore, the material is analogous to the TSH receptor in the human thyroid gland. The use of human TSH receptors in the B·R·A·H·M·S TRAK human assay provides superior clinical sensitivity (up to 98.8%) and specificity (up to 99.6%) for the diagnosis of Graves’ disease.1,2
Predict a relapse of Graves’ disease
During management of Graves’ disease (GD) patients, an early assessment of the relapse risk is an important factor for clinicians in treatment decision. For Graves’ patients the information on the chance of a relapse may reduce psychological burden.3
The GREAT score (GREAT = Graves Recurrent Events After Therapy) offers a valuable tool for this assessment. For the GREAT score, a patient’s TRAK (or TBII) value together with 3 other variables (age, goiter size, Free T4 level) at the time of GD diagnosis are used to calculate a six-point score which allows classification into 3 risk classes.4
B·R·A·H·M·S TRAK human KRYPTOR allows outstanding improvement of prognostic value within the GREAT score and can improve prognosis also for risk class III patients, where other methods do not offer any benefit.5
Kaplan-Meyer curves indicating probability of remission over time derived from GREAT score with B·R·A·H·M·S TRAK human KRYPTOR and competitor. No additional data for risk class III patients could be generated with any of the competitor assays in this study.
B·R·A·H·M·S TRAK human KRYPTOR is a tool of choice for clinical assessment of Graves’ disease, enabling optimal treatment decisions.
Graves’ disease or gestational hyperthyroidism?
In pregnant women, TSH-receptor antibody evaluation is crucial to distinguish between hyperthyroidism caused by GD and gestational hyperthyroidism in early pregnancy. A separate assessment of this group of patients is specifically important as the pregnancy related immune suppression affects expected values for autoantibody measurements.6
- B·R·A·H·M·S TRAK human KRYPTOR can distinguish GD and gestational hyperthyroidism in this population at an assay specific cut-off of 1.0 IU/L.7
- B·R·A·H·M·S TRAK human KRYPTOR results in early pregnancy can indicate developing hyperthyroidism later over the course of pregnancy.7
- B·R·A·H·M·S TRAK human KRYPTOR offers comparable performance to the complex and expensive TSI bioassays.8
High discrimination in differential diagnosis
The distribution of TSHR-Ab concentrations in different patient groups demonstrates the high discriminative power of the B·R·A·H·M·S TRAK human assay in various indications.1
Learn more about B·R·A·H·M·S TRAK human in Graves' disease
Brochure: Improving differential diagnosis and follow-up in Graves’ disease
References
- Costagliola, S., et al., Second generation assay for thyrotropin receptor antibodies has superior diagnostic sensitivity for Graves‘ disease. J Clin Endocrinol Metab, 1999. 84(1): p. 90-7.
- Carella, C., et al., Serum thyrotropin receptor antibodies concentrations in patients with Graves‘ disease before, at the end of methimazole treatment, and after drug withdrawal: evidence that the activity of thyrotropin receptor antibody and/or thyroid response modify during the observation period. Thyroid, 2006. 16(3): p. 295-302.
- Jansen, H.I., et al., J Endocrinol Invest, 2024. 47(10): 2499-2505.
- Struja, T., et al., Eur J Endocrinol, 2017. 176(4): 413-419.
- Struja, T., et al., BMC Endocr Disord, 2019. 19(1): 38.
- Weetman, A.P., Thyroid, 1999. 9(7): 643-646.
- Uldall-Torp, N.M., et al., J Clin Endocrinol Metab, 2022. 107(9): e3705-e3713.
Thermo Fisher Scientific products are distributed globally and their uses, applications, indications, claims and availability of products in each country depend on local regulatory marketing authorization status, please consult the Instructions For Use (IFU) available in your country.
© 2026 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. B·R·A·H·M·S is a registered trademark of B·R·A·H·M·S GmbH.
KRYPTOR and TRACE are trademarks of Cisbio Bioassays, licensed for use by B·R·A·H·M·S GmbH, a part of Thermo Fisher Scientific. Nobel Prize is a registered trademark of the Nobel Foundation.