Elecsys® Anti-TSHR

Complex testing, simplified and automated

  • Hyperthyroidism in Graves` disease (autoimmune hyperthyroidism) is caused by antibodies to the TSH receptor.
  • The TSH receptor antibody test, Elecsys Anti-TSHR, is used for the detection or exclusion of Graves` disease and differentiation from disseminated autonomy of the thyroid gland.
  • The test is used for therapy monitoring of Grave`s disease and prediction of relapse.
  • Another indication is the risk assessment of developing fetal hyperthyroidism in the last trimester of pregnancy.
anti-TSHR

The functional sensitivity of Elecsys Anti-TSHR at approx. 0.9 IU/L is significantly below the cut-off (≥1.75 IU/L), allowing clear differentiation of pathological results.

Assay time 27 min
Sample material Serum
Sample volume 50 uL
Measuring range 0.3 - 40 IU/L
Detection Limit* LoB 0.3 pg/mL, LoD 0.5 pg/mL, LoQ 1 pg/mL

*LoB = Limit of blanks; LoD = Limit of detection; LoQ = Limit of quantitation(<30 % total error)

Improved efficiency

  • Fully automated test for more workflow efficiency, allows for consolidation of tests required for differential diagnosis of thyroid diseases
  • Rapid availability of Anti-TSHR results supports cost- and time-efficient differential diagnosis of thyroid diseases and early treatment

High quality results

  • Advanced assay quality based on proven and leading ECL technology
  • Excellent precision across the entire measuring range
  • High diagnostic value based on high sensitivity paired with high specificity

Availability of a fast and automatic TRAb assay offers an attractive alternative to the manual TRAb assays for the differential diagnosis of hyperthyroidism.
Gassner et al. First automated assay for thyrotropin receptor autoantibodies, Clin Chem Lab Med 2009;47:1091–5.

In spite of the short measuring time of only 27 minutes, the assay showed the same or better results with the existing commercial products. The short measuring time would contribute to speedy, preconsultation diagnosis of thyroid disease, especially of Graves’ disease.
Noh et al. Evaluation of a New Rapid and Fully Automated Electrochemiluminescence Immunoassay for Thyrotropin Receptor Autoantibodies.

Results clearly show that this first automated assay system for the measurement of TSH receptor autoantibodies has a high sensitivity for detecting GD and a high specificity for discriminating from other thyroid diseases as described from other highly sensitive manual TRAb assays. Moreover, this assay is less time consuming and needs less man power than manual TRAb assays and may therefore represent the future technology for TRAb detection in clinical practice.Our results demonstrate that this new assay system has a high sensitivity for detecting GD and specificity for discriminating from other thyroid diseases. This assay may represent the future technology for rapid fully automated TRAb detection.
Schott et al. Clinical value of the first automated TSH receptor autoantibody assay for the diagnosis of Graves’ disease (GD): an international multicentre trial. Clinical Endocrinology (2009) 71, 566–573