Fully Automated Immunoassay Determines Autoantibodies to TSH Receptor

A fully automated immunoassay has been launched for the determination of autoantibodies to the thyroid-stimulating hormone (TSH) receptor for the differential diagnosis of Graves' disease. The newly developed assay has been shown to meet diagnostic requirements with excellent sensitivity and specificity. The total test time is 27 minutes, which is significantly faster than existing methods.

Graves` disease, which is also known as Basedow's disease, is the main type of autoimmune thyroid disease and is associated with hyperthyroidism and ophthalmopathy. The incidence is about 40 cases per 100,000 population per year. The TSH receptor antibody (TRAb) is the major pathogenic factor in Graves' disease, which, like TSH, binds the receptor and has a stimulatory effect with resulting hyperthyroidism. Measurement of the TSH receptor antibody is recommended in the diagnosis of Graves' disease and differentiation from diffuse thyroid autonomy. TRAb measurement is also used for monitoring antithyroid drug treatment.

The assay has been Conformité Européenne (CE)-approved for use on the Roche Diagnostics (Rotkreuz, Switzerland) Elecsys/cobase electrochemiluminescence immunoassay systems. The Elecsys TSH receptor antibody assay is based on intellectual property owned by RSR Ltd. (Cardiff, UK), a company with which Roche has a license agreement.

The anti-TSHR assay complements Roche Diagnostics' broad immunoassay menu on Elecsys and cobas e platforms, which permit the use of both routine and special assays.

"The new TRAb assay provides the opportunity to perform differential diagnosis of thyroid autoimmune diseases with new levels of accuracy, speed, and degree of automation,” said Dirk Ehlers, head of Roche Diagnostics. "This assay will further strengthen Roche's comprehensive test menu in thyroid diseases and endocrinology.”


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