Siemens has launched an automated quantitative thyroid stimulating immunoglobulin (TSI) assay designed for use in the differential diagnosis of Graves’ disease, an autoimmune disorder.
Introduced by Siemens Healthcare Laboratory Diagnostics, the new assay is available on the Siemens Immulite 2000 and Immulite 2000 XPi immunoassay systems.
The TSI assay detects only thyroid stimulating antibodies in Graves’ disease, while TRAb (TSH receptor antibody) assays detect both stimulating and blocking antibodies
The assay, which has a clinical sensitivity and specificity of 98.3% and 99.7% respectively, provides laboratories with a fast, easy, and specific diagnostic tool to evaluate Graves’ disease, which is the most common form of hyperthyroidism.
Graves’ disease is characterised by the presence of TSI, which are found in more than 90% of patients. The company noted that TSI mimic the activity of TSH, leading to an elevated production of thyroid hormone.
Siemens Healthcare Laboratory Diagnostics business area president Franz Walt said: "Siemens is very proud to offer the first automated quantitative TSI assay on the market.
"This innovation eliminates the need for manual preparations and long incubation times.
"Not only does this automated assay streamline lab operations and enhance efficiency, it also delivers results to clinicians much more quickly enabling faster patient diagnosis and initiation of proper treatment."
If left untreated, Graves’ disease can lead to miscarriage, birth defects, thyroid eye disease and can even be life-threatening.
In order to develop this TSI assay, Siemens has licensed the intellectual property of KreLo Medical Diagnostics.