IMMULITE 2000/2000 XPi TSI Assay
Graves’ disease (GD) is an autoimmune disorder caused by the presence of thyroid stimulating immunoglobulins (TSI) that bind to the TSH receptor on the thyroid cells and stimulate the uncontrolled production of thyroid hormones. Detecting the presence of TSI in the blood is a powerful diagnostic tool for the differential diagnosis of GD.
TSI measurements are also used to monitor the response to GD therapy and prediction of remission or relapse, confirming Graves’ ophthalmopathy, and for predicting neonatal thyroid hyperthyroidism.1,2 Incorporating the TSI assay into existing diagnostic algorithms has been shown to reduce overall direct costs of GD diagnosis by up to 43%, with the net cost of avoiding misdiagnosis reduced by up to 85%.3
The IMMULITE® 2000/2000 XPi TSI assay is the first automated and quantitative TSI assay available today. TSH receptor antibody (TRAb) assays detect both thyroid blocking and stimulating antibodies. However, blocking antibodies inhibit TSH stimulation of thyroid cells and lead to hypothyroidism. The IMMULITE 2000/2000 XPi TSI assay detects thyroid stimulating antibodies, the specific cause of GD pathology, with a clinical sensitivity and specificity of 98.6% and 98.5% respectively. With a 65-minute total assay time and ready-to-use, stable reagents, the use of this assay can make the differential diagnosis of GD faster and easier, allowing patients to be diagnosed and treated sooner.
1Gupta, Manjula K. Thyrotropin-receptor antibodies in thyroid diseases: advances in detection techniques and clinical applications. Clinica Chimica Acta. 2000;293:1-29
2M.R. Bjorgaas, H. Farstad, S.C. Christiansen, H-G.K. Blaas. Impact of thyrotrophin receptor antibody levels on fetal development in two successive pregnancies in a woman with Graves’ disease. Horm, res. Paediatr. 79:39-43, 2012.
3McKee A., Peyerl, F. TSI assay utilization: impact on costs of Graves’ hyperthyroidism diagnosis. AJMC. 2012; 18(1):1-15.
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