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Introduction and Principle of the Test
The hyperthyroidism of Graves' disease is due to autoantibodies to the thyrotropin (TSH) receptor and measurement of these autoantibodies is valuable in the diagnosis and management of Graves' hyperthyroidism. The enclosed kit provides a simple, sensitive and specific method for measuring TSH receptor autoantibodies (TRAb) in patients' serum samples. In the assay, TSH receptor autoantibodies in patients' sera are allowed to interact with TSH receptor coated onto ELISA plate wells. Bound TRAb are detected by their ability to inhibit the binding of TSH (in the form of TSHbiotin) to the receptor coated wells. The amount of TSH bound is then monitored by addition of streptavidin peroxidase and the peroxidase substrate tetramethyl benzidine. TRAb levels are expressed as an inhibition of TSH binding index or read off a standard curve.
Assay Type : Competitive
Pack Size : 96 wells
Storage : 2-8°C
Clinical Fields : Internal Medicine, Immunology, Endocrinology
Sensitivity : 50 Sera from patients diagnosed with Graves’ disease were assayed using the TSH ELISA kit. 49 (98%) were identified as being positive for TSH Receptor Antibodies. 1 sample (2%) was identified as being within the equivocal range.
Mon - Sat: 10AM - 06PM
Precautions
For in vitro use only.
Some reagents contain sodium azide as preservative (<0.1%). Avoid skin contact.
All reagents of human origin used in this kit are tested for HIV I/II antibodies, HCV and HBsAg and found to be negative. However, because no test method can offer complete assurance that infectious agents are absent, these reagents should be handled as potentially biohazardous materials.
Material of animal origin used in the preparation of the kit have been obtained from certified healthy animals but these materials should be handled as potentially infectious.
Storage and Stability
On arrival, store the kit at 2-8 °C. Once opened the kit is stable until its expiry date. For stability of prepared reagents refer to Preparation of Reagents.
Specimen Collection and Storage
Sera to be analysed should be assayed soon after separation or stored (preferably in aliquots) at or below -20 °C. 0.2 ml is sufficient for one assay. Subsequent freezing and thawing or increase in storage temperature must be avoided. Incorrect storage of serum samples can lead to loss of anti-TSH receptor autoantibodies. Do not use grossly haemolysed or lipaemic serum samples. Do not use plasma in the assay. When required, thaw test sera at room temperature and mix gently to ensure homogeneity. Centrifuge the serum prior to assay (preferably for 5 min at 10-15,000 g in a microfuge) to remove any particulate matter. Please do not omit this centrifugation step.
Limitations
Lipaemic or grossly haemolysed sera should not be used.
Do not use plasma.
Always centrifuge serum immediately before assay.
Sera with unusually low or unusually high protein concentrations give erroneous results.
Always store frozen serum samples carefully and do not allow increases in temperature above -20 °C. Incorrect storage can lead to loss of antibody activity.
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