Anti-Thyroglobulin (Anti-Tg) ELISA

Enzyme immunoassay for the quantitative measurement of Anti-Thyroglobulin (Anti-Tg) autoantibodies in human serum.

INTENDED USE:For the quantitative measurement of Anti-Thyroglobulin (Anti-Tg) autoantibodies in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). Results shall be used in combination with other clinical and laboratory data to aid in the diagnosis of autoimmune thyroid diseases in the general population. This kit is intended for professional use only and is for laboratory use only. For in vitro diagnostic use only. Intended to be used manually but may be adaptable to open automated analyzers. The user is responsible for validating the performance of this kit with any automated analyzers.

GENERAL INFORMATION:Thyroglobulin represents the major protein found in the thyroid and is a dimeric glycoprotein of 660 kD. Thyroglobulin is produced by the thyroid gland and is involved in the storage and synthesis of thyroid hormones. It is a major autoantigen in autoimmune thyroiditis and is the precursor of T3 and T4. Although anti-Tg autoantibodies are found in conjunction with antiTPO autoantibodies, in the majority of cases of Hashimoto’s thyroiditis, Graves’ disease and Primary Myxedema, up to 1% of cases of hypothyroidism are associated with anti-Tg autoantibodies alone. The frequency of thyroglobulin antibodies is approximately 70–80% in subjects with autoimmune-thyroiditis, including Hashimoto’s disease, and approximately 30% in individuals with Graves’ disease. Anti-Tg autoantibodies are also associated with cases of mild hypothyroidism or hyperthyroidism and are frequently found in patients with other autoimmune diseases such as Rheumatoid Arthritis, Pernicious Anaemia and Type I Diabetes.

KIT CHARACTERISTICS:
- Method: ELISA
- Tests: 96
- Incubation Time / Conditions: 30, 30 (RT), 15-20 min (RT/dark)
- Standard Range: 40 - 2,000 IU/ml
- Sensitivity analytical: LoD: 2.061 IU/ml
- Final Sample Volume: 100 µl
- Sample Type: serum
- Sample Pretreatment: dilution 1:20
- Isotope / Substrate: TMB 450 nm
- Internal Controls: 2
- Regulatory Status: CE