Intended Use
For the quantitative and qualitative detection of antibodies against the thyroid peroxidase (TPO) antigen in serum as an aid in the diagnosis of autoimmune thyroid disease. The test can be performed either manually or in conjunction with Mago® Plus automated systems.
For In Vitro Diagnostic Use.
Summary
Thyroid autoantibodies are frequently found in patients with autoimmune thyroid disease. The two most common of these autoantibodies are anti-bodies to thyroglobulin and thyroid peroxidase (or thyroid microsomal). Thyroglobulin is the major component of the thyroid follicular colloid. It is a 670,000 dalton glycoprotein produced by the thyroid epithelial cells. Thyroid peroxidase is a 110,000 dalton glycoprotein found in the cytoplasm and on the apical membrane of thyroid cells. Antibodies to thyroglobulin and thyroid peroxidase will be found in cases of Hashimoto's disease, myxedema, and Grave's Disease.
The Diamedix immunosimplicity (Is®) anti-TPO Test Kit is an EIA procedure intended for the qualitative detection or quantitation of antibodies to thyroid peroxidase antigen. The results are reported in International Units (IU) per ml, which are traceable to the WHO reference preparation 66/387 for anti-thyroid peroxidase antibodies.Principle of the Procedure
Purified TPO antigen from human thyroid gland is bound to microwells. Diluted patient sera, Standards and Controls are placed in the microwells and incubated. Anti-TPO IgG antibodies, if present, will bind to the antigen, forming antigen-antibody complexes. Residual sample is eliminated by aspirating and washing. Conjugate (horseradish peroxidase-labeled anti-human IgG) is added and will bind to these complexes. Unbound conjugate is removed by aspiration and washing. Substrate is then added and incubated. In the presence of bound enzyme, the substrate is converted to an end product. The absorbance of this end product can be read spectrophoto-metrically at 450 nm (reference 600-630 nm) and is directly proportional to the concentration of IgG antibodies to TPO present in the sample.
Please refer to complete Package Insert for greater detail about the test.
Features & Benefits
Formatted Procedures
