Thyroid Autoantibody Immunological Test System

The Thyroid Autoantibody Immunological Test System is an in vitro diagnostic device used to detect autoantibodies associated with thyroid diseases like Hashimoto’s and Graves’ disease, aiding in diagnosis and treatment effectiveness. It uses specific assays to evaluate immune responses against thyroid tissue, identifying patients requiring further intervention.

Intended Use of Thyroid Autoantibody Immunological Test System

A Thyroid Autoantibody Immunological Test System is consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body’s own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto’s disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave’s disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.

Intended Use:

The Thyroglobulin Autoantibody Test is intended for the quantitative assessment of Thyroglobulin Antibody levels in human serum and plasma, employing the Access Immunoassay Systems. This test utilizes a chemiluminescent immunoassay method that uses paramagnetic particles. The measurement of thyroid autoantibodies can aid in the diagnosis of various conditions, including Hashimoto’s disease, nontoxic goiter, and Graves’ disease.

Device Description:

The Thyroglobulin Antibody Assay is a two-step immunoenzymatic (‘sandwich”) process that involves adding a sample to a reaction vessel coated with thyroglobulin protein. The TgAb binds to the thyroglobulin, and after incubation, the solid phase is held in a magnetic field. The thyroglobulin-alkaline phosphatase conjugate binds to the TgAb. After a second incubation, the solid phase is held in a magnetic field. The chemiluminescent substrate is added, and light produced is measured using a luminometer. The analyte concentration is automatically determined from a stored calibration.

System, Test, Thyroid Autoantibody

Intended Use:

Antibody assays are chemiluminescent immunoassays that quantitatively measure thyroperoxidase antibody (TPOAb) levels in human serum and plasma with Immunoassay Systems. TPOAb detection helps diagnose thyroid autoimmune disorders. In vitro assays also determine thyroid-stimulating autoantibodies targeting TSH receptors in serum and plasma samples. Measuring these autoantibodies, along with clinical findings, aids in diagnosing Graves’ Hashimoto’s disease, nontoxic goiter, and Graves’ disease.

Device Description:

The Thyroglobulin Antibody assay kit includes a reagent pack, calibrators, substrate, and wash buffers. It is run on Immunoassay Analyzers and includes a TSI bead pack, TSI reagent wedge, TSI adjustors, TSI controls, and Multi-Diluent solution. The device is a thyroid autoantibody immunological test system intended for in vitro diagnostic use to detect and measure autoantibodies against thyroid antigens in human serum or plasma. The test system consists of reagents and analytical components that use immunochemical techniques to bind specific thyroid autoantibodies present in patient specimens; after the antigen-antibody reaction, a labeled detection reagent generates a measurable signal that is proportional to the amount of autoantibody captured. The measured signal is processed by the system to produce a qualitative or quantitative result that aids in the diagnosis of autoimmune thyroid disorders such as Hashimoto’s disease, Graves’ disease, Nontoxic Goiter, Or Thyroid Cancer.

• Stability Studies
• Precision/Reproducibility
• Detection studies- Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
• Linearity/assay reportable range
• Traceability (controls, calibrators, or method)
• Analytical Sensitivity
• Analytical Specificity (Cross Reactivity)
• Interfering Substances
• Prozone effect study

Clinical Testing:

No Guidance available for 510k submission