Autoantibody To Thyroglobulin (TGAb) Kit (Chemiluminescence Immunoassay)

Methodology                                                                                                         

Chemiluminescence Immunoassay

Product Show                                                                                                                                                                                         

TGAb                                                                                                                       

Autoantibody To Thyroglobulin (TGAb) Kit (Chemiluminescence Immunoassay) is intended for in vitro quantitative determination of autoantibodies to thyroglobulin (TGAb) content in human serum, based on NRM411 system.
Thyroglobulin (TG) is a 660 kDa, dimeric protein produced by the follicular cells of the thyroid, and a precursor of the thyroid hormones thyroxine (T4) and triiodothyronine (T3), which is stored in the thyroid follicular cavity. TGAb content in serum is a specific index for the diagnosis of autoimmune thyroid disease.

Clinical Significance                                                                                              

Elevated serum concentrations of TGAb are usually found in subjects with autoimmunity-based thyroiditis. 80%~90% of patients with chronic thyroiditis and 60% of patients with Hyperthyroidism are found with elevated serum concentrations of TGAb. The highest positive incidence of TGAb is found in Hashimoto's thyroiditis, and secondarily found in primary hypothyroidism. Thus, the test of TGAb has great significance for the diagnosis of Hashimoto's thyroiditis and primary hypothyroidism.

Test Principle                                                                                                          

The assay is a sandwich immunoassay for quantitative determination of TGAb concentration based on chemiluminescence immunoassay technology. The Magnetic Microbeads Reagent contains protecting reagents and magnetic microbeads that are coated with biotin labeled TG antigen. The Antibody Reagent contains the protecting reagents and acridinium ester labeled goat anti-human IgG antibody. Auxiliary Reagent contains protecting reagents. Sample, calibrator or control is mixed with Magnetic Microbeads Reagent, Antibody Reagent and Auxiliary Reagent to form a sandwich complex. After incubation and automatic magnetic separation conducted by the instrument, trigger solutions are added to generate chemiluminescent reaction and the relative light units (RLUs) are measured by a photomultiplier. A proportional relationship presents between the concentration of TGAb in the sample and the RLUs detected by the NRM411 system.

Packages                                                                                                                 

100 Tests/Box, 200 Tests/Box.

Storage and Stability                                                                                            

Sealed: Stable until the expiry date when stored at 2-8ºC.
Opened: Stable for 4 weeks for reagents. Stable for 1 week after dissolved for the control material. To ensure the kit's best performance, it is recommended to place opened kits in the refrigerator if it's not going to be used on board during the next 12 hours.
Do not use it beyond the expiration date.

Calibration and Traceability                                                                                

Calibration
Each batch of kits contains specific calibration information, stored in the Calibration Card.
Traceability
The TGAb assay is traceable to an international reference reagent (NIBSC code: 65/093).