Thyroid TG Chemiluminescence Immunoassay Kit

Methodology                                                                                                         

Chemiluminescence Immunoassay

Product Show                                                                                                                                                                                              



TG                                                                                                                           

Thyroglobulin (TG) Kit (Chemiluminescence Immunoassay) is intended for in vitro quantitative determination of thyroglobulin (TG) content in human serum, based on NRM411 system.
TG is a 660 kDa dimeric glycoprotein produced by the follicular cells of the thyroid. Human TG is a homodimer of subunits each containing 2768 amino acids and the storage of iodine in thyroid. When TG's tyrosine residues are combined with iodine, TG is cleaved to produce the thyroid hormones thyroxine (T4) and triiodothyronine (T3).

Clinical Significance                                                                                               The main application of TG testing is the post-operative follow-up of patients who have undergone a total or partial thyroidectomy. As the thyroid gland is the only known source of TG, the serum TG level will drop to a very low or undetectable concentration after total or near-total thyroidectomy. Besides, the thyroglobulin autoantibody, TGAb, can interfere the TG testing thus cause higher or lower results than the actual concentration.

Test Principle                                                                                                          The assay is a sandwich immunoassay for quantitative determination of TG concentration based on chemiluminescence immunoassay technology. The Magnetic Microbeads Reagent contains protecting reagents and magnetic microbeads that are coated with a biotin labelled anti-TG antibody. The Antibody Reagent contains the protecting reagent and acridinium ester labeled specific TG antibody. Sample, calibrator or control is mixed with Magnetic Microbeads Reagent and Antibody 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 TG 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 TG assay is traceable to an international reference material BCR-457.