Thyroid TPOAb Chemiluminescence Immunoassay Kit

Methodology                                                                                                         

Chemiluminescence Immunoassay

Product Show                                                                                                        

TPOAb                                                                                                                     

Autoantibody To Thyroid Peroxidase (TPOAb) Kit (Chemiluminescence Immunoassay) is intended for in vitro quantitative determination of antibodies to thyroid peroxidase (TPOAb) content in human serum, based on NRM411 system.
Thyroid peroxidase (TPO) is an enzyme expressed mainly in the thyroid where it is secreted into colloid. It oxidizes iodide ions to form iodine atoms for addition onto tyrosine residues on thyroglobulin thus catalyses the production of thyroxine (T4) or triiodothyronine (T3). TPOAb is one of the main thyroid  autoantibodies thus closely related to autoimmune thyroid disease.

Clinical Significance                                                                                              

Combined with increased concentration of TSH, TPOAb test can help identify patients with early hypothyroidism. Also, TPOAb test can help distinguish patients with primary hypothyroidism and secondary hypothyroidism. TPOAb test is mainly for diagnosis of Hashimoto's disease, autoimmune hyperthyroidism and Graves disease. Some autoimmune diseases such as rheumatoid disease, systemic lupus erythematosus (SLE) can be observed with elevated levels of TPOAb.

Test Principle                                                                                                          

The assay is a sandwich immunoassay for quantitative determination of TPOAb concentration based on chemiluminescence immunoassay technology. The Magnetic Microbeads Reagent contains protecting reagents and magnetic microbeads that are coated with biotin labeled TPO 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 TPOAb 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 TPOAb assay is traceable to a NIFDC standard reference reagent Anti-Tpo Ab (Lot No. 150557-200601 ).