Anti-TPO iClia

Intended Use

Anti-TPO iClia Kit is intended for the in vitro quantitative measurement of anti-thyroid Peroxidase antibody (Anti-TPO) in human serum/plasma as an aid in the hashimoto thyroiditis and Graves’ disease in conjunction with other laboratory and clinical findings. This kit is only operational with J. Mitra CLIA Analyzer.

Salient Features

• Based on Indirect chemiluminescent microparticle immunoassay
• Acridinium Ester (AE) based kit for more accurate results
• Test result at 30 minutes
• Analytical sensitivity: 2.50 IU/ml
• Linearity: 2.50 IU/ml to 600 IU/ml
• Long shelf life: 12 months at 2-8^oC
• Onboard stability of reagents: 30 days at 2-8^oC
• Convenient pack size: 50 Test pack
• Prompt service back-up

Principle

Anti-TPO iClia is an indirect immunoassay using microparticle acridinium ester chemiluminescent technology .In the first step, magnetic microparticle coated with TPO Antigen, human serum and assay buffer are mixed and incubated in an assay cup which allows patient specific anti-TPO antibody to bind to microparticle. After sample matrix is removed by washing, AE conjugate (Anti-Human IgG antibodies linked to acridinium ester) is added and combined, and the Microparticle-TPO antigen/antibodies immune complex is kept with the help of a magnetic separator. Excess acridinium ester conjugate is removed by washing and finally the bound enzyme is detected by addition of chemiluminescent substrate; pre-trigger and trigger solution containing hydrogen peroxide and sodium hydroxide to the reaction mixture. The resulting chemiluminescent reaction is measured as relative Light units (RLUs). There is a direct relationship between the amount of Anti-TPO antibodies present in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the established calibration curve and Anti-TPOI concentration in the sample is expressed as IU/ml.

Performance Characteristics

Limit of Blank (LoB) : <1.00 IU/mL

Accuracy: The accuracy of Anti-TPO iClia was detected with 60 clinical specimens and compared with Roche CLIA. The co-relation co-efficient is ≥ 0.990.

Precision:

1. The test results are repeatable with Anti-TPO antibody positive samples (Weak and strong) and kit controls in within run precision testing with CV <10%.
2. The test results are reproducible with Anti-TPO antibody positive samples (Weak and strong) and kit controls in between run precision testing with CV <10%.
3. The test results are reproducible with Anti-TPO antibody positive samples (Weak and strong) and kit controls in between instrument precision testing with CV <15%.

Ordering Information