Anti-IgE iClia

Intended Use

Anti-IgE iCLIA is used to quantitatively detect the concentration of total IgE antibodies in human serum samples in vitro, and is mainly used clinically for auxiliary diagnosis of human allergic reaction states. This kit is only operational in conjuction with J. Mitra CLIA Analyzer.

Salient Features

• Based on Sandwich chemiluminescent microparticle immunoassay
• Acridinium Ester (AE) based kit for more accurate results
• Test result within 31 minutes
• Linearity : 2.00 IU/ml to 1000 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 Tests
• Prompt service back-up

Principle

Anti-IgE iCLIA is a Sandwich immunoassay using microparticle acridinium ester chemiluminescent technology. In the first step, magnetic microparticle human serum and biotin-labeled mouse anti-human IgE are mixed and incubated in an assay cup for 10 minutes. After washing, add AE conjugate (Anti-IgE antibodies linked to acridinium ester) to assay cup and react for 10 minutes to form the solid-phase antibody-IgE-enzyme-labeled secondary antibody complex. The complex is washed to remove the unbound enzyme-labeled antibody and other substances. Finally pre-trigger and trigger solution containing hydrogen peroxide and sodium hydroxide solution is added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative Light units (RLUs). There is a direct relationship between the amount of total IgE 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-IgE concentration in the sample is expressed as IU/mL.

Performance Characteristics

Limit of Blank (LoB) :  <1.00 IU/ml

Accuracy: The accuracy of Anti-IgE iClia was detected with 60 clinical specimen and compared with Roche CLIA. The co-relation co-efficient is >0.990.

Precision:

1. The test results are repeatable with Anti-IgE samples (Low and High) and kit controls in within run precision testing with CV <10%.
2. The test results are reproducible with Anti-IgE samples (Low and High) and kit controls in between run precision testing with CV <10%.
3. The test results are reproducible with Anti-IgE samples (Low and High) and kit controls in between instrument precision testing with CV <10%.

Ordering Information