Anti-CCP iClia

Intended Use

Anti-CCP iCLIA Kit is intended for the in vitro quantitative measurement of anti-cyclic

citrullinated peptides antibodies (Anti-CCP) in human serum/plasma as an aid in the diagnosis of rheumatoid arthritis (RA) and other related disorders. 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 : 2.00 RU/mL
• Linearity: 2.00 RU/mL to 400 RU/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-CCP iCLIA is an Indirect Chemiluminescence immunoassay using microparticle

acridinium ester chemiluminescent technology. In the first step, magnetic microparticle coated with CCP Antigen, human serum and assay buffer are mixed and incubated in an assay cup which allows patient specific anti-CCP 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-CCP 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-CCP 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 RU/ml.

Performance Characteristics

Limit of Blank (LoB): ≤0.500 RU/mL

Accuracy: The accuracy of Anti-CCP 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-CCP 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-CCP 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-CCP antibody positive samples (Weak and strong) and kit controls in between instrument precision testing with CV <15%.

Ordering Information