Intended Use
ANA Screen CLIA Kit is a chemiluminescent microparticle immunoassay intended for the
in vitro qualitative measurement of anti-Sm, dsDNA, Nuc, His, P0, PCNA, SSA, Ro52,
SSB/La, Scl-70, Jo-1, PM/SCl, CENP-B, nRNP/Sm, AMA-M2 antibodies in human serum/
Plasma as an aid in the diagnosis of Anti-nuclear antibodies related disease. 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 20 minutes
- Sensitivity: 100 %
- Specificity: 100%
- Long shelf life: 12 months at 2-8oC
- Onboard stability of reagents: 30 days at 2-8oC
- Convenient pack size: 50 Test pack
- Prompt service back-up
Principle
ANA Screen iCLIA is a chemiluminescent microparticle immunoassay based on the “indirect Principle”. In the first step, ANA antigen labeled magnetic microparticle, human serum/plasma and assay buffer are mixed and incubated in an assay cup, which allows patient specific anti-Sm/dsDNA/Nuc/His/P0/PCNA/SSA/Ro52/ SSB/La/Scl-70/ Jo-1/PM/SCl/CENP-B/nRNP/Sm/AMA-M2 antibodies to bind to microparticle. After sample matrix is removed by washing, anti-human IgG conjugated acridinium ester (AE Conjugate) is added and combined, and the Microparticle-ANA 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 acridinium ester is detected by addition of chemiluminescent substrate. The relative light unit (RLU) intensity is proportional to the amount of anti-ANA IgG. According to the anti-ANA IgG RLU-concentration standard curve, the RLU tested can be interpreted to anti-ANA IgG concentration in the sample expressed as RU/ml.