βHCG iClia

Intended Use

βHCG iClia kit is a chemiluminescent microparticle immunoassay designed for in vitro quantitative detection of βHCG in human serum or plasma. This kit is only operational in conjunction 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 30 minutes
• Analytical Sensitivity: 2 mIU/ml
• Linearity: 2 mIU/ml – 2500 mIU/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

βHCG iClia is a “Sandwich” immunoassay using microparticle acridinium ester chemiluminescent technology.

The samples are added in the assay cup containing assay buffer and anti-βHCG IgG antibodies coated microspheres followed by addition of AE conjugate (Anti-β-HCG antibodies linked to acridinium ester) to assay cup . A sandwich complex is formed wherein βHCG (from serum sample) is “trapped” or “sandwiched” between the microspheres coated antibody and antibody labelled with AE conjugate. Unbound conjugate is then washed off with wash buffer. The amount of bound AE conjugate is proportional to the concentration of βHCG present in the sample. 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 βHCG present in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the established calibration curve.

Performance Characteristics

Limit of Blank (LoB): 2 mIU/ml

Accuracy: The accuracy of βHCG iClia is tested with 60 clinical specimens and compared with Roche CLIA. The accuracy co-efficient is >0.990.

Precision:

1. The test results are repeatable in within run precision testing with CV <10%.
2. The test results are reproducible in between run precision testing with CV <10%.

Ordering Information