E2 (Estradiol) iClia

Intended Use

E2 iClia is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of E2 (Estradiol) in human serum/plasma, as an aid in the diagnosis of ovarian disease in conjunction with other laboratory and clinical findings. The assay kit is intended for in vitro diagnostic use & is only operational in conjunction with J. Mitra CLIA Analyzer.

Salient Features

• Based on Competitive chemiluminescent microparticle immunoassay
• Acridinium Ester (AE) based kit for more accurate results
• Test result within 30 minutes
• Analytical Sensitivity: 15 pg/ml
• Linearity: 15 pg/ml – 2400 pg/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

E2 iClia is chemiluminescent immunoassay based on the “competitive” principle. The magnetic microparticles are coated with anti-E2 antibodies. The assay buffer, anti-E2 antibodies coated magnetic microparticles and samples are mixed and incubated in an assay cup. After incubation, E2 labelled AE conjugate is added to reaction mixture. During incubation AE labelled E2 and E2 in sample compete for the binding site of E2 antibody on the binding magnetic particle and the Microparticle-E2 antibody/E2 immune complex is kept with the help of a magnetic separator. Unbound acridinium ester and other substance are removed by washing. After washing, Pre-Trigger and Trigger Solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative Light units (RLUs). There is an indirect relationship between the amounts of E2 present in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the established calibration curve and E2 concentration in the sample is expressed as pg/mL.

Performance Characteristics

Limit of Blank (LoB): <10 pg/ml

Accuracy:The accuracy of E2 (Estradiol) iClia is tested with 60 clinical specimens and compared with Roche CLIA. The accuracy co-efficient is >0.980.

Precision:

1. The test results are repeatable in within run precision testing with CV <15%.
2. The test results are reproducible in between run precision testing with CV <10%.

Ordering Information