FSH iClia

Intended Use

FSH iClia is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of Follicle Stimulating Hormone (FSH) in human serum and plasma. The assay kit is intended for in vitro diagnostic use. 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: 0.4 mIU/ml
• Linearity: 0.4 mIU/ml to 200 mIU/ml
• Long shelf life: 12 months at 2-8^oC
• Onboard stability of reagents: 30 days at 2-8oC
• Convenient pack size: 50 Tests & 100 Tests
• Prompt service back-up

Principle

FSH iClia is chemiluminescent immunoassay based on the “Sandwich” principle. The magnetic microspheres are coated with Anti-FSH antibodies.

The samples are added in the assay cup containing assay buffer and anti-FSH antibodies coated microspheres followed by addition of AE conjugate (Anti-FSH antibodies linked to acridinium ester) to assay cup . A sandwich complex is formed wherein FSH (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 FSH 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 FSH 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):  ≤0.1 mIU/ml

Accuracy: The accuracy of FSH 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 <8%.
2. The test results are reproducible in between run precision testing with CV <15%.

Ordering Information