Intended Use
PROLACTIN iClia is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of PROLACTIN (PRL) in human serum and plasma. The assay kit is intended for in vitro diagnostic use. This kit is only operational in conjunction with CLIA-181 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: 10 µIU/ml
- Linearity: 10 µIU/ml – 10000 µIU/ml
- Long shelf life: 12 months at 2-8oC
- Onboard stability of reagents: 30 days at 2-8oC
- Convenient pack size: 50 Tests
- Prompt service back-up
Principle
PROLACTIN iClia is chemiluminescent immunoassay based on the “Sandwich” principle. The magnetic microspheres are coated with Anti- PROLACTIN antibodies.
The samples are added in the assay cup containing coated microspheres followed by addition of AE conjugate (Anti- PROLACTIN antibodies linked to acridinium ester) to assay cup. A sandwich complex is formed wherein PROLACTIN (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 PROLACTIN 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 PROLACTIN present in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the established calibration curve.
