Intended Use
Alpha-Fetoprotein Assay Kit is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of Alpha-Fetoprotein (AFP) in human serum and plasma. The assay kit is intended for in vitro diagnostic use.
Principle
The Alpha-Fetoprotein assay is a quantitative sandwich immunoassay to determine the presence of AFP in human serum and plasma using CMIA technology with flexible assay protocols.
- Sample, and paramagnetic anti-AFP coated microparticles are mixed, AFP present in the sample binds to anti-AFP coated microparticles, forming an antigen antibody complex.
- After incubation and washing, a conjugate containing acridinium-labeled anti-AFP is added to the reaction mixture and binds to unoccupied binding sites of the anti-AFP coated microparticles.
- After further incubation and 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 a relationship between the amount of AFP in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the previously established calibration curve
Storage
The kit should be stored upright, not upside down or horizontally. Store at 2–8°C with a validity period of 12 months.