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INTENDED USE:
The Diazyme ApoE4 Test Kit is designed to qualitatively determine the presence of ApoE4 antigens in human plasma. The test allows to determine if a sample is ApoE4 negative or positive and also allows to differentiate whether an ApoE4 positive sample is a genetic carrier of heterozygous (ApoE3/ApoE4) or homozygous (ApoE4/ApoE4) with a relatively high certainty.
In USA: For Research Use Only. Not for use in diagnostic procedures.
ASSAY PRINCIPLE:
Diazyme ApoE4 Test Kit is a sandwich chemiluminescent immunoassay that uses magnetic microbeads coated with an anti- ApoE4 monoclonal antibody for capturing, and anti-ApoE4 monoclonal antibody labeled with ALP for detection. Sample or calibrator or control is mixed with the capturing reagent, and the mixture is incubated at 37°C to form a complex. After sedimentation in a magnetic field, the antibody-ApoE4 complex is washed to remove unbound proteins and substances. Subsequently, the anti- ApoE4 monoclonal antibody labeled with ALP is added and all components are incubated again to form a sandwich complex. After washing the final complex, the substrate reagents are added, and a chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as RLU, and the signal is proportional to the concentration of ApoE4 present in the samples.