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PRINCIPLE OF THE TEST
The CA15-3 ELISA test is an adapted solid phase sequential sandwich ELISA. Samples and biotinylatedmonoclonal antibody are added to wells coated with streptavidin. CA15-3 in the patient sample binds tobiotinylated capture antibody. The biotinylated antibody simultaneously binds to the streptavidin coatedplate. After a wash step, anti-CA15-3HRP enzyme conjugate is added and forms a sandwich aroundcaptured CA15-3. Unbound antibodies are washed off. TMB substrate is added resulting in thedevelopment of a blue color. The concentration of CA15-3 is directly proportional to the color intensitydeveloped. A standard curve is generated relating color intensity to CA15-3 concentration.