ENGVALL et al. V. DAVID et al. - Page 10




                more than one of an antibody’s binding sites, the binding strength is referred to as avidity.  Where                     
                multivalent bonding is involved the avidity is orders of magnitude greater than the sum of the                           
                affinities for each antigenic determinant and each antibody binding site.   Avidity is also relevant to35                                             
                antibodies bound to a substrate, such as used in immunometric assays.  The close proximity of the                        
                immobilized antibodies to each other on the carrier surface tends to give an avidity or functional                       
                affinity which is substantially higher than the affinity constant for the free antibody.36                               
                        Specificity is another important property related to antibodies.  Specificity is the ability of an               
                antibody to discriminate between  the antigen against which it was made (the immunogen) and any                          
                other antigen.   The converse of specificity is cross-reactivity, the tendency of an antibody to interact37                                                                                                         
                with antigens other than its immunogen.   Generally, the affinity constant for a cross-reaction is38                                                                           
                lower than the affinity constant for the reaction between an antibody and its immunogen.39                               
                        Immunoassays are diagnostic techniques which utilize the specificity and reactivity of antigens                  
                and antibodies to detect or quantitate antigens or antibodies in a solution.   Immunometric or40                                     
                "sandwich" assays of the type set forth in the count are used to determine the presence and/or                           
                concentration of a particular antigen in a fluid.   One type of immunometric assay uses a solid41                                                                    
                insoluble substrate or carrier having antibodies for a particular antigen bound to the carrier surface.                  
                A fluid thought to contain the antigen of interest is contacted with the carrier.  If present, the antigen               
                reacts with the carrier-bound antibody forming a complex.  Free labeled antibody which also reacts                       
                with the antigen is added, simultaneously or subsequently,  to the solution. The free labeled antibody                   
                reacts with the bound antigen.   This two-part reaction  results in an insoluble three-part complex in                   
                the form of a sandwich.  The substrate-bound and the labeled antibodies form the "bread" while the                       


                        35                                                                                                               
                                IMMU,  p. 6.3.                                                                                           
                        36                                                                                                               
                                FUND, p. 432-33.                                                                                         
                        37                                                                                                               
                                FUND, p. 440.                                                                                            
                        38                                                                                                               
                                FUND,  p. 440.                                                                                           
                        39                                                                                                               
                                FUND, p. 440.                                                                                            
                        40                                                                                                               
                                FUND, pp. 433-440.                                                                                       
                        41                                                                                                               
                                Engvall specification, p. 4.                                                                             
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