Method to diagnose and monitor cellular immune deficiencies

Abstract

A method and kit for determining candidates for immunotherapy, for monitoring the effect of immunotherapy and analysis of cell mediated immunity functionality in a patient who needs immunotherapy is provided. The method includes performing two intracutaneous skin tests and reading the skin test after twenty-four hours. One skin test is the administration of a mitogen such as phytohemagglutinin (PHA), concanavalin A (ConA), pokeweed antigen (PWA) and other mitogens as known in the art. The PHA skin test responses reflect the ability of the T-lymphocytes which are present to react to PHA and to release cytokines like IL-2 and induce a monocyte/macrophage infiltration leading to the DTH dermal reaction which is observed in the skin test characteristic of the afferent limb response of the immune system. The NCM (mitogen-stimulated natural cytokine mixture) skin test reflects the ability of preformed T-cell cytokines to induce the monocyte/macrophage accumulation characteristic of the efferent limb response.

What is claimed is:  
     
         1 . A method for monitoring the effect of immunotherapy in a patient undergoing immunotherapy including the steps of 
 administering an intracutaneous skin test with a mitogen and reading the skin test after twenty-four hours; and    administering an intracutaneous skin test with a natural cytokine mixture (NCM) and reading the skin test after twenty-four hours;    wherein patients who respond to the intracutaneous skin test correlate with positive clinical response to immunotherapy.    
     
     
         2 . The method as set forth in  claim 1  wherein said mitogen is phytohemagglutinin (PHA).  
     
     
         3 . The method as set forth in  claim 2  wherein the phytohemagglutinin is administered between the range of 0.5 to 1.0 μg.  
     
     
         4 . The method as set forth in  claim 1  wherein said mitogen is concanavalin A.  
     
     
         5 . The method as set forth in  claim 1  wherein said mitogen is pokeweed antigen.  
     
     
         6 . The method as set forth in  claim 1  wherein said NCM is administered at a dose of 0.1 ml which has an equivalence to 15 units of IL-2 by bioassay.  
     
     
         7 . The method as set forth in  claim 1  including the step of performing a white blood cell count and determining percent lymphocytes wherein a lymphocyte counts of <1500 mm 3  indicate a T-lymphocytopenia.  
     
     
         8 . A kit for the performance of the method set forth in  claim 1  including a mitogen selected from the group consisting of phytohemagglutinin, concanavalin A, pokeweed antigen and said natural cytokine mixture.  
     
     
         9 . A method to analyze cell mediated immunity in a patient needing such an analysis including the steps of 
 administering an intracutaneous skin test with a mitogen and reading the skin test after twenty-four hours; and    administering an intracutaneous skin test with a natural cytokine mixture (NCM) and reading the skin test after twenty-four hours;    performing a white blood cell count and determining percent lymphocytes    wherein a lymphocyte counts of <1500 mm 3  indicate a T-lymphocytopenia and patients who respond positively to the PHA intracutanecus skin tests have a functional afferent immune system response and patients who respond positively to the NCM intracutaneous skin tests have a functional efferent immune system response such that the functionality of the T-cells that are present can be determined.    
     
     
         10 . The method as set forth in  claim 9  wherein said mitogen is phytohemagglutinin (PHA).  
     
     
         11 . The method as set forth in  claim 10  wherein the phytohemagglutinin is administered between the range of 0.5 to 1.0 μg.  
     
     
         12 . The method as set forth in  claim 9  wherein said mitogen is concanavalin A.  
     
     
         13 . The method as set forth in  claim 9  wherein said mitogen is pokeweed antigen.  
     
     
         14 . The method as set forth in  claim 9  wherein said NCM is administered at a dose of 0.1 ml which has an equivalence to 15 units of IL-2 by bioassay.  
     
     
         15 . A method for selecting candidates for immunotherapy among patients who need immunotherapy including the steps of 
 administering an intracutaneous skin test with a mitogen and reading the skin test after twenty-four hours; and    administering an intracutaneous skin test with a natural cytokine mixture (NCM) and reading the skin test after twenty-four hours;    wherein patients who respond to both of the intracutaneous skin tests are candidates for immunotherapy.    
     
     
         16 . The method as set forth in  claim 15  wherein said mitogen is phytohemagglutinin (PHA).  
     
     
         17 . The method as set forth in  claim 16  wherein the phytohemagglutinin is administered between the range of 0.5 to 1.0 μg.  
     
     
         18 . The method as set forth in  claim 15  wherein said mitogen is concanavalin A.  
     
     
         19 . The method as set forth in  claim 15  wherein said mitogen is pokeweed antigen.  
     
     
         20 . The method as set forth in  claim 15  wherein said NCM is administered at a dose of 0.1 ml which has an equivalence to 15 units of IL-2 by bioassay.