ELEVATED IMMUNE RESPONSE IN RENAL TRANSPLANT RECIPIENTS AS MEASURED BY THE CYLEX威 IMMUKNOW™ ASSAY MAY PREDICT PATIENTS AT RISK OF REJECTION Leonard W. Liang,1 Richard J. Kowalski,2 Diane R. Post,2 Judith A. Britz,2 H. Albin Gritsch,1 Elaine F. Reed.1 1Immunogenetics Center, University of California Los Angeles, Los Angeles, CA; 2Cylex Inc., Columbia, MD The Cylex assay is FDA-approved for the detection of cell-mediated immunity in immunosuppressed patients. The assay measures immune cell function by determining the responsiveness of CD4⫹ lymphocytes to phytohemagglutinin stimulation in vitro. The assay may be an important tool by providing an objective measure of a patient’s immune status. We prospectively tested 13 renal transplant recipients with the Cylex assay prior to and up to 3 months after transplantation at UCLA. Blood samples were taken before transplantation and at weekly intervals post transplant. Ten of the 13 patients were clinically stable, with no evidence of acute rejection, delayed graft function, or infection. All 10 patients had low to moderate immune function both pre and post transplant. Three of the 13 patients received augmented immunosuppressive therapy after transplant. One patient had both acute cellular (ACR) and humoral rejection (HR) and systemic infection. The second patient had ACR and HR. The third patient had an adverse reaction secondary to IVIG treatment. All of these patients that experienced adverse post-transplant events had initial immune cell function responses greater than 525 ng/mL ATP (Strong Immune Response). During the time of clinical stability post-transplant, patients had low to moderate immune cell function. Of interest, 2 of 3 patients with immune responses ⬎525 ng/mL prior to transplant experienced early rejection episodes. The results suggest that patients exhibiting a strong immune response prior to transplant may be at higher risk of early adverse clinical events. Low and moderate T cell immune responses were seen during the course of clinically stable patients. Research was funded by the Cylex corporation, Columbia, Maryland