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#53
PREDICTIVE VALUE OF THE CYLEX® IMMUKNOW™ ASSAY IN KIDNEY RECIPIENTS.
Richard J. Kowalski, PhD, Diane R. Post, Judith A. Britz, PhD, Rosyln B. Mannon, MD, John A. Daller, MD, PhD, Elaine F. Reed, PhD and James F. Burdick, MD. Columbia MD, USA, Cylex Inc., 21045, Product Development; Bethesda MD, USA, NIDDK/NIH/DHHS, 20892, Transplantation Branch; Galveston TX, USA, University of Texas Medical Branch, 77555, Surgery; Los Angeles CA, USA, University of California, Los Angeles, 90095, Immunogenetics Center and Bethesda MD, USA, Health Resources and Services Administration, 20814, Division of Transplantation.

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Long-term use of immunosuppressants is associated with significant morbidity and mortality in transplant recipients. Achieving the lowest therapeutic dose possible while minimizing adverse events is the objective of transplant physicians. A tool is now available to directly assess the net immunosuppressive state of a patient for individualizing therapy. A meta-analysis of 146 kidney recipients from four separate studies (Johns Hopkins, UCLA, NIDDK, and UTMB) was performed using the FDA-cleared Cylex® ImmuKnow™ assay. Blood samples were taken from recipients at various times post-transplant and compared with clinical course (stable, rejection, infection). In this analysis, 21 biopsy-proven cellular rejections, 19 opportunistic infections and 4 simultaneous rejection-infections occurred. A Fisher’s Exact test of recipients with values in the strong, moderate or low immune response zones showed a 4-fold relative risk of rejection for recipients with strong immune responses and a 3.77 increased relative risk of infection for recipients with low immune responses. The negative predictive value for recipients with moderate immune responses was greater than 90%, indicating that patients in the moderate zone were in general, clinically stable. These data show that the Cylex® ImmuKnow™ assay has predictive value in determining a transplant recipient’s response to immunosuppressive therapy.