International You Know About the Risk of Over-immunosuppression Potent immunosuppressive drugs have reduced the incidence of allograft rejection while increasing susceptibility to infection and malignancy2 Over-immunosuppressed patients are at increased risk for opportunistic infections, including reactivation of latent viral infections2 50%-75% of transplant patients will have evidence of microbial invasion in the first year posttransplant3 Immunosuppressant drug labeling must now include stronger warnings about the increased risk for viral infections related to over-immunosuppression4 The FDA recently recommended that transplant patients be monitored closely for signs of over-immunosuppression to reduce the risk of infection4 Immunosuppressant drug monitoring is insufficient for determining the level of immunosuppression or directing changes in treatment regimens5 ImmuKnow detects changes in CD4 cell ATP production, a known biomarker of global immune function7,8

The ImmuKnow assay is used to assess cell‐mediated immunity in immunosuppressed patients and is intended to be used as an adjunct to current immune function assessments. Used over time, the ImmuKnow assay provides important qualitative information about changes in immune function. 

Working from a baseline established for each patient, the ImmuKnow assay is repeated regularly for longitudinal, individualized assessment of changes in global immune status.

2. Fishman JA. Infection in solid-organ transplant recipients. N Engl J Med. 2007;357:2601-2614. 3. American Society of Transplantation. Infectious disease guidelines for transplantation. Am J Transplant. 2004;4(suppl 10):5-166. 4. The U.S. Food and Drug Administration. Information for healthcare professionals: immunosuppressant drugs: required labeling changes. http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm171654.htm. Accessed August 14, 2009. 5. The U.S. Food and Drug Administration. Class II Special Controls Guidance Document: cyclosporine and tacrolimus assays; guidance for industry and FDA. 2002. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm092778.htm. Accessed August 19, 2009. 7. Augustine NH, Pasi BM, Hill HR. Comparison of ATP production in whole blood and lymphocyte proliferation in response to phytohemagglutinin. J Clin Lab Anal. 2007;21:265-270. 8. Sottong PR, Rosebrock JA, Britz JA, Kramer TR. Measurement of T-lymphocyte responses in whole-blood cultures using newly synthesized DNA and ATP. Clin Diagn Lab Immunol. 2000;7:307-311.