Assessing immune function in allogeneic and autologous bone marrow transplant recipients using the Cylex® immuknow™ assay

The Cylex Immune Cell Function Assay (ImmuKnow) is cleared by the FDA for the detection of cell-mediated immunity in an immunosuppressed population. The assay measures the immune function of CD4+ T-helper cells from a small sample of whole blood by stimulating the sample with phytohemagglutinin, selection of CD4+ cells with antibody coated magnetic particles, and detection of ATP by bioluminescence. CD4+ T-helper cells that respond to stimulating increase their production of ATP that provide an objective measure of immune responsiveness. This test has demonstrated clinical utility for managing immunosuppressive therapies in solid-organ transplantation (SOT). Outcome data from SOT recipients have identified risk zones for infection or allograft rejection based on immune function values determined by the ImmuKnow assay. Observational studies conducted at several cancer centers and Universities in the United States involving over 200 patients have shown that this test provides an independent measurement of engraftment, immune reconstitution, and immune function in allogeneic and autologous bone marrow transplant recipients. By assessing immune function in BMT recipients it is possible to avoid infectious complications, manage immunosuppressive therapy, and scheduling of chemotherapy.