Immune function assay (ImmuKnow) as a predictor of allograft rejection and infection in kidney transplantation.

Background The Cylex ImmuKnow (IK) assay provides a rapid and quantitative assessment of T-cell-mediated immune function. Studies have shown correlations between ImmuKnow assay and adverse events, such as immunosuppression and low or high calcineurin inhibitor trough levels. We investigated the correlation between IK changes and rejection or infection in kidney transplant patients and studied the potential application of the IK assays in optimizing individual immunosuppressive therapy. Methods ImmuKnow assay was used to determine dynamic intracellular ATP changes in CD4 cells in 193 samples from 42 kidney transplant patients and 25 healthy subjects. Patients were categorized into rejection, infection, and event-free groups. The IK values were assayed and analyzed between kidney transplant patients and healthy controls. Results Most IK values fell between 200 and 599ng/mL from pre-transplantation to 30months post-transplantation. The mean IK values continuously increased throughout 30months. Incidental allograft rejection patients had significantly higher IK values compared with the event-free patients and controls. However, infection patients had significantly lower IK values. Seven days after treatment, IK values in rejection/infection patients were different compared with the values in autograft patients, and there was a significant correlation between calcineurin inhibitor (FK506) trough levels and IK values in rejection/infection patients. Serum creatinine levels in the rejection patients were significantly higher than those in the event-free patients, and C-reactive protein levels were significantly higher in the infection patients compared with the event-free patients. Conclusions The IK assay combined with other biomarkers can be used to identify kidney transplant patients at high risk of rejection and infection.