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Profile of the Pleximmune blood test for transplant rejection risk prediction
Rakesh Sindhi1, Chethan Ashokkumar1, Brandon W Higgs1
1a Department of Transplant Surgery , Thomas E. Starzl Transplantation Institute, Hillman Center for Pediatric Transplantation, Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center (UPMC) , Pittsburgh , PA , USA.
Insights
The new Pleximmune™ test predicts acute cellular rejection in pediatric liver and intestine transplant patients. This FDA-approved, cell-based test aids in optimizing immunosuppression and improving transplant outcomes.
Area of Science:
- Transplantation immunology
- Pediatric gastroenterology
- Medical diagnostics
Background:
- Acute cellular rejection (ACR) is a major complication following pediatric liver and intestine transplantation.
- Current immunosuppression management strategies carry risks of infection and malignancy, and high graft loss rates (up to 50% at 5 years) persist, particularly after intestine transplantation.
- There is a critical need for predictive tools to guide immunosuppression and improve long-term graft survival in pediatric transplant recipients.
Purpose of the Study:
- To evaluate the performance of the Pleximmune™ test, a novel cell-based assay, in predicting acute cellular rejection in children undergoing liver or intestine transplantation.
- To assess the potential of the Pleximmune™ test to guide immunosuppression management and improve patient and graft outcomes.
Main Methods:
- The study involved a training and validation set analysis of 214 pediatric patients who received liver or intestine transplants.
- The Pleximmune™ test, a US FDA-approved cell-based assay, was utilized to predict acute cellular rejection.
- Performance metrics including sensitivity and specificity were calculated.
Main Results:
- The Pleximmune™ test demonstrated a sensitivity of 84% and a specificity of 80% for predicting acute cellular rejection in the studied pediatric cohort.
- These results indicate the test's capability to identify patients at risk of rejection.
- The test's predictive power contrasts with current diagnostic methods like biopsy, which detect rejection but do not predict it.
Conclusions:
- The Pleximmune™ test is a valuable tool for predicting acute cellular rejection in pediatric liver and intestine transplant recipients.
- Accurate prediction of cellular immune responses is crucial for optimizing immunosuppression, reducing complications, and achieving durable graft survival.
- This cell-based assay addresses an unmet clinical need in managing pediatric transplant patients.
Abstract:
The Pleximmune™ test (Plexision Inc., Pittsburgh, PA, USA) is the first cell-based test approved by the US FDA, which predicts acute cellular rejection in children with liver- or intestine transplantation. The test addresses an unmet need to improve management of immunosuppression, which incurs greater risks of opportunistic infections and Epstein-Barr virus-induced malignancy during childhood. High-dose immunosuppression and recurrent rejection after intestine transplantation also result in a 5-year graft loss rate of up to 50%. Such outcomes seem increasingly unacceptable because children can experience rejection-free survival with reduced immunosuppression. Pleximmune test sensitivity and specificity for predicting acute cellular rejection is 84% and 80% respectively in training set-validation set testing of 214 children. Among existing gold standards, the biopsy detects but cannot predict rejection. Anti-donor antibodies, which presage antibody-mediated injury, reflect late-stage allosensitization as a downstream effect of engagement between recipient and donor cells. Therefore, durable graft and patient outcomes also require accurate management of cellular immune responses in clinical practice.
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