Successful transplant maintenance is a delicate balance of immunosuppression that reduces rejection risks without exposing patients to a greater risk of infectious diseases. Since infectious disease is one of the primary causes of morbidity and mortality in post-transplant patients, consistent testing is vital for confident clinical decision-making and preventing rejection.
Molecular testing has become the standard to detect and monitor viral infections in transplant patients due to its ability to quantify viral load, capacity to handle a high number of samples, and quick turn-around-time. Assessing viral load through a series of quantitative tests after transplantation can detect infectious syndromes, monitor those infections, and confirm response to therapy.
Quantitative molecular assays’ sensitivity provides clinicians with reliable values and key information to determine when to start, adjust, and end treatment. International standards for some quantitative assays and the development of viral load monitoring and disease management guidelines have increased standardization and enriched the quality of care.
Monitoring provides critical data
Three latent DNA viruses that can reactivate are of concern for transplant patients: Cytomegalovirus (CMV), Epstein–Barr virus (EBV), and BK polyomavirus (BKV). Each can cause disease or transplant rejection.
Serial monitoring for CMV, EBV, and BKV is crucial to transplant management because of its role in early detection and intervention for high-risk transplant recipients. Numerous studies support the use of quantitative molecular testing, particularly in determining therapy timing and effectiveness.
- Response to CMV treatment typically takes seven or more days, depending on the patient’s risk level. For high-risk patients, transplant centers may use preventive treatment for three to six months post-transplant and then conduct biweekly or monthly screening for another three to six months.1
- Increases in viral load are associated with EBV-related post-transplant lymphoproliferative disorder (PTLD). Tracking EBV DNA viral loads in high-risk patients can show if interventions are working as expected, and if not, it may indicate PTLD.
- Between 4% and 8% of kidney transplants fail due to BKV.2 A series of BKV screenings can help determine how and when to adjust immunosuppressants for a greater immune response.
Ensuring confidence in assay performance
Clinical laboratories play a vital role in the success of transplant programs and the monitoring of transplant-related viruses such as CMV, BKV, and EBV. Growing demand for transplants in the US and worldwide will only increase the need for comprehensive and reliable post-transplant monitoring.
Since viral diseases may not have specific clinical manifestations, establishing a diagnosis requires laboratory testing. The time-sensitive nature of monitoring post-transplantation patients requires unwavering confidence in assay performance from an objective assessment of its accuracy.
Manufacturer controls are often formulated from the same raw material as the assay calibrators. This will not challenge the assay at lower detection limits, making them less likely to identify assay performance degradation. Third-party controls are impartial and usually manufactured in human-based matrices to be patient-like.
Third-party controls are uniform, so monitoring and comparing results over time for post-transplantation patients is possible. They identify positive and negative results more accurately and maintain testing compliance and proficiency success. Lab data offers independent and reliable typical values, and considerable peer data is available from third-party suppliers.
Learn more about molecular testing and post-transplant management
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SeraCare’s quality measurement tools to support molecular transplant assays:
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Sources
- Infection in organ transplantation
- BKV, CMV, and EBV Interactions and their Effect on Graft Function One Year Post-Renal Transplantation: Results from a Large Multi-Centre Study
Additional references
Molecular immune monitoring in kidney transplant rejection: a state-of-the-art review
Diagnosis and Monitoring of Viral Infections in the Transplant Population