ID-ENTITY Trial- Evaluating Serial T-ID Monitoring

• To characterize time-updated viral detection patterns (e.g., transient vs sustained CMV or BK signals) identified by T-ID prior to development of CMV disease or BKVAN.
• To evaluate the clinical utility of T-ID monitoring, defined by the frequency and type of clinical management actions taken following test results.
• To estimate the diagnostic performance of T-ID for clinically meaningful viral infection compared with standard-of-care (PCR) testing and clinical adjudication.
• To quantify lead time between T-ID detection of viral cfDNA and standard-of-care confirmation or initiation of therapy.
• To assess the safety of biomarker-informed management, including both rejection following infection-directed management and infection following rejection-directed management.

Inclusion criteria

• Participants must meet all the following criteria:

• Written informed consent and HIPAA authorization obtained prior to any study-related data collection.
• Age ≥18 years at the time of enrollment.
• Recipient of a kidney transplant, including:
• Primary or repeat kidney transplantation
• Living-donor or deceased-donor transplantation
• At 1 month post-kidney transplant at the time of enrollment.
• Receiving maintenance immunosuppressive therapy per institutional standard of care.
• Selected by the treating provider to undergo TRAC testing as part of usual post-transplant clinical monitoring.

Exclusion criteria

• Recipient of a combined organ transplant involving a non-renal solid organ (e.g., kidney-liver, kidney-heart) and/or islet cell transplantation.
• History of prior non-renal solid organ transplantation or islet cell transplantation.
• Known pregnancy at the time of enrollment.
• Known active viral infection at enrollment with any of the following:
• Hepatitis B surface antigen (HBsAg)-positive
• Hepatitis B virus (HBV) nucleic acid testing (NAT)-positive
• Human immunodeficiency virus (HIV) infection or HIV NAT-positive
• *Known active BK virus-associated nephropathy (BKVAN) or CMV disease at the time of enrollment.
• Medical, psychiatric, or social condition that, in the opinion of the Investigator, would interfere with the participant's ability to provide informed consent or comply with study procedures.
• Concurrent participation in another investigational biomarker study designed to evaluate clinical utility of post-transplant molecular diagnostics.

• Participants with asymptomatic or low-level viral replication detected during routine clinical monitoring are eligible, provided there is no evidence of established CMV disease or BK virus-associated nephropathy at enrollment.