*Purpose: The objectives of this study were to model serial TruGraf testing in stable kidney transplant recipients and to demonstrate the potential clinical utility of serial TruGraf testing at a center not utilizing surveillance biopsies.

*Methods: We analyzed patients who had received TruGraf testing at multiple time points, at approximately three-month intervals. Serum creatinine levels, TruGraf test results, and retrospective clinical follow-up were obtained for 28 patients. Results were analyzed for test performance and impact on clinical decision making.

*Results: Overall accuracy of TruGraf, as compared with independent clinical assessment of testing was 77% (54/70); 79% (22/28) for test 1, 75% (21/28) for test 2 and 79% (11/14) for test 3. The false negative rate of the test was 1/70 (1.4%). The Principal Investigator (PI) independently reported that the TruGraf test provided clinical utility in all patients.The overall concordance between the TruGraf test and the clinical assessment was 77%. The false negative rate was extremely low at all time points (1.4%), indicating that very few patients would be identified as immune quiescent if they were not likely to be so. Two-thirds of false positives (who were truly negative) at the first time point were classified correctly as true negatives when re-tested at the second time point, indicating that serial testing would likely pick up most patients with stable renal function who are incorrectly classified as not likely to be immune quiescent on initial testing. In addition, no patient with a false TruGraf result of any kind (positive or negative) had worse renal function at the second time point as compared with the first, indicating no added risk to patients as a result of management with TruGraf.

*Conclusions: These data support the clinical utility of the TruGraf test as a potential alternative for surveillance biopsy in enabling transplant clinicians to evaluate patients with stable renal function with testing every three months to get an indication of whether they are likely to be adequately immunosuppressed and thus immune quiescent.

« Back to 2019 American Transplant Congress