bmm-2022-0113 supplementary table

Aim: Allograft rejection remains a major cause of graft failure in kidney transplantation. Here the authors

report the validation of a non-invasive molecular diagnostic assay, AlloMap Kidney, using peripheral

blood. Methods: The AlloMap Kidney test is a gene expression profile utilizing the RNA-seq platform

to measure immune quiescence in kidney transplant patients. Results/Conclusions: Analytical validation

showed robust performance characteristics with an accuracy correlation coefficient of 0.997 and a

precision coefficient of variation of 0.049 across testing. Clinical validation from the prospective, multicenter

studies of 235 samples (66 rejection and 169 quiescence specimens) demonstrated the sensitivity

of 70% and specificity of 66% for allograft rejection, while the negative predictive value was 95% to

discriminate rejection from quiescence at 10% prevalence of rejection.