Future Science Group
suppl_data.docx (2.69 MB)
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bmm-2022-0113 supplementary data.docx

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posted on 2022-04-29, 08:47 authored by Rocky Cheung, Hua Xu, Xia Jin, Wenlan Tian, Kevin Pinney, Lihong Bu, Steven Stone, Robert N Woodward, Nikhil Agrawal, Shamik Dholakia, Ryan T Phan

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.




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