Open AccessValidation of a gene expression signature to measure immune quiescence in kidney transplant recipients in the CLIA setting
Author(s) -
Rocky Cheung,
Hua Xu,
Xia Jin,
W. Tian,
Kevin G. Pinney,
Lihong Bu,
Steven Stone,
Robert N. Woodward,
Nikhil Agrawal,
Shamik Dholakia,
Ryan T. Phan
Publication year - 2022
Publication title -
biomarkers in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.652
H-Index - 44
eISSN - 1752-0371
pISSN - 1752-0363
DOI - 10.2217/bmm-2022-0113
Subject(s) - medicine , kidney transplantation , immune system , kidney transplant , kidney , coefficient of variation , transplantation , immunology , oncology , pathology , statistics , mathematics
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, multi-center 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.