Division of Nephrology, Department of Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
Transplant Genomics Inc., Mansfield, MA, USA.
Clin Transplant. 2021 Jan;35(1):e14145. doi: 10.1111/ctr.14145. Epub 2020 Nov 24.
TruGraf™ blood test measures a specific gene expression signature in peripheral blood mononuclear cells for noninvasive assessment of kidney transplant recipients (KTRs) with stable renal function, excluding subclinical acute rejection (subAR) with high degree of confidence. Study objective was to correlate TruGraf™ test with 6-month surveillance biopsy (SBx).
Prospective, single-center study of 116 consecutive KTRs with SBx performed at 6 months post-transplant..TruGraf™ done at time of SBx; results compared with histology (Banff 2017) for concordance.
Of 116 enrollees, 26 excluded, absent biopsy (n = 17), test quality control issues (n = 9), leaving 90 KTRs-66% deceased donor kidneys, 58% African American, and 59% male. TruGraf™ result negative in 67 subjects; 54 had normal biopsy, indicating SBx could have been avoided. Eight subjects had true positive result where biopsy justified. Unnecessary biopsy would have been performed in 15 subjects with false-positive TruGraf™, and subAR missed in 13 subjects with false-negative test. In overall population of 90 patients, SBx would have been avoided in 54 (60%).
Implementation of TruGraf™ testing in a "real-world" cohort at the time of SBx identified a significant proportion of KTRs that could have avoided SBx.
TruGraf™ 血液检测测量外周血单个核细胞中的特定基因表达特征，用于对肾功能稳定的肾移植受者（KTR）进行非侵入性评估，排除具有高度置信度的亚临床急性排斥反应（subAR）。研究目的是将 TruGraf™ 检测与 6 个月监测活检（SBx）相关联。
这是一项前瞻性、单中心研究，纳入了 116 例连续接受 SBx 的 KTR。在移植后 6 个月进行 TruGraf™ 检测；将结果与组织学（Banff 2017）进行比较，以评估一致性。
在 116 名入组者中，有 26 人被排除，其中 17 人未进行活检，9 人存在检测质量控制问题，其余 90 名 KTR 中有 66%是尸肾供者，58%是非洲裔美国人，59%是男性。67 名受试者的 TruGraf™ 检测结果为阴性；其中 54 人的活检结果正常，表明可以避免进行 SBx。8 名受试者的 TruGraf™ 检测结果为真阳性，活检结果证实了这一点。如果将 TruGraf™ 检测结果为假阳性的 15 名受试者进行活检，会进行不必要的活检，而将假阴性的 13 名受试者的亚临床急性排斥反应漏诊。在总体 90 例患者中，有 54 例（60%）可以避免进行 SBx。
在 SBx 时对真实世界队列中的 TruGraf™ 检测进行实施，发现可以避免 SBx 的 KTR 比例显著增加。
