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. 2024 Jan 4;36:12115. doi: 10.3389/ti.2023.12115

TABLE 3.

Summary of literature review on GEP for clinical and subclinical acute rejection.

Authors Study design Biomarker Number of samples Results
[4] Multicenter; multiple biorepository retrospective validation sets 17 gene signatures 237 For subAR (including BL) vs. No rejection. AUROC 0.83, NPV 0.89; PPV 0.73
RNA seq (Tuteva) 46 subAR For AR (including BL) sets vs. No rejection AUROC 0.81–0.97 (in biorepository validation sets)
145 No rejection
[1] Multicenter prospective, internal validation for discovery and validation sets 57 gene signature Microarray/qPCR (120 genes)
(TruGraf)
382
143 subAR
239 stable
For subAR (including BL) vs. Stable. AUROC 0.85
NPV 0.88/PPV 0.61
[7] Post-hoc analysis from a prospective observational Combined 408 For subAR (including BL) vs. Stable AUROC 0.75, NPV 0.82, PPV 0.47
TruGraf + dd-cfDNA 103 subAR
325 stable
[19] Multicenter with external retrospective sample validation 23 gene signature RNA seq (Clarava) 155 For AR (mostly subAR + cAR including BL) vs. No rejection AUROC 0.74, NPV 0.88, PPV 0.70
For discovery set: 32 AR (cAR + subAR)
49 no rejection
[20] Multicenter prospective, internal validation for discovery and validation sets 13 12-gene signature/RT-PCR fluidigm (kSORT) 558 For AR (subAR and cAR including BL) vs. No rejection AUROC 0.95; Sen 0.92, Spec 0.93
187 AR (cAR + subAR)
371 No rejection
[21] Multicenter validation cohort 17-gene rt-PCR (kSORT) 1763 For AR (cAR +subAR including BL) vs. No rejection AUROC 0.51
188 AR (cAR +subAR)
1575 No rejection
[22] Multicenter retrospective, internal validation for discovery and validation sets 5-gene signature RT-PCR/RNAseq (Allomap kidney) 191 For AR (cAR +subAR) vs. stable AUROC 0.78
47 AR (cAR +subAR) NPV 0.9–0.95, PPV 0.23–0.48
146 stable
[23] Multicenter, prospective validation cohort 5-gene signature RT-PCR/RNA seq (Allomap kidney) 235 For AR (clinical and subclinical) vs. stable Sen 0.7, Spec 0.66 NPV 0.95
66 AR
169 stable
[24] Multicenter prospective, internal validation for discovery and validation sets 8-gene signature 384 For ABMR (cAR +subAR) vs. no ABMR AUROC 0.80 NPV 0.96, PPV 0.26
RT-PCR/RNAseq 186 ABMR (cAR +subAR)
248 no ABMR

ABMR, antibody-mediated rejection; AR, acute rejection; AUROC, area under the receiver operating characteristic curve; BL, borderline; cAR, clinical acute rejection; subAR, subclinical acute rejection; NPV, negative predictive value; PPV, positive predictive value; Sen, sensitivity; Spec, specificity.