TABLE 3.
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.