1. A molecular signature of three urinary RNA species was sensitive and specific in identifying acute cellular rejection in kidney allografts.
2. The signature also shows prognostic values in predicting acute rejections that developed later.
Evidence Rating Level: 2 (Good)
Study Rundown: Proposed as a method to diagnose acute cellular rejections, urinary mRNA profiling has a significant advantage over the gold standard needle biopsy in that it is non-invasive. Additionally, the diagnostic signature may reveal forthcoming rejection that hasn’t shown up on biopsy yet, which is welcome news to clinicians that manage transplant patients. The downside is also apparent – sensitivity and specificity in the 70% range are impressive but may not be sufficient. Current sensitivity would miss roughly 2 out of every 10 acute cellular rejections.
In-Depth [prospective study]: The study evaluated urine mRNA measurement as a non-invasive diagnostic tool for acute cellular rejection. The study measured urinary mRNA levels of various protein products at multiple time points after transplantation up to 12 months.
The best fitting diagnostic signature contained the following three mRNA species: CD3ε chain, interferon-inducible protein 10 (IP-10), and 18S rRNA. ROC curve analysis showed that the three-gene signature had an area under curve, or AUC, of 0.85 (95% confidence inverval, [CI], 0.78 to 0.91; P<0.001). The diagnostic signature was 79% (95% CI, 67 to 91) sensitive and 78% (95% CI, 71 to 84) specific in discriminating between biopsy specimens with acute cellular rejection from those showing no rejection. In the external-validation data set, AUC dropped to 0.74. Sensitivity and specificity were also lower, at 72% and 71%, respectively.
The diagnostic signature remained flat and under the diagnostic threshold for specimens without rejection, whereas increased markedly during the 20-day period leading up to the first specimen showing acute cellular rejection.
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