This study was approved by the University of Pittsburgh IRB (protocol 10110393). STA kidney specimens and biopsies diagnosed as TCMR or BKPyVN were selected from weekly clinical conferences conducted immediately prior to commencement of the study. Diabetes mellitus, hypertension, and glomerulonephritis were the three most common causes of end-stage kidney disease in these subjects. All patients received Thymoglobulin induction followed by dual maintenance immunosuppressive therapy consisting of mycophenolate mofetil and tacrolimus. Corticosteroids were tapered over the first 7 days and then discontinued. Histologic diagnoses were based on the Banff classification for kidney allograft pathology (17 (link)). Diagnostically relevant Banff scores for the TCMR patients were g0, v0, i2, ptc0, cg0, ci1, ct1 for all biopsies. The t -score was 2 in all biopsies, except for 1 biopsy in which it was t3. The core needle biopsy specimens (18 gauge) were fixed in formalin immediately and paraffin embedded within 24 h.
The patients (eight males, seven females) in the discovery cohort ranged in age from 32 to 84 years with mean values of 60.8, 56.2, and 51.6 in the STA, BKPyVN, and TCMR groups, respectively. Biopsies had been performed 23-526 days post-transplant (mean 263) and showed renal cortex with mild interstitial fibrosis and tubular atrophy. For the BKPyVN biopsies, the concentration of viral loads ranged from 2.38E+08 to 6.67E+10 copies per mL in the urine and 8.11E+03 to 3.85E+05 copies per mL in the plasma. All biopsies showed polyomavirus antigens on immunohistochemistry.
The patients (two males, seven females) in validation cohort ranged in age from 27 to 73 years with mean values of 52.7. Biopsies had been performed 74-106 days post-transplant (mean 88).
The patients (eight males, seven females) in the discovery cohort ranged in age from 32 to 84 years with mean values of 60.8, 56.2, and 51.6 in the STA, BKPyVN, and TCMR groups, respectively. Biopsies had been performed 23-526 days post-transplant (mean 263) and showed renal cortex with mild interstitial fibrosis and tubular atrophy. For the BKPyVN biopsies, the concentration of viral loads ranged from 2.38E+08 to 6.67E+10 copies per mL in the urine and 8.11E+03 to 3.85E+05 copies per mL in the plasma. All biopsies showed polyomavirus antigens on immunohistochemistry.
The patients (two males, seven females) in validation cohort ranged in age from 27 to 73 years with mean values of 52.7. Biopsies had been performed 74-106 days post-transplant (mean 88).
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