The research results of the urine multi-miRNAs risk scoring model of the Ogen Diagnostic Team were invited to participate in ATC2024, which can be used for early diagnosis of BKVAN

BK polyomavirus-associated nephropathy (BKVAN) is a kidney disease caused by human polyomavirus BKV. The number of BKV-DNA copies in blood and urine, SV40 immunohistochemical staining, and dd-cfDNA are biomarkers of different stages of renal damage caused by BKV. The detection of the number of BKV-DNA copies in blood and urine can detect BKV infection at an early stage, but BKV infection does not necessarily cause renal damage, so it can only indicate the risk at an early stage; SV40 immunohistochemical staining is a test for the BKV expression protein SV40. When SV40 staining is positive, it indicates that BKV is in an active state of protein expression and BKV begins to exercise biological functions in the kidney. This method is affected by the sampling location and puncture depth; dd-cfDNA is a late marker of renal damage caused by BKVAN, especially when the urine dd-cfDNA is elevated, it indicates that BKV has caused renal damage.

So, is there a biomarker between the early risk and late damage of BKV that can be used as a diagnosis and earlier than the occurrence of kidney damage? The research of the Ogen Diagnostics R&D team found that the comprehensive risk score of multiple miRNAs in urine can be used as a new method for diagnosing BKVAN. At present, this research result has been confirmed to be invited to participate in the 2024 American Transplantation Conference (ATC2024) and be presented as a poster.

The Ogen Diagnostics R&D team analyzed the quantitative data of multiple miRNAs in the urine of 32 renal transplant recipients and found that there were significant differences in the levels of bkv-miR-B1-5p, bkv-miR-B1-3p and miR-21-5p between the simple BKV carrier group and the biopsy-confirmed BKVAN group (P=0.0079). The PymiR Score scoring model was established through logistic regression analysis and the optimal cutoff value (PymiR Score=71.78) was determined. The scoring model performed well in the training set (Sensitivity=76.9%, Specificity=100%, AUC=0.8681). In the validation set, it achieved a sensitivity of 72.73% and an AUC value of 0.8571. The diagnostic value of BKVAN was better than the detection of plasma BKV DNA copy number (0.8571 vs. 0.7266, P<0.05).

According to the central dogma of biology, RNA is transcribed from BKV-DNA and translated into protein, which can reflect the transcriptional activity of BKV-DNA. Recent studies have shown that the expression levels of bkv-miR-B1-5p and bkv-miR-B1-3p in the urine of kidney transplant recipients are associated with the occurrence of BKVAN. The abnormal expression of these miRNAs may be closely related to viral replication, immune response disorders, and kidney damage.

This study by the Ogen Diagnostics R&D team is the first in the world to simultaneously detect the levels of multiple miRNAs in the urine of kidney transplant recipients, and based on this, established the PymiR Score comprehensive risk scoring model , and verified the accuracy of the model in distinguishing simple BKV carriers and BKVAN patients, which is of great significance for the early clinical diagnosis of BKVAN.

About the American Transplant Congress (ATC)

The American Transplantation Conference (ATC) is the joint annual meeting of the American Society of Transplant Surgeons (ASTS) and the American Society of Transplantation (AST). It is one of the most influential academic events in the field of international organ transplantation. The conference focuses on hot topics in the field of global transplantation and brings together the latest cutting-edge scientific research results in organ transplantation. This year is the 15th ATC conference, and there will be more than 4,500 top experts and scholars in the field of organ transplantation from 54 countries attending the conference. It is expected that more than 600 cutting-edge scientific research results will be exhibited at this ATC.