Lateral Flow Assay to detect CXCL10 as a diagnose-supporting biomarker for Polyomavirus-associated Nephropathy (PVAN) after kidney transplantation (KTx)

Kidney grafts, as the most transplanted organs, require intensive monitoring to ensure optimal transplant survival rates for patients. These rates can be jeopardized by severe, difficult-to-treat opportunistic infections such as polyomavirus, which can lead to polyomavirus-associated nephropathy (PVAN). There is an urgent need for non-invasive biomarker tests to narrow down the number of patients who require a transplant biopsy to confirm PVAN. The chemokine CXCL10 was significantly elevated in urine samples from kidney transplant recipients (KTR) with biopsy-confirmed PVAN compared to KTRs with a protocol biopsy found to be normal (114.8 ± 177.3 pg/ml, n = 22 vs. 11.4 ± 22.3 pg/ml, p < 0.0001, n = 45). Therefore, we developed a lateral flow assay (LFA) for the detection of PVAN with an area under the curve (AUC) of 0.832 according to receiver operating characteristic analysis as a point-of-care test.