Operational checks for real-time urinary biomarker measurements for assessment of the quality of deceased donor kidneys

Lateral flow devices (LFDs) were integrated into the clinical organ procurement workflow of two organ procurement organizations (OPOs) to obtain measurements of urinary biomarkers uromodulin (UMOD), osteopontin (OPN), and chitinase-3-like protein 1 (YKL-40) in deceased donors. We report on the feasibility of expanding the procurement workflow with this point-of-care testing, as well as methods of monitoring study performance and sample integrity through quality checks (QCs). Data QCs were implemented at OPO sample collection, transport/storage, processing, sample shipment back to the data coordinating center, and data transcription. From April 2022 to April 2025, 62 laboratory staff at two OPOs measured repair biomarkers of 958 samples from 879 unique donors. 4% of samples (n = 35) were excluded due to sample QCs, such as being left unfrozen beyond acceptable protocol ranges. These exclusions resulted in 923 samples from 851 unique donors [720 donors after brain death (DBD), 131 donors after circulatory death (DCD)]. Median processing time of LFD biomarker measurements across OPOs was 46 min (IQR: 40–55) and 5.1% cases required LFD remeasurement due to invalid readings. Developed QCs were used to identify samples suitable for research purposes and have been summarized into a checklist for use in multidisciplinary sciences.