Advancing Accuracy in Chronic Kidney Disease Diagnosis and Management: Reference Materials and Reference Measurement Procedures for Clinical Markers.

Abstract

Chronic kidney disease (CKD) is a major non-communicable disease and a leading cause of mortality worldwide. With the increasing prevalence of risk factors such as diabetes mellitus, obesity, and hypertension in the 21st century, CKD currently affects over 10% of the global population. The clinical and economic burden of this widespread disease is projected to continue to rise worldwide. Early detection, treatment, and monitoring of this progressive condition through accurate clinical laboratory testing of CKD biomarkers are paramount to mitigate this growing healthcare challenge. The development of reference materials (RMs) and reference measurement procedures (RMPs) for these clinical analytes is pivotal to ensuring accurate measurements using in vitro diagnostics. In this review, we emphasize the importance of establishing RMs and RMPs to standardize the measurements of key clinical markers for CKD, i.e., urine and serum creatinine, urine albumin, serum cystatin C, and urea. Standardizing CKD biomarker measurements based on RMs and RMPs can help support global efforts to reduce CKD-related morbidity and healthcare costs by ensuring reliable diagnostic practices.