Urinary Extracellular Vesicles Biomarkers in CKD: Clinical Laboratory Translation

Area of Science:

• Nephrology
• Biomarker Discovery
• Clinical Diagnostics

Background:

• Chronic kidney disease (CKD) is a growing global health concern.
• Current kidney function tests (serum creatinine, eGFR, proteinuria) have limitations in early CKD detection.
• Urinary extracellular vesicles (uEVs) present a potential alternative for CKD diagnosis and monitoring.

Purpose of the Study:

• To review the biological evidence for uEV biomarkers in major CKD types.
• To critically examine laboratory and regulatory aspects for clinical translation of uEV assays.
• To outline a pathway for implementing uEV assays in routine diagnostics.

Main Methods:

• Literature review of biological evidence for uEV biomarkers in diabetic kidney disease, FSGS, IgA nephropathy, ADPKD, and lupus nephritis.
• Critical examination of pre-analytical and analytical factors for laboratory validation (ISO 15189).
• Discussion of regulatory pathways, laboratory-developed tests vs. commercial IVD platforms, and quality control needs.

Main Results:

• uEVs contain biomarkers reflecting the pathophysiological state of kidney cells.
• Significant pre-analytical and analytical variables require careful consideration for assay validation.
• Need for reference materials, internal quality control, and external quality assessment is highlighted.

Conclusions:

• uEVs hold potential for earlier CKD detection and precise phenotyping.
• Standardization, quality control, and regulatory navigation are crucial for clinical translation.
• Successful implementation of uEV assays can enhance personalized therapeutic monitoring in CKD.