Chronic kidney disease (CKD) is a serious condition characterized by the gradual loss of kidney function. It is estimated that 1 in 10 adults worldwide suffers from some degree of CKD, often without noticeable symptoms until the later stages. By the time the disease is detected through traditional parameters, significant and often irreversible damage has already occurred.
Early detection is therefore critical. Correctly identifying patients at risk and starting appropriate treatment can significantly slow down the progression of CKD and, in many cases, prevent its transition to end-stage renal disease, when dialysis or transplantation becomes necessary.
Limitations of current diagnostic markers
In routine clinical practice, glomerular filtration markers such as creatinine or estimated glomerular filtration rate (eGFR) are commonly used. While they provide important information, these markers have clear limitations:
- they primarily reflect glomerular rather than tubular function,
- changes often appear only in more advanced disease stages,
- results may be influenced by patient characteristics such as muscle mass or calculation method.
This means that by the time traditional markers detect an abnormality, valuable opportunities for early intervention may already be lost.
Uromodulin: a unique serum biomarker
This is where Uromodulin (UMOD) comes into focus. Uromodulin is a kidney-specific protein, produced exclusively in the thick ascending limb of Henle’s loop and the early distal tubule. Its serum concentration reflects the integrity of the tubular system, making it an ideal candidate for detecting early tubulointerstitial damage – often before any drop in eGFR is visible.
The advantages of Uromodulin as a biomarker are clear:
- Early sensitivity – reacts earlier than conventional glomerular markers.
- Correlation with kidney function – correlates with eGFR but captures changes even at normal filtration.
- Risk identification – allows recognition of patients in CKD stages 1–2.
- Reliable in normal creatinine – detects cases where creatinine appears normal but tubular damage is already present.
- Stability – Uromodulin is highly stable in serum, making it suitable for routine laboratory use.
These features make Uromodulin not only a promising research parameter but also a practical diagnostic tool.
Expanding from ELISA to CLIA
BioVendor was the first company to bring a CE-IVD ELISA Uromodulin kit to the market, providing laboratories and researchers with access to this unique biomarker. Building on this pioneering step, the next milestone is its transfer to the CLIA (chemiluminescent immunoassay) platform.
Our new CLIA Uromodulin kit, developed for the KleeYa® analyzer, enables:
- fully automated measurement from serum samples,
- high-throughput capacity of up to 120 tests per hour,
- results available within just 15 minutes,
- seamless integration into routine diagnostic workflows.
This technological leap makes Uromodulin testing not only faster but also scalable for large laboratories and hospital settings.
Validation in clinical practice
At EuroMedLab 2025 in Brussels, BioVendor R&D presented the poster “Human Uromodulin: Unique Serum Biomarker for Evaluation of Kidney Damage.” The work, presented by Eva Bače, Head of CLIA Development at BioVendor R&D, highlighted the clinical relevance of Uromodulin in providing a new diagnostic perspective on CKD.
The study was co-authored by experts from the Clinical Biochemistry Laboratory at the University Hospital Olomouc, Czech Republic, who confirmed the practicality of Uromodulin testing and emphasized its potential benefits in daily clinical diagnostics. Their positive reception underlines the readiness of this biomarker to transition from research into real-world clinical application.
A step forward in kidney diagnostics
The introduction of CLIA Uromodulin represents more than just a technical innovation – it provides healthcare professionals with a new diagnostic lens. By combining early sensitivity, reliability, and automated high-throughput testing, Uromodulin offers an effective solution for improving patient outcomes in kidney disease.
BioVendor’s mission has always been to translate innovation into practice. By expanding Uromodulin testing from ELISA to CLIA, we are ensuring that this biomarker can be used routinely and efficiently, helping laboratories worldwide deliver earlier and more precise diagnostics for CKD.
