CLIA Uromodulin

Description

Chronic kidney disease (CKD) represents a serious health problem affecting more than 10% of the global population. It often progresses silently, without obvious symptoms until advanced stages. Early detection is crucial for slowing disease progression and preventing severe complications such as the need for dialysis or transplantation.

In clinical practice, although we have reliable indicators of glomerular filtration (e.g., creatinine or eGFR), we lack a marker for renal tubular function. Kidney damage often begins at the tubular level, not the glomeruli. If we monitor only glomerular function, the problem may be detected only in later stages.

Uromodulin (UMOD) is a specific protein produced exclusively in the kidneys, whose concentration sensitively reflects the functional integrity of the tubular apparatus and enables detection of kidney damage even before eGFR declines.

Main advantages of uromodulin:

UMOD, also known as Tamm-Horsfall protein, is produced exclusively by epithelial cells of the renal tubules. It is released into both urine and bloodstream, with serum levels better reflecting the current state of the kidneys than urinary levels.

A decrease in UMOD concentration below a defined threshold signals reduced kidney function and can reveal CKD risk earlier than changes in traditional parameters such as creatinine.

CLIA Uromodulin can be quantified in serum with results available within 20 minutes. Due to its high specificity and sensitivity, it represents a reliable tool for prevention and early detection of kidney disease.

Technical data

• Assay time: 20 min
• Assay stability: 30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C
• Sample matrix: Serum
• Sample volume: 10 μL
• Measuring range: 15 – 800 ng/ml
• Complementary products: Anchor® Tips, Stackable Cuvette, KleeYa Trigger Pack, KleeYa Wash buffer
• Note: The kits are CE-IVD certified and intended for professional use.

Specifications

• Catalog Number: CL-UMOD050
• Size: 50 tests
• Regulatory status: CE IVD
• Clinical topic: Renal Diseases
• Producer: TestLine Clinical Diagnostics s.r.o.

References

• 28613246,28858977,28089453,28151855,24933630,29698955,28206617,26962815,27790922
• Kuśnierz-Cabala B, Gala-Błądzińska A, Mazur-Laskowska M, Dumnicka P, Sporek M, Matuszyk A, Gil K, Ceranowicz P, Walocha J, Kucharz J, Pędziwiatr M, Bartuś K, Trąbka R, Kuźniewski M. Serum Uromodulin Levels in Prediction of Acute Kidney Injury in the Early Phase of Acute Pancreatitis. Molecules. 2017 Jun 14;22(6):988. doi: 10.3390/molecules22060988. PMID: 28613246; PMCID: PMC6152627.
• Leiherer A, Muendlein A, Saely CH, Brandtner EM, Geiger K, Fraunberger P, Drexel H. The value of uromodulin as a new serum marker to predict decline in renal function. J Hypertens. 2018 Jan;36(1):110-118. doi: 10.1097/HJH.0000000000001527. PMID: 28858977.
• Leiherer A, Muendlein A, Saely CH, Ebner J, Brandtner EM, Fraunberger P, Drexel H. Serum uromodulin is a predictive biomarker for cardiovascular events and overall mortality in coronary patients. Int J Cardiol. 2017 Mar 15;231:6-12. doi: 10.1016/j.ijcard.2016.12.183. Epub 2016 Dec 29. PMID: 28089453.
• Leiherer A, Muendlein A, Saely CH, Kinz E, Brandtner EM, Fraunberger P, Drexel H. Serum uromodulin is associated with impaired glucose metabolism. Medicine (Baltimore). 2017 Feb;96(5):e5798. doi: 10.1097/MD.0000000000005798. PMID: 28151855; PMCID: PMC5293418.
• Risch L, Lhotta K, Meier D, Medina-Escobar P, Nydegger UE, Risch M. The serum uromodulin level is associated with kidney function. Clin Chem Lab Med. 2014 Dec;52(12):1755-61. doi: 10.1515/cclm-2014-0505. PMID: 24933630.
• Bostom A, Steubl D, Garimella PS, Franceschini N, Roberts MB, Pasch A, Ix JH, Tuttle KR, Ivanova A, Shireman T, Kim SJ, Gohh R, Weiner DE, Levey AS, Hsu CY, Kusek JW, Eaton CB. Serum Uromodulin: A Biomarker of Long-Term Kidney Allograft Failure. Am J Nephrol. 2018;47(4):275-282. doi: 10.1159/000489095. Epub 2018 Apr 26. PMID: 29698955; PMCID: PMC6754623.
• Scherberich JE, Gruber R, Nockher WA, Christensen EI, Schmitt H, Herbst V, Block M, Kaden J, Schlumberger W. Serum uromodulin-a marker of kidney function and renal parenchymal integrity. Nephrol Dial Transplant. 2018 Feb 1;33(2):284-295. doi: 10.1093/ndt/gfw422. PMID: 28206617; PMCID: PMC5837243.
• Steubl D, Block M, Herbst V, Nockher WA, Schlumberger W, Satanovskij R, Angermann S, Hasenau AL, Stecher L, Heemann U, Renders L, Scherberich J. Plasma Uromodulin Correlates With Kidney Function and Identifies Early Stages in Chronic Kidney Disease Patients. Medicine (Baltimore). 2016 Mar;95(10):e3011. doi: 10.1097/MD.0000000000003011. PMID: 26962815; PMCID: PMC4998896.
• Steubl D, Block M, Herbst V, Schlumberger W, Nockher A, Angermann S, Schmaderer C, Heemann U, Renders L, Scherberich J. Serum uromodulin predicts graft failure in renal transplant recipients. Biomarkers. 2017 Mar;22(2):171-177. doi: 10.1080/1354750X.2016.1252957. Epub 2016 Nov 14. PMID: 27790922.

• Wash buffer
• Anchor tips
• Cuvettes
• Dispense cartridge