Meet the cystatin C company at EuroMedLab2025

Gentian Diagnostics will also this year be present at EuroMedLab 2025 to promote our IVDR-certified automated cystatin C immunoassay. The assay can be applied to a wide range of clinical chemistry analysers, offering high inter-instrument accuracy for serum and plasma samples.

Since launching our assay in 2007, Gentian Diagnostics has become synonymous with cystatin C. The Gentian Cystatin C Immunoassay received FDA 510(k) clearance in 2008 and was instrumental in evaluating the commutability of the IFCC reference material (ERM-DA471/IFCC) in 2010.

Gentian Cystatin C Immunoassay:

• Particle-Enhanced Turbidimetric Immunoassay
• With avian antibodies for reduced interference 
• Can be applied on most automated platforms
• ERM-DA471/IFCC standardised
• CE-marked in compliance with IVDR 2017/746 (CE 0123)
• FDA 510(k) cleared
  
  
  

Kidney health advocates and organisations embrace the benefits of cystatin C

The clinical use of cystatin C is endorsed by KDIGO (Kidney Disease: Improving Global Outcomes) guidelines. In the United States, the National Kidney Foundation (NKF) and the American Society of Nephrology (ASN) also recommend the expanded use of cystatin C, alongside creatinine, to confirm eGFR and improve clinical decision-making, especially to address race disparities in Chronic Kidney Disease (CKD).

Both KDIGO and the NKF-ASN task force emphasise the importance of using the most accurate GFR assessment. They advocate for a combined use of cystatin C and creatinine to estimate GFR, providing a more precise evaluation when measured GFR (mGFR) is not available.

Also, the European Kidney Function Consortium (EKFC) has recently built on CKD-EPI’s work to eliminate race from eGFR equations. Using data from over 227,000 patients, they developed a cystatin C-based formula that excludes race and gender without sacrificing accuracy compared to creatinine-based methods.

Cystatin C advantages:

• Is independent of muscle mass^1-8
• Estimates GFR without race-adjustment⁹
• Correlates well with GFR within the “creatinine blind area”¹⁰
• Identifies CKD earlier than creatinine-based eGFR¹¹
• Helps dose medications with a narrow therapeutic index safely, whilst maintaining efficacy ^9,12
  
  

Contact us now for more information

Explore cystatin C in your lab - fill out the form or send an email to marketing@gentian.com for more information about the product and prices.

References: 

1. Dharnidharka VR et al. Serum cystatin C is superior to serum creatinine as a marker of kidney function: a meta-analysis. Am J Kidney Dis. 2002
2. 1–226.KDIGO Guidelines 2012 published in Kidney International Supplements Vol3 Issue 1, Jan 2013
3. NCIC Clinical guideline (CG182) updated jan 2015 section 2.1 https://www.nice.org.uk/guidance/cg182/chapter/2-Implementation-getting-started.
4. Tangri N et al. Changes in dietary protein intake has no effect on serum cystatin C levels independent of the glomerular filtration rate. Kidney Int. 2011
5. Grubb A. Cystatin C is Indispensable for Evaluation of Kidney Disease. EJIFCC. 2017
6. Björk J  et al. Validation of standardized creatinine and cystatin C GFR estimating equations in a large multicentre European cohort of children. Pediatr Nephrol. 2019
7. Inker LA  et al. Estimating glomerular filtration rate from serum creatinine and cystatin C [published correction appears in N Engl J Med. 2012
8. Schaeffner ES et al. Two novel equations to estimate kidney function in persons aged 70 years or older. Ann Intern Med. 2012
9. Ebert N, Shlipak MG. Cystatin C is ready for clinical use. Curr Opin Nephrol Hypertens. 2020
10. Lindström V. Low molecular mass proteins as markers for renal function and dialysis efficiency. Doctoral Dissertation, Lund University, 2013.
11. Murty MS et al. Serum cystatin C as a marker of renal function in detection of early acute kidney injury. Indian J Nephrol. 2013
12. Frazee E et al. Cystatin C-Guided Vancomycin Dosing in Critically Ill Patients: A Quality Improvement Project. Am J Kidney Dis. 2017
    
    

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