ADLM 2026: Beyond creatinine - Why leading labs are adding cystatin C

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

Since launching our assay in 2006, Gentian Diagnostics has become synonymous with cystatin C. The Gentian Cystatin C Immunoassay received FDA 510(k) clearance in 2007 and was instrumental in evaluating the commutability of the IFCC reference material (ERM-DA471/IFCC) in 2010.

Why labs are implementing cystatin C now:

• Increasing guideline alignment

• Growing demand for equitable diagnostics

• Need for improved precision in complex patients

• Easy integration into existing lab workflows

Gentian Cystatin C Immunoassay

Designed for seamless implementation across routine chemistry platforms:

• Particle-Enhanced Turbidimetric Immunoassay
• With avian antibodies for reduced interference 
• Broad analyser compatibility
• ERM-DA471/IFCC standardized
• FDA 510(k) cleared since 2007
• CE-marked in compliance with IVDR 2017/746 (CE 0123)

Clinical relevance: Why cystatin C is gaining momentum

Kidney health advocates and organizations embrace the benefits of cystatin C

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 CKD. Recent guidance from the US Department of Veterans Affairs (2025) reinforces this direction, recommending cystatin C to improve risk stratification and support clinical decision-making in patients with or at risk of chronic kidney disease.

Together, these recommendations emphasize a clear shift toward combining cystatin C with creatinine when measured GFR (mGFR) is not available — driving increasing demand for implementation in routine laboratory testing.

Cystatin C advantages:

• Is independent of muscle mass → more reliable across patient groups^1-8
• Estimates GFR without race-adjustment⁹
• Correlates well with GFR within the “creatinine blind area”¹⁰
• Identifies chronic kidney disease (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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