CLIA Cystatin C

Description

Cystatin C is a small protein ubiquitously expressed at a constant rate and freely filtered by the glomerulus. The CKD-EPI cystatin C equation demonstrated a good correlation with measured GFR in patients with all common causes of kidney disease, including kidney transplant recipients. Cystatin C estimated GFR (eGFR) may have advantages over creatinine eGFR in certain patient groups in whom muscle mass is abnormally high or low. Currently, cystatin C is a biomarker recommended by NICE and KDIGO guidelines for the diagnosis and treatment of CKD.

Chronic Kidney Disease Chronic kidney disease has become a global health burden. The modern classification of kidney function is based on eGFR, which classifies CKD into five stages. In clinical routine, serum creatinine is an established screening test of kidney function, but it is insensitive to small changes in GFR and fails to detect an early decline in a patient’s glomerular filtration rate. Up to 50 % of kidney function can be lost before significant Creatinine levels become detectable. KDIGO and NICE recommend cystatin C to diagnose patients in the CKD stage 2 and 3 correctly.

Acute Kidney Injury Blood levels of cystatin C also equilibrate more quickly than creatinine, and therefore, serum cystatin C may be more accurate than serum creatinine when kidney function is rapidly changing. Therefore, Cystatin C is a more sensitive marker for AKI compared to Creatinine and Cystatin C does not have a blind area.

Technical data

• Assay time: 15 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: 5-80 ng/ml
• Complementary products: Dilution Cartridge 1 (catalog number: CL-DIC1) , Anchor® Tips, Stackable Cuvette, KleeYa Trigger Pack, KleeYa Wash buffer
• Note: Please note: To dilute samples in chemiluminescent analysis with the CLIA Cystatin C kit, please exclusively order Dilution Cartridge 1 (catalog number: CL-DIC1) from your sales manager. The kits are CE-IVD certified and intended for professional use.

Specifications

• Catalog Number: CL-CysC100
• Size: 100 tests
• Regulatory status: CE IVD
• Clinical topic: Renal Diseases
• Producer: TestLine Clinical Diagnostics s.r.o.

References

• 11978596,22762315,12578517,33044285,30622984,23701892
• Laterza OF, Price CP, Scott MG. Cystatin C: an improved estimator of glomerular filtration rate? Clin Chem. 2002 May;48(5):699-707. PMID: 11978596.
• Inker LA, Schmid CH, Tighiouart H, Eckfeldt JH, Feldman HI, Greene T, Kusek JW, Manzi J, Van Lente F, Zhang YL, Coresh J, Levey AS; CKD-EPI Investigators. Estimating glomerular filtration rate from serum creatinine and cystatin C. N Engl J Med. 2012 Jul 5;367(1):20-9. doi: 10.1056/NEJMoa1114248. Erratum in: N Engl J Med. 2012 Aug 16;367(7):681. Erratum in: N Engl J Med. 2012 Nov 22;367(21):2060. PMID: 22762315; PMCID: PMC4398023.
• Swedko PJ, Clark HD, Paramsothy K, Akbari A. Serum creatinine is an inadequate screening test for renal failure in elderly patients. Arch Intern Med. 2003 Feb 10;163(3):356-60. doi: 10.1001/archinte.163.3.356. PMID: 12578517.
• Sangla F, Marti PE, Verissimo T, Pugin J, de Seigneux S, Legouis D. Measured and Estimated Glomerular Filtration Rate in the ICU: A Prospective Study. Crit Care Med. 2020 Dec;48(12):e1232-e1241. doi: 10.1097/CCM.0000000000004650. PMID: 33044285.
• Larki RA, Jamali B, Meidani M, Mousavi S. Serum Cystatin C for Evaluation of Acute Kidney Injury in Adults Treated with Colistin. J Res Pharm Pract. 2018 Oct-Dec;7(4):178-181. doi: 10.4103/jrpp.JRPP_18_53. PMID: 30622984; PMCID: PMC6298137.
• Shlipak MG, Mattes MD, Peralta CA. Update on cystatin C: incorporation into clinical practice. Am J Kidney Dis. 2013 Sep;62(3):595-603. doi: 10.1053/j.ajkd.2013.03.027. Epub 2013 May 20. PMID: 23701892; PMCID: PMC3755100.

• Reagent Cartridge with specific reagents for the assay
• magnetic particles
• calibrators