Tina-quant® Cystatin C

Supporting the early detection of chronic kidney disease

Tina-quant® Cystatin C

Supporting the early detection of chronic kidney disease

 

Kidney disease has a major effect on global health, both as a direct cause of global morbidity and mortality and as an important risk factor for cardiovascular disease.

Globally, in 2017, 1·2 million people died from CKD. The global all-age mortality rate from CKD increased 41·5% between 1990 and 2017, although there was no significant change in the age-standardised mortality rate.1

Cystatin C, has been shown to be subject to less biological interference and more sensitive to early declines in kidney function, than endogenous serum biomarkers such as albumin and creatinine.2

Cystatin C

Determination of subtle changes in GFR is crucial in the early detection of CKD

 

Serum creatinine levels only begin to rise in CKD stage 3 when approximately 50 % of renal function is already lost (“creatinine-blind area”). Subtle changes in the GFR in

CKD stages 1 and 2 – not detectable by creatinine-based measurements – can be determined by cystatin C due to its higher sensitivity and specificity.

Figure 1: Stages of chronic kidney disease according to NKF KDOQI4

Cystatin C graph 1

Highly sensitive and specific, unaffected by physical factors

 

Cystatin C is not affected by any physical factors such as muscle mass, age, gender or ethnicity. As a result, cystatin C shows a relatively high diagnostic sensitivity and specificity compared with creatinine, making it a reliable early marker of renal dysfunction. In a study of 93,000 patients, cystatin C-based estimation of GFR, correctly reclassified 42 % of patients with a creatinine-based estimation of GFR of 45 - 59 mL/min/1.73 to a “normal” risk group concerning end-stage renal disease and cardiovascular death.5

Figure 2: ROC analysis of cystatin C and creatinine3

Cystatin C graph 2

Tina-quant Cystatin C Gen.2 – excellent assay performance

 

Figure 3: Correlation between cobas c 501 and Siemens BN II cystatin C application. Highly developed turbidimetric detection technology delivers accurate results comparable to nephelometric measurement methods.6

Cystatin C graph 3

  1. Lancet 2020; 395: 709–33
  2. J Clin Pharmacol2018 Oct;58(10):1239-1247
  3. Artunc, F., Fischer, I.U., Risler, T., Erley, C.M. (2005). Improved estimation of GFR by serum cystatin C in patients undergoing cardiac catherization. Int J Cardiol 102, 173-8.
  4. National Kidney Foundation Kidney Disease Outcomes Quality Initiative, www.kidney.org/professionals/kdoqi/.
  5. Cystatin C versus Creatinine in Determining Risk Based on Kidney Function Michael G. Shlipak, et al, N Engl J Med 2013; 369:932-43.
  6. Data on file at Roche (2011). Lotz J., Trummler M., Esmilaire L. Correlation study turbidimetry versus nephelometry. Turbidimetry setting new standards: Consolidation without compromise.