Cystatin C PETIA is FDA 510(k) cleared. For in vitro Diagnostic Use in the US.
Health Canada License: 80727.
Particle enhanced turbidimetric immunoassay (PETIA)
Glomerular filtration rate (GFR)
Various methods based on Creatinine are being widely used to assess the GFR. However, all of them often lead to over or under estimation of the GFR and thus has to be adjusted by various factors including age, gender, diet, muscle mass and race. Unlike creatinine serum cystatin C is virtually unaffected by these factors and very simple formulas can be used to obtain a reliably estimated GFR.
A number of well documented studies comparing creatinine or creatinine based GFR estimations and cystatin C have shown cystatin C to be superior to creatinine. In particular, creatinine based assesments of GFR have a lack of sensitivity until stage 2 and 3 of renal disease. Cystatin C does not have this “blind area”, thus GFR changes can be detected earlier when intervention might improve outcomes. Cystatin C values are already elevated when creatinine is still within the normal range.
A cystatin C based GFR calculation can directly be performed on www.gfrcalc.com
For further information see Dossier: Chronic Kidney Disease
|Time to result||10 min (approx.)|
|Sample type||2 µl plasma, serum|
|Dynamic range||0.25-8.0 mg/ml|
|Catalog Number||see below|
|Status||FDA 510(k) cleared, IVD|