New Assay Allows Earlier Diagnosis of Impaired Renal Function

Roche is pleased to announce the launch of a new assay for the early assessment of glomerular filtration rate (GFR) in patients with impaired renal function. The Roche Cystatin C assay is more sensitive than creatinine measurements, allowing diagnosis of chronic kidney disease (CKD) at an early stage when therapeutic intervention is possible. Cystatin C is an endogenous substance synthesised by all nucleated cells at a constant rate and filtered freely by the glomerulus. Unlike creatinine, cystatin C levels are not affected by muscle mass, age (below 50), gender or inflammation and it is only eliminated via filtration, making it a convenient and accurate marker for the assessment of GFR.

Studies have suggested that Cystatin C is a more sensitive marker of GFR than creatinine1,2,3. By indicating a reduction in GFR sooner, it is ideal for the assessment of patients in the early stages of CKD and reduces the need to perform invasive determinations of GFR. The Roche Cystatin C assay is promoted for use in the assessment of children (under 4) and patients under the age of 60, for early diagnosis of initially minor kidney damage (for example in diabetes patients). It can also be used in monitoring kidney disease and post transplantation patients, and for dose adjustment of renally excreted drugs. The assay is easy to use, requiring minimal handling, and produces highly precise and sensitive results from a low sample volume (2μl).