Enzymatic Kit Determines Creatinine in Serum and Urine

A low-cost enzymatic kit determines the quantity of creatinine in serum and urine samples.

The method is a liquid stable, two-reagent system, which uses coupled enzyme reactions that are more specific and sensitive than conventional non-enzymatic methods. The assay features a reduced sample size requirement that is ideal for neonatal testing with specimen requirements as low as 4-8 µl per test. The method also provides an improved interference profile with no significant interferences from bilirubin to 16 mg/dl, hemoglobin to 200 mg/dl, triglycerides to 1000 mg/dl, and ascorbic acid to 50 mg/dl.

The assay, developed by Diazyme Laboratories (La Jolla, CA, USA), is noncaustic, nonstaining, and has no costly hazardous shipping requirements. Instrument parameters are available for a wide array of analyzers with a choice of packaging formats suitable for use in laboratories of all volumes and workflows. In comparison, the colorimetric Jaffe methods for creatinine are caustic (picric acid) and can stain analyzer tubing and cuvette, as well as giving a 20% false elevation of creatinine at the low creatinine concentration range.

Diazyme uses its platform enzyme technologies including enzyme cycling, substrate-trapping-enzyme (STE), and allosteric enzyme-coupled immunoassay (AECIA), to develop low cost and uniform diagnostic products for clinical and research use.

The U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its enzymatic creatinine assay kit.


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Diazyme Laboratories