Novel Biomarker Detection Process
After the user inserts the NephroCheck® Test cartridge, the Astute140® Meter converts the fluorescent signals for the individual immunoassays—the specific novel biomarkers—into concentrations, combining them into a single numerical test result. The NephroCheck® Test and Astute140™ Meter employ a sandwich immunoassay technique along with fluorescence detection technology to quantitatively measure biomarkers of acute kidney injury in human urine samples. Multiple levels of controls (internal, external and electronic) ensure reliable and accurate test results.
The NephroCheck Test® result is intended as an aid in the risk assessment of acute kidney injury in the critically ill. The NephroCheck® Test results should be evaluated in the context of all clinical and laboratory data available.
The NephroCheck® Test and the Astute140® Meter are CE marked.
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