What is the role of NephroCheck in the workup of acute kidney injury (AKI)?

Updated: Dec 24, 2020
  • Author: Biruh T Workeneh, MD, PhD, FASN; Chief Editor: Vecihi Batuman, MD, FASN  more...
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Answer

In September 2014 the US Food and Drug Administration (FDA) approved NephroCheck, the first laboratory test to evaluate the risk of developing moderate to severe AKI in hospitalized, critically ill patients. The test identifies the presence of two AKI-associated proteins (insulinlike growth-factor binding protein 7, tissue inhibitor of metalloproteinases) in urine. Based on the level of these proteins, a score is derived that indicates the likelihood that a patient will develop AKI within the next 12 hours. [47]

Approval for NephroCheck was based on two studies, which compared results from the test with the clinical diagnosis of over 500 critically ill patients. In patients with AKI, NephroCheck was 92% accurate in detecting the condition in one study and 76% accurate in the other. In both studies, however, the test reported false-positives in about 50% of patients without AKI.


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