NephroCheck Test Gauges Risk for AKI

The NephroCheck test system is now being marketed by Ortho Clinical Diagnostics to help identify risk of acute kidney injury (AKI). The urine test is designed to detect both insulin-like growth factor binding protein 7 and tissue inhibitor of metalloproteinases, factors associated with AKI.

The test provides a score within 20 minutes that shows a patient’s risk for the development of AKI, Ortho noted in an announcement. Patients with a positive NephroCheck risk (greater than the defined cutoff point of 0.3) have a one-in-four to a one-in-three chance of developing moderate or severe AKI within 12 hours of assessment, Ortho reported.

The U.S. Food and Drug Administration (FDA) approved the test, manufactured by Astute Medical, in September 2014.

The test has shown that it gives a positive result in about half of patients who do not have AKI, according to Medscape. Two studies compared NephroCheck results with the diagnoses in more than 500 critically ill patients at 23 hospitals; the test accurately detected 92 percent of AKI patients in one study and 76 percent in the other.

The test system may be used along with clinical evaluation in intensive care unit patients who currently have or have had within the preceding 24 hours an acute cardiovascular event, respiratory compromise, or both. The test should be used as an aid in the risk assessment for moderate or severe AKI within 12 hours of patient assessment in patients over age 21.

For more information about the product, visit