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FRIDAY, Sept. 5, 2014 (HealthDay News) -- The NephroCheck test, designed to predict the risk of sudden kidney injury within 12 hours, has been approved by the U.S. Food and Drug Administration.
Current tests can only determine whether critically ill people already have an acute kidney injury, the agency said Friday in a news release. The new test, if it determines a near-term acute kidney injury is likely, can prompt closer monitoring and help prevent permanent kidney damage, the FDA said.
The kidneys remove waste from the body. When they don't work properly, waste can gather and lead to serious health problems.
The new test was evaluated in two clinical studies involving more than 500 critically ill people at 23 hospitals. It accurately predicted 92 percent of acute kidney injury cases in one study and 76 percent in the other, although it also incorrectly gave a positive result in about half of people without acute kidney injury, the FDA said.
The NephroCheck test system is produced by Astute Medical, based in San Diego.
-- Scott Roberts
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