The U.S. Food and Drug Administration has approved the marketing of NephroCheck, the first test that can be used to asses a risk of developing acute kidney injury.
The test is capable of determining if certain critically ill hospitalized patients are at risk of developing moderate to severe acute kidney injury (AKI) in the 12 hours following the administration of the test. NephriCheck detects the presence of insulin-like growth-factor binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases (TIMP-2) in the urine, which are associated with acute kidney injury. It can provide a score based on the amount of the proteins present that correlates to the patient's risk of developing AKI within 12 hours of the test being performed in 20 minutes.
"Early assessment and timely treatment for AKI can help prevent kidney damage and potential associated complications," Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health, said in a press statement. "The NephroCheck provides health care providers with a quick, validated method of assessing a patient's AKI risk status which may inform patient management decisions."
The effectiveness and safety of the test was reviewed in two clinical trials, which compared the clinical diagnoses of more than 500 critically ill subjects at 23 hospitals. The researchers noted that NephroCheck was able to accurately detect 92 percent of AKI patients in one study and 76 percent in the other.
AKI includes the sudden decline of kidney functions, without any prior symptoms. This usually follows an injury to the kidney, which may be caused due to an existing disease or infection. The consequences of this condition include fluid build-up in the body, chest pain, muscle weakness and permanent kidney damage or chronic kidney disease. A 2012 report suggested that severe acute kidney injuries are becoming more common in the United States, rising 10 percent per year and doubling over the last decade.
"That was a staggering revelation of how increasingly common and how life-threatening acute kidney injury has become over the past decade in the United States," Dr. Raymond K. Hsu, a UCSF nephrologist who led the research, said in the press statement. "We hope that clinicians, researchers and the general public can gain a higher appreciation of the devastating impact of acute kidney injury that is comparable to the near universal, basic understanding of other forms of acute organ injury, such as heart attack and stroke."