NephroCheck test kit, distributed by Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics, Raritan, NJ, has announced the availability of the NephroCheck test system, the first of its kind to receive FDA approval for assessment of acute kidney injury (AKI).

AKI is a common and potentially fatal condition in which the kidneys suddenly cease to function as a result of sepsis, pneumonia, major or cardiac surgery, or drugs toxic to the kidneys. Compared to patients without AKI, patients with AKI require double the length of stay in hospital and intensive care units, and the death rates one year later for patients with AKI alone are higher than for patients with heart attack alone.

The NephroCheck test system is designed to help healthcare providers identify patients at risk of developing moderate or severe AKI within the next 12 hours. Using a patient’s urine sample, the system detects the presence of insulin-like growth-factor binding protein 7 (IGFBP-7) and tissue inhibitor of metalloproteinases (TIMP-2), which are associated with AKI, and within 20 minutes provides a score that indicates the patient’s likelihood of developing AKI. Patients with a positive NephroCheck AKIRisk score (greater than the cutoff of 0.3) have a 25% to 33% chance of developing moderate or severe AKI within 12 hours of assessment.

“The availability of a test to identify patients at risk of developing moderate to severe acute kidney injury can allow for the recognition and closer management of these patients,” says Kianoush Kashani, MD, of the Mayo Clinic. “A test designed to achieve high sensitivity, such as the NephroCheck test, allows for the identification of the majority of patients at risk for developing moderate to severe acute kidney injury.”

If untreated, AKI can cause irreversible kidney damage. The condition generally lacks any signs or symptoms.

In July 2014, Ortho-Clinical Diagnostics entered into a strategic collaboration with Astute Medical Inc, the developer of the NephroCheck test system, to become the exclusive sales agent for the NephroCheck test and the Astute140 meter in the United States and in certain countries of the European Union.

“NephroCheck provides customers with a simple, yet innovative new approach to help healthcare providers assess the risk of acute kidney injury, which leads to poor patient outcomes and increased hospital costs,” says Robert Yates, COO at Ortho-Clinical Diagnostics. “Ortho-Clinical Diagnostics is focused on bringing targeted solutions to our customer that address unmet clinical needs and drive improvements to quality care.”

For more information, visit Ortho-Clinical Diagnostics.