FDA Approves Marketing of Lab Test for Acute Kidney Injury Risk

The NephroCheck test can determine whether certain critically ill, hospitalized patients are at risk of developing moderate to severe acute kidney injury in the 12 hours following the administration of the test.

The U.S. Food and Drug Administration has approved for marketing the NephroCheck test, a laboratory test that can determine whether certain critically ill, hospitalized patients are at risk of developing moderate to severe acute kidney injury in the 12 hours following the administration of the test. "Early knowledge that a patient is likely to develop AKI may prompt closer patient monitoring and help prevent permanent kidney damage or death," according to the agency's Sept. 5 news release.

"AKI is a sudden decline in kidney function, often without early signs or symptoms, following an injury to the kidney caused by a co-existing disease, infection, or other condition. AKI can cause fluid to build up in the body, chest pain, muscle weakness, and permanent kidney damage or chronic kidney disease (the gradual loss of kidney function). Critically ill patients are the most at risk for AKI, particularly patients who meet certain factors such as advanced age, diabetes and high blood pressure," the release states. "Current laboratory tests can only assess whether a patient may already have AKI; often, the patient has progressed to moderate to severe AKI before the test results confirm the clinical diagnosis. NephroCheck 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. Within 20 minutes, the test provides 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. No other tests currently on the market are FDA-approved or cleared to assess the risk of developing AKI in at-risk patients."

"Early assessment and timely treatment for AKI can help prevent kidney damage and potential associated complications," said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at FDA's Center for Devices and Radiological Health. "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 NephroCheck Test System is manufactured by Astute Medical based in San Diego, Calif.

Download Center

  • Lone Worker Safety Guide

    As organizations digitalize and remote operations become more commonplace, the number of lone workers is on the rise. These employees are at increased risk for unaddressed workplace accidents or emergencies. This guide was created to help employers better understand common lone worker risks and solutions for lone worker risk mitigation and incident prevention.

  • Online Safety Training Buyer's Guide

    Use this handy buyer's guide to learn the basics of selecting online safety training and how to use it at your workplace.

  • COVID Return-to-Work Checklist, Fall 2021

    Use this checklist as an aid to help your organization return to work during the COVID-19 pandemic in a safe and healthy manner.

  • SDS Buyer's Guide

    Learn to make informed decisions while searching for SDS Management Software.

  • Risk Matrix Guide

    Risk matrices come in many different shapes and sizes. Understanding the components of a risk matrix will allow you and your organization to manage risk effectively.

  • Industry Safe

Featured Whitepapers

OH&S Digital Edition

  • OHS Magazine Digital Edition - October 2021

    October 2021

    Featuring:

    • TRAINING
      On Route To Safe Material Handling
    • SAFETY CULTURE
      Normalization of Deviations in Performance
    • IH:INDOOR AIR QUALITY
      Arresting Fugitive Dusts
    • PPE:FOOT PROTECTION
      Safety Shoes Make the Outfit for Well-Protected Workers
    View This Issue