Rapid Urine Test Detects Early Kidney Injury

A new test utilizes fluorescence immunoassay technology to detect and measure two biomarkers that reflect the risk of developing acute kidney injury (AKI).

The NephroCheck Test measures tissue inhibitor of metalloproteinase 2 (TIMP-2) and insulin-like growth factor binding protein 7(IGFBP-7) in human urine. Both are involved in G1 cell cycle arrest during the very early phases of cellular stress, and are robust measures of risk for AKI manifesting within the following 12-24 hours. TIMP-2 is an inhibitor of the matrix metalloproteinases (MMPs) that directly suppress the proliferation of endothelial cells. IGFBP-7 is involved in the regulation of tissue availability of insulin and IGFs, and stimulates cell adhesion implicated in epithelial cell-cycle arrest.


For the test, a sample of a patient’s urine is mixed with reagents onto a single-use cartridge inserted into the proprietary Astute140 Meter. The meter employs a sandwich immunoassay technique along with fluorescence detection technology to quantitatively measure the biomarker concentrations, combining them into a single numerical test result. Multiple levels of controls (internal, external, and electronic) are used to ensure reliable and accurate results in about 20 minutes. The NephroCheck Test and Astute140 Meter are products of Astute Medical (San Diego, CA, USA), and have received the European Community CE marking of approval.

“We believe the NephroCheck Test will be able to help physicians address one of the most costly, deadly, and confounding conditions affecting intensive care hospital patients,” said Chris Hibberd, CEO of Astute Medical. “With increasing constraints on healthcare spending, innovative tools such as the NephroCheck Test will be essential to ensuring that the right resources get to the right patients at the right time.”

AKI is a significant global health hazard that strikes up to seven percent of hospitalized patients. AKI often occurs in patients that are already suffering from myriad issues such as sepsis, trauma, surgery, or being treated with nephrotoxic drugs, further complicating diagnosis, while also increasing mortality rates.

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