Ortho Clinical launches new test to predict AKI in Europe

7 June 2017 (Last Updated June 7th, 2017 18:30)

US-based in-vitro diagnostics company Ortho Clinical Diagnostics has launched the new VITROS NephroCheck test to predict acute kidney injury (AKI) in Europe.

US-based in-vitro diagnostics company Ortho Clinical Diagnostics has launched the new VITROS NephroCheck test to predict acute kidney injury (AKI) in Europe.

The CE marked test is designed as an automated risk assessment tool for AKI prediction.

NephroCheck is a simple urine test that can deliver results in 16 minutes, while it enables clinicians to predict the risk of AKI and proactively treat the patients.

Unlike the new test, the existing indicator tools such as serum creatinine and urine output are said to be capable of detecting AKI only after kidney damage has occurred.

The test is compatible with the Astute 140 metre and the firm’s fully automated VITROS 3600/5600 immunodiagnostic systems.

"NephroCheck is a simple urine test that can deliver results in 16 minutes, while it enables clinicians to predict the risk of AKI and proactively treat the patients."

Ortho Clinical Diagnostics chief operating officer Robert Yates said: "The first of its kind, the VITROS NephroCheck test provides a quick and effective way for doctors to assess which patients are at risk for AKI before kidney damage occurs.

“A significant milestone in the expansion of Ortho's menu, this test is integrated into existing VITROS systems, which maximises lab investments, efficiency and output. It provides both clinical and economic value."

Developed under licence from Astute Medical, the nature of the test as an AKI risk assessment tool was validated in two international clinical trials with a total of more than 1,200 subjects at 29 sites.

NephroCheck is claimed to accurately measure the TIMP-2 and IGFB-7 biomarkers for kidney stress.

The test features technologies such as Intellicheck to monitor, verify and document diagnostic checks, and MicroSensor to detect endogenous interferences. It also includes a combination of MicroWell and the Enhanced Chemiluminescence Detection technology to improve signal detection, as well as VersaTip to avoid carryover and cross-contamination.