VIDAS® NEPHROCHECK® Performance Evaluation
Research type
Research Study
Full title
Method comparison of VIDAS® NEPHROCHECK® and NEPHROCHECK® Assays Using Patient Samples
IRAS ID
270967
Contact name
Marlies Ostermann
Contact email
Sponsor organisation
bioMérieux SA
Duration of Study in the UK
0 years, 4 months, 31 days
Research summary
Summary of Research\n\nAcute kidney injury (AKI), also called acute kidney failure is a serious problem when patients are critically ill. It affects more than half of the patients in the Critical Care Unit. Patients who get AKI spend a longer time in hospital, and have a higher risk of dying and a higher risk of needing long-term dialysis. \nIt is very important to diagnose AKI as early as possible so that the condition can be reversed. In the last few years, it has been shown that new tests, also called biomarkers, can identify AKI earlier than routinely used tests. One of these tests is “Nephrocheck” which measures 2 specific proteins in the urine (TIMP-2 and IGFBP7). There are two European sites involved in the patient recruitment of this study (Edouard Herriot Hospital in France and Guys and St Thomas Hospital, London). The test is already in use at Guy’s & St Thomas Hospital, London. \nIn this research study, we would like to compare the performance of the current Nephrocheck Analyser with that of the VIDAS® NEPHROCHECK® analyser. With informed consent, we will analyse urine samples of patients in the Intensive Care Unit or Coronary Care Unit with both analysers. The aim is to find out whether the results are similar with both analysers. There will be no change in treatment for the patients.\n\nSummary of Results\n\nA method comparison study was performed between the VIDAS® NEPHROCHECK® assay and the NEPHROCHECK® Test. The objective was to compare the performance of the 2 tests in terms of quantitatively determining the concentration of TIMP-2 and IGFBP7 analytes.\n\nThe trial population was recruited at two (2) external sites, one in France and one in the United Kingdom (UK), and tested on one internal (bioMérieux Clinical Affairs laboratory) and one external (UK) sites. Samples consisted of prospective fresh and frozen left over urine samples from the intended use population. \n\nThe patients included in this clinical study were adult acutely ill patients (>18 years). The appropriate regression analysis was performed between the 2 tests over the measuring interval. The obtained slope of the regression analysis met the acceptance criteria defined in the protocol and confirmed the acceptable results of VIDAS® NEPHROCHECK® assay. \n
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
19/SC/0522
Date of REC Opinion
9 Jan 2020
REC opinion
Further Information Favourable Opinion