VIDAS® NEPHROCLEAR Diagnostic Accuracy Study

Status Completed

Clinical Trial Summary

This is a multi-center sample analysis study in which urine samples previously collected from persons with Stage 2 or Stage 3 Acute Kidney Injury (AKI), will be tested in order to validate the VIDAS® NEPHROCLEAR™ CCL14 Test

Clinical Trial Description

The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in conjunction with clinical evaluation, in ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI), as an aid in the risk assessment for developing persistent severe AKI (stage 3 AKI lasting ≥ 72 hours) within 48 hours of patient assessment. The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in patients 21 years of age or older. The objective of this study is to evaluate the diagnostic accuracy of the VIDAS® NEPHROCLEAR™ CCL14 test when used on the VIDAS® 3 instrument. Sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), likelihood ratios (LR), and relative risk (RR), will be evaluated at the pre-determined cut-off values. Previously collected urine samples from persons with Stage 2 to Stage 3 AKI will be tested in this study. The VIDAS® test results will be compared to the clinical AKI status established by independent adjudication by medical professionals, that are blinded to the VIDAS® test results. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06036758
Study type	Observational
Source	BioMérieux
Contact
Status	Completed
Phase
Start date	July 17, 2023
Completion date	December 28, 2023

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