VIDAS® NEPHROCLEAR Diagnostic Accuracy Study

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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VIDAS® NEPHROCLEAR CCL14 Diagnostic Accuracy Study

Conditions
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Acute Kidney Injury, Stage 2 Acute Kidney Injury, Stage 3 Acute Kidney Injury

Intervention / Treatment
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* Diagnostic Test: VIDAS® NEPHROCLEAR™ CCL14 Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a) Males and females 21 years of age or older; b) Receiving care in an intensive care unit; c) Expected to remain in the ICU for at least 48 hours after enrollment; d) Use of indwelling urinary catheter as standard care at the time of enrollment; e) Subject must have acute kidney injury (KDIGO Stage 2 or Stage 3) at the time of sample collection; f) Urine sample must be collected within 36 hours of meeting KDIGO Stage 2 criteria; g) Documented informed consent provided by patient or legally authorized representative (LAR). Exclusion Criteria: a) Prior kidney transplantation; b) Comfort-measures-only status; c) Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment; d) Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic); (NOTE: HIV or hepatitis testing need not be performed for enrollment in this study.) e) Special populations, pregnant women, prisoners or institutionalized individuals;

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Persons with Stage 2 to Stage 3 AKI<br>Persons with Stage 2 to Stage 3 AKI who are in the ICU. | Diagnostic Test: VIDAS® NEPHROCLEAR™ CCL14 Test<br>* Urine samples previously collected from persons with stage 2/stage 3 AKI will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of developing persistent severe AKI | The urine sample collected from ICU patients will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test, which 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 | Within 48 hours of ICU admittance |