VIDAS® NEPHROCLEAR Diagnostic Accuracy Study

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.

Inclusion criteria

• Males and females 21 years of age or older;
• Receiving care in an intensive care unit;
• Expected to remain in the ICU for at least 48 hours after enrollment;
• Use of indwelling urinary catheter as standard care at the time of enrollment;
• Subject must have acute kidney injury (KDIGO Stage 2 or Stage 3) at the time of sample collection;
• Urine sample must be collected within 36 hours of meeting KDIGO Stage 2 criteria;
• Documented informed consent provided by patient or legally authorized representative (LAR).

Exclusion criteria

• Prior kidney transplantation;
• Comfort-measures-only status;
• Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment;
• 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.)
• Special populations, pregnant women, prisoners or institutionalized individuals;