VIDAS

B3166 VIDAS® NEPHROCLEAR™ CCL14

Reference Number 423961

Protocol Number: B3166

Protocol Version: Revision 4

Version Date: 06 Sep 2022

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Study Investigators

• PI: Danielle Davison, MD
• Sub-I: Katrina Hawkins, MD
• Sub-I: Lynn Abell, MD
• Sub-I: Mustafa Al-Mashat, MD
• Sub-I: Yoosif Abdalla, MD

Study Objectives

The objective of this trial is to identify suitable storage conditions for samples tested using the VIDAS® NCLTM CCL14 test for the full measuring range of the assay (0.2 ng/mL to 30 ng/mL).

Patient Population

See inclusion criteria below.

Inclusion Criteria

This study will utilize samples that have been collected from individuals who have consented to the use of samples in the AST-134 study and related studies such as the VIDAS® NCLTM CCL14 trial.

• 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
• Written 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