NCT05271617

VIDAS Nephroclear (NCL) CCL14 - Sample Stability

VIDAS Nephroclear CCL14 : Sample Stability Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: BioMérieux · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This VIDAS® NEPHROCLEAR™ CCL14 (VIDAS® NCL™ CCL14) Sample Stability clinical trial is a multicenter, prospective, and qualitative study. The main study objective is to determine sample stability conditions for the VIDAS® NEPHROCLEAR™ CCL14 Test. This 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.

Detailed description

Product name and intended use 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. Product description The VIDAS® NEPHROCLEAR™ CCL14 Test is an automated assay for use on the VIDAS® 3 instrument for the immunoenzymatic quantitative determination of C-C motif chemokine ligand 14 (CCL14) protein in human urine using the Enzyme Linked Fluorescent Assay (ELFA) technique. Trial Design Overview This VIDAS® NEPHROCLEAR™CCL14 (VIDAS® NCL™ CCL14) clinical trial is a multicenter, prospective, and qualitative study. 40 to 80 samples collected and tested from subjects enrolled in a related trial will also be tested on the VIDAS® 3 instrument and test. Trial objectives The objective of this trial is to identify suitable storage conditions for samples tested using the VIDAS® NCL™ CCL14 for the full measuring range of the assay (0.2 ng/mL to 30 ng/mL). To this end, samples will be tested under the following conditions: * Fresh, and tested within approximately 2 hours of collection, * After one freeze-thaw cycle, * After two freeze-thaw cycles, * After storage at ambient temperature for approximately 5 hours (tested 5 to 7 hours from collection time), and * After storage at 2 - 8 ºC for approximately 24 hours (tested 24 to 26 hours from collection time) Samples collected from at least 40 subjects with urine CCL14 levels spanning the assay measuring range will be analyzed among these conditions.

Conditions

• Acute Kidney Injury

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	VIDAS® NEPHROCLEAR™ CCL14	Measurement of CCL14 in sample aliquots after being subjected to different testing conditions

Timeline

• Start date: 2022-03-10
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2022-03-09
• Last updated: 2023-09-11

Locations

1 site across 1 country: United States