Ignite Creation Date:
2024-05-06 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05271617
Status:
COMPLETED
Last Update Posted:
2023-09-11
First Post:
2022-02-28
Brief Title:
VIDAS Nephroclear NCL CCL14 - Sample Stability
Sponsor:
BioMérieux
Organization:
BioMérieux
Study Overview
Official Title:
VIDAS Nephroclear CCL14 Sample Stability Study
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 NEPHROCLEARCCL14 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 02 ngmL to 30 ngmL 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
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 NEPHROCLEARCCL14 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 02 ngmL to 30 ngmL 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None