Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06379061
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-04-18
Brief Title:
Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts
Sponsor:
Beckman Coulter Inc
Organization:
Beckman Coulter Inc
Study Overview
Official Title:
Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts
Status:
RECRUITING
Status Verified Date:
2024-06
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:
The purpose of the pivotal study is to collect blood specimens and clinical data from pediatric 90 days old and adult 18 years old patients presenting with signs and symptoms suggestive of acute bacterial or viral infection These samples will be used to establish the diagnostic performance of MeMed BV for differentiating bacterial from viral infection using method comparison andor method concordance
Detailed Description:
The objective of this study is to collect blood specimens from pediatric 90 days old and adult patients 18 years old presenting with signs and symptoms suggestive of acute bacterial or viral infection from hospital Emergency Department or Urgent Care Centers for comparative testing on the Access 2 and DxI 9000 Immunoassay Analyzers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None