Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-28 @ 10:57 PM
Study NCT ID:
NCT03037957
Status:
COMPLETED
Last Update Posted:
2017-07-07
First Post:
2017-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients
Sponsor:
Luminex Corporation
Organization:
Study Overview
Official Title:
A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients
Status:
COMPLETED
Status Verified Date:
2017-07
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:
A multi-center evaluation to assess the diagnostic sensitivity and specificity of the ARIES Group A Strep Assay will be established through a method comparison using prospectively collected, de-identified, clinical samples collected during the enrollment period.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: