Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360757
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-04-02
Brief Title:
Clinical Evaluation of the NeuMoDx SARS-CoV-2 Assay COVID-19
Sponsor:
QIAGEN Gaithersburg Inc
Organization:
QIAGEN Gaithersburg Inc
Study Overview
Official Title:
Multi-Center Clinical Performance Evaluation of the NeuMoDx SARS-CoV-2 Assay on the NeuMoDx Molecular Systems
Status:
RECRUITING
Status Verified Date:
2024-04
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 multicenter study using prospectively collected fresh Category I and frozen Category II residualleftover nasopharyngeal NP swab in UTMUVT specimens obtained from symptomatic individuals suspected of COVID-19 infection This study will evaluate the NeuMoDx SARS-CoV-2 Assays clinical performance on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems
Detailed Description:
None
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