Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 5:20 AM
Study NCT ID:
NCT04981769
Status:
UNKNOWN
Last Update Posted:
2021-07-29
First Post:
2021-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
POC SARS-CoV-2 Diagnostic PCR Device Comparison to FDA Approved Reference PCR Test
Sponsor:
Anavasi Diagnostics
Organization:
Study Overview
Official Title:
POC SARS-CoV-2 Diagnostic PCR Device Comparison to FDA Approved Reference PCR Test
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
NOT_YET_RECRUITING
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:
Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites.
Detailed Description:
Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites using a national laboratory PCR Covid-19 test as reference. This study is following FDA EUA molecular test approval criteria. Study will be conducted in 3 or more geographically diverse clinical sites.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: