Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04690413
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2020-08-31
Brief Title:
NOWDx Test for the Detection of Antibodies to COVID-19
Sponsor:
NOWDiagnostics Inc
Organization:
NOWDiagnostics Inc
Study Overview
Official Title:
NOWDx Test for the Detection of Antibodies to COVID-19
Status:
COMPLETED
Status Verified Date:
2022-10
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 study is designed to compare the performance of the NOWDx COVID-19 Test to an emergency use authorized PCR test result The intent is to show the rapid test device is comparable to a currently marketed device The NOWDx COVID-19 Test is an in vitro lateral flow immunoassay intended for qualitative detection of total antibodies to SARS-CoV-2 in human whole blood venous and fingerstick
Detailed Description:
This study is designed to compare the performance of the NOWDx COVID-19 Test to an emergency use authorized PCR test result The intent is to show the rapid test device is comparable to a currently marketed device The NOWDx COVID-19 Test is an in vitro lateral flow immunoassay intended for qualitative detection of total antibodies to SARS-CoV-2 in human whole blood venous and fingerstick
The NOWDx COVID-19 Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2 indicating recent or prior infection At this time it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity Testing of human venous whole blood EDTA and fingerstick specimens are intended to be conducted in patient care settings authorized to perform CLIA waived tests
The NOWDx COVID-19 Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2 indicating recent or prior infection At this time it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity Testing of human venous whole blood EDTA and fingerstick specimens are intended to be conducted in patient care settings authorized to perform CLIA waived tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None