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).
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.
Device: NOWDx COVID-19 Test
The investigational device is the NOWDx COVID-19 Test.
Inclusion Criteria:
- Persons ≥18 years old;
- Persons who have tested positive or negative (within 6 days) for COVID-19 with an
emergency use authorized molecular (PCR) test and can furnish said test report.
Exclusion Criteria:
- Persons <18 years old;
- Persons who have previously participated in a NOWDx study.
Del Sol Research Management, LLC
Tucson, Arizona, United States
Comprehensive Clinical Research, LLC
West Palm Beach, Florida, United States
Clinical Research Solutions, LLC
Jackson, Tennessee, United States
Beth L Cobb, Principal Investigator
NOWDiagnostics, Inc.