NCT04690413

NOWDx Test for the Detection of Antibodies to COVID-19

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: NOWDiagnostics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19
• SARS-CoV-2
• Coronavirus

Interventions

Type	Name	Description
DEVICE	NOWDx COVID-19 Test	The investigational device is the NOWDx COVID-19 Test.

Timeline

• Start date: 2020-09-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2020-12-30
• Last updated: 2024-03-01
• Results posted: 2022-10-28

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study