Trials / Terminated
TerminatedNCT04799392
NOWDx Test for the Detection of Antibodies to COVID-19 in Lay Persons
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- NOWDiagnostics, Inc. · Industry
- Sex
- All
- Age
- 2 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 fingerstick whole blood at the Point of Care (POC); i.e. in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation; and at home.
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 fingerstick whole blood at the Point of Care (POC); i.e. in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation; and at home. 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 fingerstick whole blood is intended to be conducted in a home-like setting of a facility authorized to perform CLIA waived tests.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NOWDx COVID-19 Test | The investigational device is the NOWDx COVID-19 Test. |
Timeline
- Start date
- 2021-04-01
- Primary completion
- 2021-10-28
- Completion
- 2021-10-28
- First posted
- 2021-03-16
- Last updated
- 2021-11-05
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04799392. Inclusion in this directory is not an endorsement.