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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 2 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

Innate Infection Cohort> - PCR positives: persons who were symptomatic for COVID-19 and have tested positive for COVID-19 with an EUA or FDA cleared PCR test; 7+ days post positive PCR test - PCR negatives: persons who have never had COVID-19 and who have tested negative for COVID-19 with an EUA or FDA cleared PCR test; within 0-6 days post negative PCR test - persons 2+ years old Vaccination Cohort> - persons 7- 60 days post second dose of EUA COVID-19 vaccine - persons 18+ years old

Exclusion Criteria

Innate Infection Cohort> - PCR positives: persons with a COVID-19 positive test result >45 days old - PCR negatives: persons with any prior COVID-19 positive result - persons who have received COVID-19 vaccine - persons <2 years old Vaccination Cohort> - persons symptomatic or previously infected with COVID-19 prior to vaccination - persons <18 years old

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Persons tested with investigational device following PCR test 		Persons tested with investigational device who previously tested positive or negative for COVID-19 with an emergency use authorized or FDA cleared COVID-19 test
  • Device: NOWDx COVID-19 Test
    The investigational device is the NOWDx COVID-19 Test.
Experimental
Persons tested with investigational device following vaccination 		Persons tested with investigational device who previously were vaccinated for COVID-19 with an emergency use authorized or FDA cleared COVID-19 vaccine
  • Device: NOWDx COVID-19 Test
    The investigational device is the NOWDx COVID-19 Test.

Recruiting Locations

More Details

NCT ID
NCT04799392
Status
Terminated
Sponsor
NOWDiagnostics, Inc.

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.