Clinical Evaluation of the BinaxNOW COVID-19 Antigen Card

About this Study

The primary objective of this study is to estimate the clinical sensitivity and specificity of the Lateral Flow COVID-19 test against reference in symptomatic and asymptomatic patients using nasal swabs.

Sponsor Protocol ID:2012101
IRB Number:TEMP-2020-2720
Closed for Enrollment
Observational
Observational/Not Applicable
May 11, 2020
Eligibility Criteria
Both Male and Female
No
No
Yes

Inclusion CriteriaSymptomatic Subject Inclusion Criteria: 
• Has presented to participating clinical study site, or is a hospital inpatient with at least two (2) symptoms of the following: new loss of taste or smell, fever, shortness of breath, diarrhea, headache, extreme tiredness, dry cough, sore throat, runny or stuffy nose, muscle aches. 
• Subject is suspected by study staff to have COVID-19. 

Asymptomatic Subject Inclusion Criteria: 
• Has presented to clinical study site, or is a hospital inpatient without symptoms of COVID-19 such as: new loss of taste or smell, fever, shortness of breath, diarrhea, headache, extreme tiredness, dry cough, sore throat, runny or stuffy nose, muscle aches.

Exclusion CriteriaExclusion Criteria for both Symptomatic and Asymptomatic Subjects: 
• Subjects with active nose bleeds or acute facial injuries/trauma. 
• Subject is currently enrolled in study to evaluate an investigational drug. 
• Subject has already participated in this study. 
• Subject unable or unwilling to provide informed consent. 
• Vulnerable populations as deemed inappropriate for study by site Principal Investigator.

Categories Click category to view its trials.
COVID-19 (Coronavirus)
Participating Locations
Emergency Room - Adult
University Hospital
Contact Information
Contact Name: Rebekah Peacock
Phone Number: 601-496-9600
Email: rpeacock@umc.edu
Principal Investigator:Jones, Alan E, M.D.
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