Status:
COMPLETED
Sample Collection for Evaluation of the Panbio™ COVID-19/ Flu A&B Rapid Panel.
Lead Sponsor:
Abbott Rapid Dx
Conditions:
COVID-19
Influenza A
Eligibility:
All Genders
14-100 years
Phase:
NA
Brief Summary
This study is designed as a prospective, multicentric, sample collection study. The collected samples will be used for diagnostic research, product development and validation of the Panbio™ COVID-19/ ...
Detailed Description
A minimum of 665 male and female Subjects will be prospectively enrolled at multiple clinical sites. A minimum of 90 Flu A reference positive subjects, a minimum of 90 Flu B reference positive subject...
Eligibility Criteria
Inclusion
- Subjects \>14 years of age who are able and willing to provide written informed consent, and deemed suitable for nasopharyngeal sampling in accordance with local procedures, suspected of having a respiratory viral infection consistent with COVID-19 and/or Flu by their healthcare provider within the first five days of the onset of symptoms, and presenting at least two of the following symptoms: fever, headache, extreme tiredness, dry cough, sore throat, runny or stuffy nose, muscle aches, loss of smell, loss of taste or shortness of breath, will be prospectively enrolled.
Exclusion
- • Subject has had a nasal or a nasopharyngeal swab taken within the last 4 hours.
- Subject has active nose bleeds or acute facial injuries/trauma
- Subject has received a nasal vaccine (i.e., FluMist®) within the previous five (5) days.
- Subject is currently taking or has taken an antiviral medication-i.e., Amantadine, Rimantadine, Relenza® (Zanamivir), Tamiflu® (Oseltamivir Phosphate), and Flumadine®-for influenza within the previous thirty (30) days.
- Subject is currently enrolled in a study to evaluate an investigational drug.
- Subject is unwilling or unable to provide informed consent.
- Vulnerable populations as deemed inappropriate for study by the site's PI and/or reviewing REC.
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2022
Estimated Enrollment :
676 Patients enrolled
Trial Details
Trial ID
NCT05354115
Start Date
March 14 2022
End Date
August 22 2022
Last Update
November 9 2023
Active Locations (1)
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1
Urgent Care Clinical Trials Easley
Easley, South Carolina, United States, 29640