Status:
UNKNOWN
Clinical Performance Evaluation of KnowNow SARS-CoV-2 Test for the Detection of COVID-19 Antigen
Lead Sponsor:
Vatic Ltd.
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Brief Summary
This is an international, multicentre, non-interventional, observational study to assess the clinical diagnostic performance of a rapid, point of care (POC) COVID-19 (SARS-CoV-2) antigen In vitro diag...
Detailed Description
The KnowNow SARS-CoV-2 Rapid Antigen Test which uses saliva and is a lateral flow diagnostic device that can detect the SARS-CoV-2 specific Antigens that are present on the surface of the virus. The K...
Eligibility Criteria
Inclusion
- Male or female aged 18 years or over (or age of adult consent in some states within the United States).
- Suspected COVID-19 infection and / or presenting with at least 1 recognised symptom Fever or chills. ie: Cough. Shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat
- Be willing and able to comply with study procedures.
- Be able to give written informed consent.
Exclusion
- Inability to give written informed consent.
- Vaccinated against SARS-CoV-2
- Adults unable to undertake the requirements of the nasopharyngeal or saliva sample collection for physical or psychological reasons
- Subjects with other significant disease, condition, or at the Clinician's discretion.
Key Trial Info
Start Date :
February 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2021
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04733170
Start Date
February 15 2021
End Date
August 31 2021
Last Update
February 25 2021
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