Clinical Performance Evaluation of KnowNow SARS-CoV-2 Test for the Detection of COVID-19 Antigen
NCT04733170 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 600
Last updated 2021-02-25
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 diagnostic (IVD), The KnowNow SARS-CoV-2 Rapid Antigen Test, using saliva samples when compared to reverse transcription polymerase chain reaction (RT-PCR) as the standard detection of COVID-19 infection.
Conditions
- Covid19
Interventions
- DIAGNOSTIC_TEST
-
KnowNow SARS-CoV-2 Rapid Antigen Test
KnowNow SARS-CoV-2 Rapid Antigen Test for the detection of Covid-19 in saliva, as compared to high sensitivity reverse transcription polymerase chain reaction (RT-PCR) of nasopharyngeal swabs as the reference test method
Sponsors & Collaborators
-
Vatic Ltd.
lead INDUSTRY
Principal Investigators
-
Alex Sheppard, BA · Vatic Ltd.
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-15
- Primary Completion
- 2021-08-31
- Completion
- 2021-08-31
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