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.
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 KnowNow test is an affordable, user friendly, and point of care device that
can be mass produced as part of a multipronged strategy to address the global COVID-19
pandemic.
A saliva sample is collected from someone with suspected COVID-19 and mixed with a running
buffer. The mixture is added to the sample pad of the KnowNow test, from where it migrates
through the lateral flow strip. If COVID-19 Antigens are present, they bind to capture
proteins on a test line and are made visible by secondary reagents within the device. The
test result is visually assessed after 15-30 minutes and provides a binary positive (two
lines) or negative (one line) result. Levels of COVID-19 Antigen differ dependent on disease
progression. A visible test line (marked T) indicates the presence of COVID-19 Antigen in
sufficient quantity in the collected sample to be detected. The appearance of the control
line (marked C) confirms that the test has been performed correctly.
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
Inclusion Criteria:
1. Male or female aged 18 years or over (or age of adult consent in some states within
the United States).
2. 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
3. Be willing and able to comply with study procedures.
4. Be able to give written informed consent.
Exclusion Criteria:
1. Inability to give written informed consent.
2. Vaccinated against SARS-CoV-2
3. Adults unable to undertake the requirements of the nasopharyngeal or saliva sample
collection for physical or psychological reasons
4. Subjects with other significant disease, condition, or at the Clinician's discretion.
Andrea Goodyer, BSc (Hons)
07930277125
andrea.goodyer@clinicallyconnected.com
Laurie Comeau, BSc (Hons)
Laurie Comeau
Alex Sheppard, BA, Study Director
Vatic Ltd.