VATIC-0101
Research type
Research Study
Full title
Clinical Performance Evaluation of KnowNow SARS-CoV2 Test for the Detection of COVID-19 Antigen
IRAS ID
281953
Contact name
Alex Sheppard
Contact email
Sponsor organisation
Senseutics Ltd, trading as Vatic
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 18 days
Research summary
SARS-CoV-2 was declared a pandemic on 11 March 2020 by the World Health Organization (WHO). Some people with the virus may have mild symptoms. Some older adults and those with underlying health conditions may develop more severe symptoms leading to hospitalization, increased support in an intensive care unit, or even death. There are currently few approved vaccines and treatments against the virus and large scale testing to contain its spread remains a high priority.
Given the spread and impact of the ongoing pandemic, there's a significant need for faster, user-friendly and mass producible ways to test people for COVID-19. Lateral flow antigen tests, similar in design to pregnancy tests kits (in this study called the KnowNow SARS-CoV-2 Rapid Antigen Test) are affordable, quicker and easier to use than RT-PCR and can be run without a separate laboratory or specialized equipment.
For the study, one mucus sample from the back of the nose and two saliva samples will be collected at 1 appointment only from suspected COVID-19 infected patients.
A Standard of care (SOC) sample will be collected via the standard COVID-19 testing procedure with result via Track and Trace system issued by text message.
It is envisaged the study will last 6 months at sites in the UK (2 GP practices), USA & Brazil.REC name
Wales REC 4
REC reference
21/WA/0113
Date of REC Opinion
9 Apr 2021
REC opinion
Favourable Opinion