To date we have conducted multiple clinical and analytical studies during the development of our testing technology. The first of these was a United Kingdom Government-supported National Institute for Health Research (NIHR) study conducted across ten UK hospitals focusing on saliva feasibility, usability and sampling methodology.
The second clinical study was conducted in partnership with the Liverpool School of Tropical Medicine.
Third, Vatic Health carried out our own analytical assessments, as well as conducted two Public Health England analytical assessments. Vatic Health has worked with over 280 negative patient samples and nearly 100 COVID-19 positive patients across these studies. We are also conducting 600 patient clinical trials with sites across the United States, the United Kingdom and Brazil to provide a higher volume of clinical data so that we may widen the reach of the impact the Vatic COVID-19 test can have globally in pandemic recovery.
The KnowNowᵀᴹ test and regular COVID-19 antibody tests look for completely different viral information. The Vatic KnowNowᵀᴹ test detects whether live virus is present, whereas antibody tests identify whether someone has had coronavirus in the past and thus exhibits antibodies to coronavirus.
The KnowNowᵀᴹ test offers two key benefits over polymerase chain reaction (PCR) tests:
The KnowNowᵀᴹ test needs only a small mouth or shallow nose sample. Many PCR tests require a nasopharyngeal, or tonsil sample, which may be painful and unpleasant for the individual being tested and more challenging to collect effectively for the medical professional administering the test.
Secondly, the KnowNowᵀᴹ test uses its unique detection mechanism to determine the presence of live virus, whereas PCR tests only identify whether COVID-19 viral genetic material is present in an individual's body, regardless of whether it is already inactive.
Although PCR tests have traditionally been seen as the "gold standard" for detecting the COVID-19 virus, they do have a number of potential drawbacks:
COVID-19 test accuracy is typically determined by two characteristics: ‘specificity’ and ‘sensitivity’.
Specificity is how good the test is at identifying people that do not have COVID. In clinical trials in the United Kingdom, the specificity of the KnowNowᵀᴹ test was 100% and in more than 700 negative saliva samples collected, the KnowNowᵀᴹ test returned ZERO positives. If someone is given a positive result for COVID using a rapid test - and they don’t actually have COVID - it’s known as a false positive.
Sensitivity measures how often the test correctly identifies those who have the virus. That of the KnowNowᵀᴹ test is high - in the UK clinical studies it came out as 95.6% within symptomatic people.
The KnowNowᵀᴹ test has been developed to Vatic's stringent standards of quality and safety.
The KnowNow test has been CE marked for professional use in a healthcare setting and has been registered for use in the UK and the EU.
The KnowNowᵀᴹ test is different when compared to many other lateral flow antigen tests in three key areas: