KnowNowᵀᴹ Tests have been invented, developed and manufactured in the UK.
Vatic is a predictive health company focused on making medicine more proactive. We deliver on-the-spot tests which detect subtle biomarkers in people’s bodies to predict illness before it becomes acute or infectious.
Our first product is KnowNowᵀᴹ, a rapid turnaround COVID-19 antigen test, that is designed to identify COVID-positive people before they become highly infectious*, based on just a small saliva sample.
KnowNowᵀᴹ offers two key benefits over polymerase chain reaction (PCR) tests.
The first benefit is that the KnowNowᵀᴹ test needs only a saliva sample, which can be taken easily and comfortably from the mouth. PCR tests usually need a nasopharyngeal, anterior nasal or tonsil sample, all of which are painful and unpleasant for the individual being tested and more challenging to collect effectively for the clinical professional administering the test. No one wants to be made to cry or gag, or make someone else cry or gag, on a regular basis!
The second benefit is that the KnowNow test uses its unique detection mechanism to determine whether an individual is actually infectious, whereas PCR tests identify whether SARS-CoV-2 viral matter is present in an individual's body, regardless of whether it is already inactive.
Although PCR tests have been seen as the "gold standard" test for the SARS-CoV-2 virus, they do have a number of drawbacks. Laboratory processing is required, meaning that there is a delay before results can be returned, and the associated costs are relatively high. Also the detection mechanism does not specifically identify whether individuals are infectious. In fact, PCR tests detect the virus long after the infectious period, and individuals can continue to test positive for a mean of 17 days after they have stopped being able to infect others (source). This means that people who are not infectious are unnecessarily quarantined as a result of a positive PCR test.
If there is one red line visible next to the "C" in the KnowNowᵀᴹ device test results window, and any line at all, no matter how faint, appears next to the "T", then the test result is positive. This indicates that the SARS-CoV-2 antigen has been detected in the sample.
Following a positive result, current government guidance on matters including self-isolation and reporting the result should be followed.
If there is one red line visible next to the "C" in the KnowNow device test results window, and no line at all next to the "T", then the test result is negative. This indicates that no SARS-CoV-2 antigen has been detected in the sample.
The KnowNowᵀᴹ test has been developed to Vatic's stringent standards of quality and safety.
It has undergone the necessary clinical trials and performance tests and has been shown to meet the specific requirements published by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA).
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.
From our own studies with partners, we estimate that a clinical professional can administer one test every 3.5 to 4 minutes. This assumes that they collect saliva samples from individuals, set the KnowNowᵀᴹ Test devices aside to develop for 15 minutes, and collect samples from further individuals before reading the results from earlier tests.
One box contains 25 tests, and measures 20cm (L) x 21cm (W) x 8cm (H).
What’s important when it comes to sensitivity is how much virus needs to be present in the patient sample for the test to give a positive signal. This is known as the 'Limit of Detection', and we measure this rather than clinical sensitivity as it is much more informative.
Our Limit of Detection is between 50,000 and 200,000 viral copies per mL, making our test more sensitive than other rapid antigen tests available. The Abbott BinaxNow test, for example, needs 1,000,000 viral copies per mL in order to get a positive signal.
The KnowNowᵀᴹ Test's low Limit of Detection means it can detect infected people as early as day 3 to 4 of infection. This is before they become highly infectious, and a day or two earlier than most tests available (based on models of viral load in disease progression).
If you'd like to read more about this subject, we recommend reading this paper. It argues that the "Limit of Detection matters and directly impacts efforts to identify, control, and contain outbreaks during this pandemic" since "higher LoD are likely to miss nonnegligible fractions of infected individuals." It also makes the case that Limit of Detection values for tests using universal standard metrics should be readily available in the public domain to enable like-for-like comparison.
The expiry date of KnowNowᵀᴹ Tests will be clearly marked on their packaging, and you can expect the shelf-life of each box of tests to be at least four months.
No, we're not taking any shortcuts or risks. The KnowNowᵀᴹ test has been precisely developed, rigorously tested, and approved by the necessary bodies.
As with COVID vaccine development, the speed at which we’ve been able to move has been accelerated by the enhanced support and focus afforded to the sector by all stakeholders, such as the government, the pharmaceuticals industry, academic institutions and so on.
We have conducted two clinical studies. The first was a UK Government-based study across ten UK hospitals; the second was with Liverpool School of Tropical Medicine. We have also carried out our own analytical assessments, as well as two Public Health England analytical assessments.
The KnowNowᵀᴹ Test has been CE marked for professional use within a healthcare context and is approved by the UK's Medicines and Healthcare products Regulatory Agency (MHRA).