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.
We're so pleased that you'd like to order our KnowNowᵀᴹ Tests. At the moment we are running some pilots with a few key partners, before distributing our tests more widely.
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There are no health risks associated with using the KnowNow test itself, and it is safe to use on all individuals.
Receiving a negative result means that the individual tested does not have any live virus in the sample provided and is not currently infectious to others. However, it's important to be aware that they could still be exposed to the SARS-CoV-2 virus following the test. It could also be possible that the individual tested has already been exposed to the virus 1 or 2 days ago, and they have not yet become infectious to others.
As a result, we recommend that individuals are tested as regularly as possible to keep workplaces and communities safe. Depending on the scenario, we would recommend testing is repeated every 1 to 3 days.
If this regular testing is combined with mask wearing, hand washing and social distancing, the risk of virus transmission is vastly decreased.
KnowNowᵀᴹ Tests should be stored between 2 and 30 degrees celsius, which means it's fine to store it at room temperature in the UK's mild climate.
There's no need to store it inside a fridge, unless you're expecting extremely hot weather. If you do choose to refrigerate the test though, just make sure it comes to room temperature before using it.
The KnowNowᵀᴹ Test device should also be stored still sealed in its foil pouch. Once removed from the foil pouch, it should be used within one hour.
A lateral flow test is a simple diagnostic device designed to detect the presence or absence of a target substance in a liquid sample without the need for specialised and costly equipment.
The most commonly recognised type of lateral flow rapid test strip is the pregnancy test.
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.
We recommend that tests are performed at the earliest opportunity possible, to ensure that individuals in the workplace, venue or community don't come into contact with each other prior to testing.
There's no particular time of day that's best to perform a test. Although it is important that individuals haven't had anything to eat or drink, and haven't smoked, within the 30 minutes prior to taking the test.
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.
The KnowNowᵀᴹ test will provide a result within 17-18 minutes of an individual arriving for their test.
The process of taking the saliva sample, mixing it with the buffer solution and dropping it onto the KnowNow test device should take a clinical professional no more than 2 to 3 minutes.
It then takes just 15 minutes for the test result to develop in the KnowNow device test results window.
The test result should not be read and interpreted after 60 minutes. If it wasn't possible to read and interpret the results between 15 and 60 minutes after dropping the solution into the sample well, the test should be discarded and the process repeated with another new test and saliva sample.
The Limit of Detection (LoD) is the smallest amount of virus in a sample that a given device can consistently detect.
The Liverpool School of Tropical Medicine carried out an analytical study of the KnowNowᵀᴹ test, which determined that the LoD is 500 plaque-forming units per millilitre (PFU/ml). Based on accepted models of viral load in disease progression, this very low LoD suggests that the KnowNow test 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.
In the absence of a single study that compares the LoD of KnowNowᵀᴹ to that of other tests, it is not possible to do a like-for-like comparison of the LoDs of different lateral flow tests determined by different studies. This is because there wouldn't be parity across cell cultures and strains of the virus used in the different studies. Additionally, it's important to consider that what the KnowNowᵀᴹ test detects is fundamentally different from other tests. KnowNowᵀᴹ is a true infectivity test which looks exclusively for the spike protein only present on active SARS-CoV-2 viruses. Whereas other lateral flow tests detect the nucleocapsid protein encapsulated in the centre of the virus, which can be present whether the virus is active or not.
The PFU/ml measure, as used in the Liverpool School of Tropical Medicine KnowNowᵀᴹ analytical study, is a measure of only the number of virus particles capable of forming plaques in a given sample - viral particles that are defective or which fail to infect their target cell will not produce a plaque and so are not counted by this measure. No inference can be made about the relationship of PFU to the overall number of viral particles in the sample, since this will differ from sample to sample.
Since the KnowNow test specifically detects infectious viral particles only, an LoD measured in PFU/ml is an informative and appropriate measure. However, for other lateral flow tests which indiscriminately detect active and inactive viral particles, an LoD referencing PFU/ml is not particularly informative or comparable to the KnowNowᵀᴹ LoD. For example, the sample used to determine LoD may have had a very low PFU/ml, but many inactive viral particles which were detected by the test. Ultimately, other lateral flow tests are not true tests for COVID infectivity, they do not detect only infectious virus like the KnowNowᵀᴹ test does.
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 LoD values for tests should be benchmarked against a universal standard and readily available in the public domain to enable like-for-like comparison of SARS-CoV-2 detection methods.