At the moment, KnowNowᵀᴹ Tests are for professional use only, meaning that they need to be administered by a trained healthcare professional. This means that we can take orders from organisations that have in-house or outsourced healthcare professionals who can perform the tests, or testing service providers.
However, since the KnowNowᵀᴹ Test needs just a saliva sample, it is much easier to administer effectively than other similar tests, and still return highly sensitive results. So we are investigating whether specially-trained, competent individuals could be approved to administer KnowNow tests as well.
We are also in the process of trialling and seeking approval for a variation of the KnowNow test which could be administered by individuals themselves.
The adjective "vatic" means "describing or predicting what will happen in the future," and derives directly from the Latin word vates, meaning "seer" or "prophet."
We chose this name as it speaks to our mission to make healthcare more proactive and empowering, through predictive screening for acute disease.
No, not at all. It was really important to us when inventing this test, that it would be comfortable and easy enough that anyone would be happy to take a test every day if they needed to.
All the KnowNow test needs is a simple saliva sample from the mouth. Unlike alternative antigen tests or most PCR tests, the KnowNow test does not require the clinical professional to insert a swab very high inside the nose to collect a sample from the nasopharynx, nor does it require a tonsil swab. This is one COVID-19 test that won't make people gag or cry.
COVID-19 test accuracy is typically determined by ‘specificity’ and ‘sensitivity’.
Specificity is about the extent to which you can eliminate false positives; sensitivity is how much virus needs to be present before a test picks it up. So there is always a need to strike a balance, when testing, between trying to pick up the virus as early as possible, versus accidentally delivering a positive test result for someone who is not actually infected.
The specificity of the KnowNowᵀᴹ Test is 100%. In more than 700 negative patient saliva samples, we haven’t had a single false positive.
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 very 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 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 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.
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.
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.
To date we have conducted three clinical studies. The first was a UK Government-supported National Institute for Health Research (NIHR) study across ten UK hospitals; the second was with Liverpool School of Tropical Medicine, and the third is a community study that we have led ourselves. We have also carried out our own analytical assessments, as well as two Public Health England analytical assessments.
We have worked with over 280 negative patient samples and around 100 COVID-19 positive patients across our studies. We are also currently carrying out a 650+ patient clinical trial with sites in the UK, USA and Brazil to provide us with a higher volume of clinical data, and with a view to additional regulatory approvals to widen the reach of the impact we can have globally in pandemic recovery.
One box contains 25 tests, and measures 20cm (L) x 21cm (W) x 8cm (H).
The space required depends on how many tests you require at any given time. However, as the KnowNowᵀᴹ Tests can be stored at any temperature between 2 and 30 degrees, special storage facilities should not be required in the UK, unless there is unusually hot weather.
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.
The KnowNowᵀᴹ Test has been invented, developed and manufactured in the UK by Senseutics Limited, trading as Vatic.