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.
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.
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).
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 KnowNowᵀᴹ Test's specificity is 100%. In more than 700 negative patient saliva samples, it hasn’t returned a single false positive result.
This is so important for getting life back to normal. We don't want anyone to be stopped from going to work, heading off on holiday or socialising at events, when actually it would be perfectly safe for them to do these things.
Specificity is particularly important when disease prevalence is low and tests are intended to be used at enormous scale. For example, if a test with just a 3% false positive rate is used on one million people per day, that would result in 30,000 people per day being falsely identified as infectious with COVID-19 and being unnecessarily asked to self-isolate.
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.
It should not be necessary to perform more than one test on a given individual at a single point in time, unless the KnowNowᵀᴹ device test results window displays no lines at all, meaning that the test has failed, or unless it was not possible to read the test results within 15 to 60 minutes of applying the mixed saliva and buffer solution to the KnowNowᵀᴹ device.
However, receiving a negative result does not mean that the individual tested can't be exposed to the SARS-CoV-2 virus following the test. So we do recommend that individuals are tested regularly to keep workplaces and communities safe. Depending on the scenario, we would recommend testing is repeated every 1 to 3 days.
So that the KnowNowᵀᴹ Test is used as effectively as possible, it currently needs to be administered by a trained healthcare professional.
A trained healthcare professional is defined by the Medicines and Healthcare products Regulatory Agency (MHRA) in the Target Product Profile for Point of Care SARS-CoV-2 Detection Tests as a professional belonging to one of the 10 health and social care professional bodies that are overseen by the Professional Standards Authority. You can find a list of these professions here.
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 other 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 KnowNowᵀᴹ Test which could be administered by individuals themselves.
The KnowNowᵀᴹ Test is the UK's only on-the-spot COVID-19 test that uses just your saliva to tell you if you are currently able to infect someone else with COVID-19.
Unlike other tests, the KnowNowᵀᴹ Test won't give you a positive result if you have been exposed to the SARS-CoV-2 virus in the past, but are no longer able to infect other people.
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.