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.
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.
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 300 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.
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.
KnowNowᵀᴹ Tests have been invented, developed and manufactured in the UK.
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.
There have been questions raised around the sensitivity of rapid lateral flow antigen testing for SARS-CoV-2 as compared to PCR testing. However, these questions have been strongly challenged by the scientific community.
PCR tests identify the presence of the SARS-CoV-2 virus in the body, regardless of whether the virus is actively infectious. The PCR testing process amplifies the genetic code of the virus so that even minuscule amounts of the virus in the sample can be picked up. This makes for a powerful test, but since viral fragments can linger in the body for weeks even after the infection has cleared, infected individuals being tested using PCR will show as positive for a median period of 22–33 days in total. On the other hand, most people infected with SARS-CoV-2 are contagious only for 4–8 days.
So whilst PCR testing for SARS-CoV-2 may have been considered the "gold standard" test up until now, it will by definition show different results when compared to lateral flow tests which aim to identify individuals based on viral loads which suggest they are within their infectious window. This discrepancy between what each test is actually testing for has caused some issues where PCR testing has been used to evaluate the effectiveness of lateral flow tests, such as in the mass testing rolled out in Liverpool in November 2020.
The KnowNowᵀᴹ Test goes a step beyond other lateral flow tests with its unique, patented detection mechanism which only shows a positive result when live infectious virus is identified in the sample. As a result, PCR tests will similarly show different results to the KnowNowᵀᴹ Test in certain cases, since they will show positive results even for individuals outside of their infectious period.
For a much more comprehensive and referenced answer, you may like to read "Clarifying the evidence on SARS-CoV-2 antigen rapid tests in public health responses to COVID-19" from the Lancet.
Yes, it will be very clear if the test has been carried out incorrectly and failed.
If there are no lines at all visible in the KnowNowᵀᴹ device test results window, then the test has failed, and it should be repeated with a new device and a fresh saliva sample.
SARS-CoV-2 is able to spread from individuals who are pre-symptomatic or asymptomatic. As a result, testing and isolation based on symptoms alone will not be sufficient to stop the spread.
This narrative review of 16 clinical studies around the globe concludes that between 40-45% of those infected with SARS-CoV-2 never develop symptoms, and that these asymptomatic carriers can infect others for an extended period, perhaps longer than 14 days.
Regular community testing with a rapid antigen test like the KnowNowᵀᴹ Test to identify asymptomatic, but infectious, individuals offers one way to break the chain of transmission and enable the re-opening of societies.
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 and COVID-19 antibody tests test for completely different things.
Antibody tests identify whether someone has had coronavirus in the past, whereas the KnowNowᵀᴹ Test detects whether an individual is currently infectious.
Antibody testing involves detecting the immune response in the human body to having fought off a virus. These tests look for an antibody created in the bloodstream in response to the presence of a virus in that environment. This is useful when testing the effectiveness of a vaccine, or understanding how far and wide a virus has spread. However, it is of limited usefulness to individuals, as it is only able to identify whether an individual has fought off the SARS-CoV-2 virus in the past. It cannot effectively confirm whether they are currently infected, or infectious.