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.
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.
The KnowNowᵀᴹ Test has been invented, developed and manufactured in the UK by Senseutics Limited, trading as Vatic.
The KnowNowᵀᴹ test's unique detection mechanism identifies the infectiousness of the people tested. As a result, from our modelling based on accepted and peer-reviewed scientific literature, the KnowNowᵀᴹ test will detect asymptomatic people who are infectious with COVID-19.
The KnowNowᵀᴹ test has an impressively low limit of detection for an on-the-spot equipment-less test, of between 50,000 and 200,000 viral copies per mL, and so it is sensitive enough to identify infectious asymptomatic carriers even if they have low viral loads.
As the KnowNowᵀᴹ Test makes testing quicker, easier and more accessible, more people can get tested on an ongoing basis. Regular testing improves the chances of picking up asymptomatic carriers. Since the KnowNowᵀᴹ Test can detect the virus on day 3 to 4 after infection, based on KnowNow's low limit of detection and accepted models of viral load in disease progression, it identifies these carriers before they’re at a high risk of infecting other people.
Testing to identify asymptomatic carriers is so important, since they make up a large proportion of people who are infectious and enable the virus to keep spreading. 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.
If you have already activated your sample pack please go to the activation link that we emailed to you. Alternatively, if you fill in your email again we will re-send the activation link to you.
Although vaccine rollout is progressing extremely quickly in the UK, the government expects that it will be the end of July 2021 before every adult in the UK has been offered their first dose of a COVID-19 vaccine. Second doses should be received around 12 weeks after the first, and so it is likely to be the end of October 2021 before every adult has received both doses.
In the meantime, whilst we await full vaccine rollout, regular rapid antigen testing offers a way to enable the re-opening of society.
Beyond this, it is also important to consider that no vaccine is 100% effective even after 2 doses, that not everyone will accept or be able to have the vaccine, and that there is uncertainty as to whether the vaccines will work effectively against current or future mutations of the virus. We should also consider the fact that the UK is very much ahead of other countries around the world in progressing its vaccine rollout, and that it will still be some time before the vast majority of people globally will be vaccinated.
With these factors in mind, regular testing is likely to play a role in keeping societies safe and open for some time to come.
We chose to design our unique KnowNowᵀᴹ test for COVID-19 infectiousness to work with a simple saliva sample, so that it would be comfortable and easy to administer, and to ensure that anyone would be happy to take a test every day if required. We believe that patient comfort and happiness leads to increased participation in routine testing, and ultimately increases the probability that COVID positive patients can be detected before they've had a chance to infect others.
The focus of our first clinical study was to assess the feasibility of using saliva sampling, to refine our saliva collection method, and also to assess the overall usability of the KnowNow test. This was a UK Government-supported National Institute for Health Research (NIHR) study carried out across ten UK hospitals with 100 patients participating. Through this study we determined that saliva sampling was both effective and user-friendly, and identified a specific swab for sampling. We chose not to opt for a spit collection method for our saliva sample, as providing a spit sample can be challenging for some patients, particularly the elderly or those suffering with COVID-19 symptoms.
For other COVID-19 tests, throat and nasopharyngeal swabbing is one of the most common types of sample collection. However, a number of studies have explored various issues with these types of sample collection, including:
Some tests have been designed to work with anterior nasal swabs, as a somewhat less invasive alternative to nasopharyngeal swabs. However, there is some evidence to suggest that nasal swab testing produces less sensitive results and may miss patients with lower viral loads (4).
The mechanism underpinning the KnowNowᵀᴹ test mimics the means through which the virus interacts with the surface of a human cell in order to detect it. As a result, we expect that it will continue to identify the SARS-CoV-2 virus even in the face of further potential mutation in the future, unlike tests based on antibodies.
We have modelled the difference between the Wuhan and 501Y mutations in a recombinant protein model to give us initial analytical evidence that the KnowNow test reacts to these variations of concern. And we are currently carrying out a study on live samples of these and other mutations to gather practical evidence of this.
In fact, we predict that the KnowNowᵀᴹ test may potentially become even more sensitive as the virus mutates to become more infectious. And we will continue to carry out further analyses and studies to support this prediction, and confirm that KnowNow continues to function on newer mutations as they arise.
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 KnowNowᵀᴹ test will show a positive result from day 3 or 4 after exposure to the SARS-CoV-2 virus. This is earlier than other rapid antigen tests, which usually start to show positive results around day 5 or later.
This also means that individuals will receive a positive KnowNowᵀᴹ test 1 or 2 days before they are at very high risk of infecting others. So where there is a regular testing programme in place, individuals can quickly be isolated before they become highly infectious and the spread of the virus can be prevented.
The basis for this is our analysis of models of viral load in disease progression, such as the one shown within "Test sensitivity is secondary to frequency and turnaround time for COVID-19 screening" by Dr Michael Mina et al, alongside the low limit of detection of the KnowNowᵀᴹ test of 50,000 to 200,000 viral copies per mL.
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.