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Where do you make your KnowNowᵀᴹ tests?

KnowNowᵀᴹ Tests have been invented, developed and manufactured in the UK.

When do you recommend tests are performed?

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.

How big is a KnowNowᵀᴹ Test kit?

One box contains 25 tests, and measures 20cm (L) x 21cm (W) x 8cm (H).

Are you taking shortcuts or risks by developing the KnowNowᵀᴹ Test so quickly?

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).

Why does the KnowNowᵀᴹ test use a saliva sample?

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:

  • The sample collection method requires a swab to be inserted into the patient's throat and/or far into their nostril and rotated, causing discomfort to patients due to the procedure’s invasiveness, and even inducing bleeding in their tonsils and posterior pharynx. (1)
  • The discomfort or even pain of the sample collection method has a detrimental impact on compliance for serial testing, as patients are unwilling to subject themselves to the test on a regular basis. (2)
  • Nasopharyngeal sample collection presents a considerable risk to healthcare workers, because it can induce patients to sneeze or cough, expelling virus particles. (2)
  • There are several situations where nasopharyngeal swabs would cause particular harm, such as in patients with coagulopathy, those undergoing anticoagulant therapy, or those with significant nasal septum deviation. (3)
  • These tests are not always successful at the first attempt, even though performed by trained healthcare workers, and shortages of swabs and protective equipment are frequently reported. (3)
  • They show relatively poor sensitivity for SARS-CoV-2 detection in early infection and are inconsistent during serial testing. (2)

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).

References:

(1) Exploring salivary diagnostics in COVID-19: a scoping review and research suggestions

(2) Saliva is more sensitive for SARS-CoV-2 detection in COVID-19 patients than nasopharyngeal swabs

(3) Saliva as a Candidate for COVID-19 Diagnostic Testing: A Meta-Analysis

(4) Nasal-Swab Testing Misses Patients with Low SARS-CoV-2 Viral Loads

What is a KnowNowᵀᴹ Test?

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.

Who can administer the KnowNowᵀᴹ Test?

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.

How frequently should employees or visitors be tested?

We recommend that individuals are tested as regularly as possible to keep workplaces, venues and communities safe.

It is important to remember that individuals can still go on to be exposed to the virus following a negative test result. Additionally, a high proportion of infectious people show no symptoms at all, and so regular testing is key to breaking the chain of transmission.

Depending on the scenario, we would recommend that testing is performed every 2-3 days, or daily, depending on the scenario.

Why do you need my company email to activate my sample pack?

So that we adhere to the strict rules around lateral flow tests, we have to make sure that anyone activating a sample pack is doing so purely to learn more about KnowNow Testing, and not as means of administering a clinical test.

How is a KnowNowᵀᴹ Test administered?

There are just 4 simple steps to the KnowNowᵀᴹ Test.

  1. Swab the mouth: The KnowNowᵀᴹ Test requires just a saliva sample to be taken easily and comfortably from the mouth. We know how uncomfortable and painful other lateral flow antigen tests or polymerase chain reaction (PCR) tests can be, with swabs going high into nostrils and all the way back to tonsils. It was really important to us that people would feel happy to take a KnowNow test on a regular basis.
  2. Shake the tube: The saliva swab is placed into a buffer solution in a small tube, and shaken up to mix it well.
  3. Squeeze on panel: A few drops of the mixed solution is squeezed onto the KnowNowᵀᴹ Test device.
  4. Know in 15 minutes: It takes just 15 minutes for the positive or negative result to appear in the test result window on the KnowNowᵀᴹ Test device. No need to wait 24-48 hours for results, as you would with a PCR test.

Can anyone order KnowNowᵀᴹ Tests?

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.

Had COVID - 19 symptoms in the last 2 days? Apply here to help us make testing accessible to all.