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How sensitive is the KnowNowᵀᴹ Test?

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 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 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 Limit of Detection values for tests using universal standard metrics should be readily available in the public domain to enable like-for-like comparison.

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 does KnowNowᵀᴹ compare to COVID-19 antibody 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.

Who makes the KnowNow Test?

The KnowNowᵀᴹ Test has been invented, developed and manufactured in the UK by Senseutics Limited, trading as Vatic.

How do I order tests?

We're so pleased that you'd like to order our KnowNowᵀᴹ Tests. At the moment we are running some pilots with a few key partners, before distributing our tests more widely.

Please fill in our form and our team will get back to you.

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.

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

How soon after exposure would the KnowNowᵀᴹ Test give a positive result?

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.

Who is Vatic?

Vatic is a predictive health company focused on making medicine more proactive. We deliver on-the-spot tests which detect subtle biomarkers in people’s bodies to predict illness before it becomes acute or infectious.

Our first product is KnowNowᵀᴹ, a rapid turnaround COVID-19 antigen test, that is designed to identify COVID-positive people before they become highly infectious*, based on just a small saliva sample.

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