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How accurate are your tests?

COVID-19 test accuracy is typically determined by ‘specificity’ and ‘sensitivity’.

Specificity is about the extent to which you can eliminate false positives; sensitivity is how much virus needs to be present before a test picks it up. So there is always a need to strike a balance, when testing, between trying to pick up the virus as early as possible, versus accidentally delivering a positive test result for someone who is not actually infected.

The specificity of the KnowNowᵀᴹ Test is 100%. In more than 700 negative patient saliva samples, we haven’t had a single false positive.

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 very 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 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.

How specific is the KnowNowᵀᴹ 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.

Where do you make your KnowNowᵀᴹ tests?

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

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

Is there a limit to how frequently I can take your tests?

No, there's no limit at all. KnowNow is specifically designed for frequent testing in order to offer the best chance of identifying infectious individuals as early as possible.

We recommend that individuals are tested as regularly as possible to keep workplaces and communities safe. Depending on the scenario, we would recommend that testing is performed every 2-3 days, or even daily, depending on the scenario.

How long will it take a qualified clinician to administer each test?

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.

What's the long term vision for Vatic beyond COVID-19?

We’re focused on developing our predictive health technology and tests so that we can make medicine more proactive and help to predict illness before it becomes acute or infectious. We want to empower people to feel in charge of their own health and wellbeing by making testing more readily accessible and available, allowing for earlier prediction and prevention of acute illnesses.

Who makes the KnowNow Test?

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

Does the KnowNow Test identify all COVID-19 mutations?

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.

How should KnowNowᵀᴹ tests be stored?

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.

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