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How have you validated the accuracy of your tests?

To date we have conducted multiple clinical and analytical studies during the development of our testing technology. The first of these was a United Kingdom Government-supported National Institute for Health Research (NIHR) study conducted across ten UK hospitals focusing on saliva feasibility, usability and sampling methodology. 

The second clinical study was conducted in partnership with the Liverpool School of Tropical Medicine.

Third, Vatic Health  carried out our own analytical assessments, as well as conducted two Public Health England analytical assessments. Vatic Health has worked with over 280 negative patient samples and nearly 100 COVID-19 positive patients across these studies. We are also conducting 600 patient clinical trials with sites across the United States, the United Kingdom and Brazil to provide a higher volume of clinical data so that we may widen the reach of the impact the Vatic COVID-19 test can have globally in pandemic recovery.


How does KnowNowᵀᴹ compare to COVID-19 PCR tests?

The KnowNowᵀᴹ test offers two key benefits over polymerase chain reaction (PCR) tests:     

 

The KnowNowᵀᴹ test needs only a small mouth or shallow nose sample. Many PCR tests require a nasopharyngeal, or tonsil sample, which may be painful and unpleasant for the individual being tested and more challenging to collect effectively for the medical professional administering the test. 

 

Secondly, the KnowNowᵀᴹ test uses its unique detection mechanism to determine the presence of live virus, whereas PCR tests only identify whether COVID-19 viral genetic material is present in an individual's body, regardless of whether it is already inactive.     

     

Although PCR tests have traditionally been seen as the "gold standard" for detecting the COVID-19 virus, they do have a number of potential drawbacks:     

     

  1. Laboratory processing is required for a PCR test, which may lead to a delay of multiple days before results can be returned
  2. Even with costs coming down as the pandemic progresses, compared with rapid tests it’s relatively expensive.
  3. The detection mechanism in a PCR test does not specifically identify whether individuals are currently infectious. In fact, PCR tests detect the virus long after the infectious period and thus, individuals can continue to test positive for a mean of 17 days after they are no longer infectious (see here). This means that people who are not infectious may be unnecessarily quarantined.

How accurate are your tests?

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

Specificity is how good the test is at identifying people that do not have COVID.  In clinical trials in the United Kingdom, the specificity of the KnowNowᵀᴹ test was 100% and in more than 700 negative saliva samples collected, the KnowNowᵀᴹ test returned ZERO positives. If someone is given a positive result for COVID using a rapid test - and they don’t actually have COVID -  it’s known as a false positive.   

Sensitivity measures how often the test correctly identifies those who have the virus. That of the KnowNowᵀᴹ test is high - in the UK clinical studies it came out as 95.6% within symptomatic people.

Is KnowNowᵀᴹ approved and safe?

The KnowNowᵀᴹ test has been developed to Vatic's stringent standards of quality and safety.

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.

How does KnowNowᵀᴹ compare to other COVID-19 lateral flow antigen tests?

The KnowNowᵀᴹ test is different when compared to many other lateral flow antigen tests in three key areas:    

  1. The KnowNowᵀᴹ test needs only a mouth saliva or nose sample. Other lateral flow antigen tests can require deep nose or throat nasal samples (nasopharyngeal), which may be painful and unpleasant for the individual being tested (especially the young and those with a disability) and so are more challenging to collect effectively for the clinical professional administering the test. 
  2. The KnowNowᵀᴹ test looks specifically for the spike protein of the live virus, which is the key that unlocks your cells, allowing the coronavirus to infect you with COVID-19. We know of no other tests that use this approach. This approach should make the KnowNowᵀᴹ test robust against mutations - we are currently gathering more evidence of this with a study alongside Gifford Bioscience. 
  3. The Limit of Detection (LoD) is the smallest amount of virus in a sample that a given device can consistently detect. Testing in the United Kingdom has shown that the KnowNow test has a comparable limit of detection to approved and widely used devices, and is able to detect the presence of the virus even when there is a low number of active virus particles present. Our Limit of Detection is around  500 pfu/mL (pfu/mL is a measure of plaque-forming units which describes the number of virus particles that are capable of replicating in a sample).

How does KnowNowᵀᴹ compare to COVID-19 antibody tests?

The KnowNowᵀᴹ test and regular COVID-19 antibody tests look for completely different viral information. The Vatic KnowNowᵀᴹ test detects whether live virus is present, whereas antibody tests identify whether someone has had coronavirus in the past and thus exhibits antibodies to coronavirus.

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