We have created a new type of COVID-19 test by fundamentally rethinking the mechanisms that underpin detection. We have taken cues from pharmaceutical and drug discovery fields, combining next-generation sensing technology with a user first approach.
Our mission was to design a test that people won’t mind using multiple times a week, whilst being sufficiently sensitive to mean that a single test is also extremely accurate.
When you are infected by a virus it leaves behind signs. These can include: a dead virus, viral shedding (like viral dead skin), antibodies (which your body produces in response to the virus) or a live virus itself. All of these viral artefacts can trigger a false positive result (ie. telling you you are infectious when you are not.)
This wasn’t much of a problem when we were focused on testing people with suspected symptoms. However, as we move to proactive screening - testing large groups of people multiple times a week - then the cost of these false positives starts to become a serious drain on people’s time, businesses’ resources and the economy.
Because of how they detect viral material, other antigen test technologies have to rely on more invasive methods of sample collection: nasal swabs, throat swabs, tonsil swabs and nasopharyngeal swabs. This makes them poorly suited to be used multiple times a week, and inaccessible to the elderly, the young and the disabled.
Our patented test uses the COVID-19 virus's binding mechanism as a trigger. Viruses bind to human cells in order to cause an infection; KnowNowᵀᴹ technology mimics a human cell and detects if a virus binds to it. As only a live virus can bind to it, a positive result means that a live virus is present now.
Our unique detection method has enabled the development of an antigen test that is accurate using only saliva mouth swabs. This has allowed us to design a test experience that is painless, easy, and works in 15 minutes to tell you if you are infectious at the time of the test.
Unless we are testing to see if people are currently infectious to others, then we risk isolating people who are not dangerous. These false positives will cause people to miss out on work, culture and travel unnecessarily. But don’t just take our word for it. →
“Testing to help slow the spread of SARS-CoV-2 asks not whether someone has RNA in their nose from earlier infection, but whether they are infectious today. It is a net loss to the health, social, and economic wellbeing of communities if post-infectious individuals test positive and isolate for 10 days.”
Know if you are currently infectious with COVID-19 in under 15 minutes with no other equipment.
Our unique approach makes our test both accurate and sensitive, both in the lab or in the real-world, with 100% specificity and 95.6% sensitivity.
Designed for scale our tests are easy to administer accurately and painless to receive.
Our tests only detect people with an active, infectious COVID-19 infection.
Can be used anywhere with no other equipment. The most accessible platform to house our assay technology.
Two prospective clinical evaluations were undertaken in the UK to determine clinical performance of the KnowNow™ SARS-CoV-2 Rapid Antigen Test. A total of 441 specimens were collected and analysed against reference standard test methods, where time from onset of symptoms was no more than 7 days and the Ct value of PCR was less 28.
Diagnostic sensitivity is a measure of how well the test correctly detects the presence of the condition or analyte. It is usually given as a percentage and is calculated by dividing the number of positive test results by the total number of analyte true positive samples. The higher the sensitivity the better the test is at correctly identifying persons with a condition. The KnowNow™ SARS-CoV-2 Rapid Antigen Test has an overall diagnostic sensitivity of 95.6% (95% CI 91.1-98.2%).
Diagnostic specificity is a measure of how well the test correctly detects the absence of the condition or analyte. It is usually given as a percentage and is calculated by dividing the number of negative test results by the total number of known negative samples. The higher the sensitivity the better the test is at correctly identifying persons who do not have the condition. The KnowNow™ SARS-CoV-2 Rapid Antigen Test has an overall diagnostic specificity of 100% (95% CI 98.6-100%).
Limit of Detection (LoD): A study was undertaken to determine the minimum titre of live virus that the device could consistently detect. The study used cultured virus of known titre (given as plaque forming units (Pfu)/ml). Inactivated virus was spiked into pooled confirmed negative saliva. The limit of detection was found to be 5 x 10² PFU/ml.
Risk analysis identified a number of potentially cross reacting viruses. The novel nature of the principle of operation of the assay means that potential cross reactivity is very limited. The following microorganisms were tested in triplicate as part of a study undertaken at the Liverpool School of Tropical Medicine:
Reproducibility and repeatability studies were undertaken. The results showed 100% reproducibility (105/105) and 99.1% repeatability (104/105).
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