UK company Intelligent Fingerprinting, manufacturers of the world’s first and only fingerprint sweat drug test, has now developed an easy-to-use saliva-based lateral flow test for the rapid detection of the COVID-19 antigen. In contrast to existing COVID-19 tests that require unpleasant, invasive nose and throat swabs, Intelligent Fingerprinting’s test uses a simple swab to collect a saliva sample just from the inside of the cheek. The test strip is deliberately simple in design and engineered to keep plastic usage to a minimum – with none of the plastic casing present that is usually associated with lateral flow tests.
The Intelligent Fingerprinting COVID-19 test’s easy saliva sample collection makes it particularly suitable for testing more vulnerable people and children. It facilitates frequent testing across a range of applications including schools, workplaces, public events, care homes, healthcare, airports and prisons. Test results are available in 20 minutes – a third quicker than most current nose and throat lateral flow tests.
“Almost everyone who has taken a nose or throat swab to test for COVID-19 knows just how unpleasant they can be. It is important to make COVID-19 testing as easy and comfortable as possible, particularly as frequent and simplified testing will continue to play a key role in the global response to the pandemic. In developing our new COVID-19 saliva test, we have successfully combined the benefits of much simpler sample collection with high levels of accuracy using our existing technology,” explained Intelligent Fingerprinting’s Executive Chairman Philip Hand.
“The introduction of our new COVID-19 test involved rapid design, development and manufacture within the UK over a ten-month period. Manufacturing capacity at our Cambridge plant, utilising existing equipment and ISO 13485 quality control, is ready to support the production of millions of tests per month, and we also anticipate we will be working with existing and new distribution partners to make this test available across multiple markets,” he added. “At Intelligent Fingerprinting we continue to demonstrate our ability to develop entirely new lateral flow testing concepts, in addition to our unique fingerprint-based drug tests that are sold within the UK, US and other international markets.”
Intelligent Fingerprinting VSS-GP test for rapid detection of SARS-CoV-2 antigen
Intelligent Fingerprinting’s VSS-GP is a lateral flow test to detect the SARS-CoV-2 antigen using a saliva sample, with results in 20 minutes. Through independent evaluation, the test has demonstrated 100% sensitivity in testing 150 positive clinical samples (Ct range 18.0 to 28.0), and 100% specificity following tests with 250 RT-PCR confirmed negative clinical saliva samples. The company is finalising the Technical File for applying the CE mark on the product under the In Vitro Diagnostics Directive, while also planning to transition to the In Vitro Diagnostics Regulation for European CE marking for professional and self-test use. The test comprises a four-part kit with 50 single-use COPAN CE-marked swabs for saliva collection, 50 single-use plastic collection tubes with lids, and 50 single-use VSS-GP SARS-CoV2 test strips, along with a dropper bottle containing the reagent buffer.
How it works
A swab is used to collect the saliva sample from the inside of the lower cheek, which is then mixed with a reagent buffer that has been pre-added to the collection tube in order to release the virus. The screening test is performed by inserting the tip of the VSS-GP test strip into the sample, providing a positive or negative result at 20 minutes. No instrumentation is required. The test uses gold immunonanoparticle technology to enable the visual detection of bound antigen via a control line and a red line on the test strip when a saliva sample is positive for the SARS-CoV-2 antigen.
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About Intelligent Fingerprinting:
Intelligent Fingerprinting is a leading provider of fast and cost-effective point-of-care diagnostic solutions – including a portable Drug Screening System that works by analysing fingerprint sweat. The company has distributors across the globe, including the USA. Founded in 2007, Intelligent Fingerprinting is a spin-out company from the University of East Anglia (UEA). The company is based in Cambridge, England and employs around 40 people. www.intelligentfingerprinting.com Twitter @iFingerprinting