Intelligent Fingerprinting’s saliva-based COVID-19 test now carries CE marking. The new VSS-GP COVID-19 Saliva Test uses a swab to collect saliva from just inside the cheek, providing an alternative to current throat and nose tests.
Intelligent Fingerprinting’s reliable and easy-to-use saliva-based lateral flow test supports frequent COVID-19 testing across a range of applications, including schools, workplaces, public events such as sports or concerts, care homes, healthcare, airports and prisons.
The VSS-GP COVID-19 test strip has been designed to use minimal plastic. It has none of the plastic housing usually associated with lateral flow tests, helping to reduce its environmental impact. The test strip is around 95% lighter than traditional lateral flow devices.
Intelligent Fingerprinting’s executive chairman, Philip Hand said: “Regular COVID-19 testing will continue to be part of our everyday lives for the foreseeable future, so it’s essential that we remove potential barriers to testing and make the whole process as simple and comfortable as possible. Our saliva-based test directly addresses this challenge, combining much simpler sample collection with high levels of accuracy. I’m delighted that our test is now CE marked, and we anticipate strong demand for saliva-based testing from markets around the world.
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“We have already scaled up production capacity at our Cambridge, UK, manufacturing facility utilising existing equipment, have ISO 13485 quality control in place and given initial demand and distributor agreements, we will be able to produce our new saliva-based COVID-19 tests at a rate of four million a month by the end of 2021. We also anticipate working with a range of distribution partners to make this test available across multiple markets.”
Clinical precision testing of Intelligent Fingerprinting’s VSS-GP lateral flow saliva test has resulted in 100% sensitivity and specificity (n = 400 results) using RT-PCR verified samples containing SARS-CoV-2 virus samples (lowest viral titre Ct 28.5). CE marking has been achieved under the In Vitro Diagnostics Directive. The saliva-based test has been developed in the UK by Cambridge-based Intelligent Fingerprinting, developers and manufacturers of the world’s first and only fingerprint sweat drug test. The new COVID-19 test is developed from the company’s lateral flow technology expertise.
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 to release the virus into the solution. The screening test is performed by inserting the tip of the VSS-GP test strip into the sample, providing a positive or negative result in 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.