COVID-19 cheek swab test receives CE mark


Intelligent Fingerprinting’s saliva-based COVID-19 test is now CE marked. The new VSS-GP COVID-19 saliva test uses a swab to collect saliva 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 common COVID-19 testing in a range of applications including schools, workplaces, public events such as as sports or concerts, nursing homes, healthcare, airports and prisons.

The VSS-GP COVID-19 test strip has been designed to use minimal plastic. It doesn’t have any of the plastic housings usually associated with lateral flow testing, which helps reduce its environmental impact. The test strip is approximately 95% lighter than traditional lateral flow devices.

Intelligent Fingerprinting Executive Chairman Philip Hand said, “Regular COVID-19 testing will continue to be a part of our daily lives for the foreseeable future, so it is essential that we remove potential barriers to testing and deliver the the whole process as easy and comfortable as possible. . Our saliva-based test responds directly to this challenge, combining much simpler sample collection with high levels of precision. I am delighted that our test is now CE marked and we anticipate a strong demand for saliva-based tests from markets around the world.

“We have already increased production capacity at our Cambridge, UK manufacturing facility using existing equipment, implemented ISO 13485 quality control and given initial demand and distribution agreements, we will be able to produce our new COVID-19 tests based on saliva. at a rate of four million per month by the end of 2021. We also plan to work with a range of channel partners to make this test available in multiple markets.

Intelligent Fingerprinting VSS-GP Lateral Flow Saliva Test Clinical Precision testing yielded 100% sensitivity and specificity (n = 400 results) using RT-PCR verified samples containing samples SARS-CoV-2 virus (lowest viral titer Ct 28.5). CE marking was obtained under the directive on in vitro diagnostics. The saliva-based test was developed in the UK by Cambridge-based Intelligent Fingerprinting, developers and manufacturers of the world’s first and only sweat fingerprint test. The new COVID-19 test is developed from the company’s expertise in lateral flow technology.

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 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 within 20 minutes. No instrumentation is required. The test uses gold immunonanoparticle technology to allow 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- antigen. 2.

Source link


Leave A Reply