Novacyt is ready to introduce two PathFlow COVID-19 antigen lateral flow tests (LFTs) to bolster its Covid-19 portfolio and seek fresh market opportunities, particularly in point-of-care (POC) settings.
Developed in collaboration with an undisclosed partner through an original equipment manufacturer (OEM) agreement with Novacyt’s Microgen Bioproducts division, PathFlow COVID-19 Rapid Antigen Pro and PathFlow COVID-19 Rapid Antigen are small, instrument-free tests.
A CE-marked test, PathFlow COVID-19 Rapid Antigen Pro is indicated to identify SARS-CoV-2 antigens from anterior nasal or nasopharyngeal samples, with results delivered in nearly 15 minutes.
Meant for professional usage, the test showed a 93.5% sensitivity and 99.3% specificity when using nasal swab samples. With nasopharyngeal swab samples, the sensitivity and specificity were 93.4% and 99.4%, respectively.
The PathFlow COVID-19 Rapid Antigen test identifies SARS-CoV-2 antigens using oral fluid specimens and also delivers results in about 15 minutes.
As a self-test, this test can be used for mass screening in at-home settings as well as for travel, events and workplace testing. It demonstrated 90.1% sensitivity and 99.3% specificity.
Both tests come with all the constituents needed for obtaining a sample as well as its preparation, testing and results interpretation. The tests also have a disposal kit for appropriate use by healthcare workers or patients at home.
In the initial stage, Novacyt will target private markets and supply the tests using its current distribution network.
Novacyt CEO Graham Mullis said: “These two antigen LFTs will support our customers as the market continues to evolve towards private testing and we believe they will become a useful entry point to our existing range of PCR Covid-19 tests.
“With the potential for a flu season starting in the northern hemisphere in a few months it will be important to know whether a person has flu or SARS-CoV-2 and having access to quick results are critical to patient treatment and containing the spread of the Covid-19 virus.”
The test’s performance was observed as better than two lateral flow antigen tests commercially available in Europe, Avacta noted.
It had a sensitivity of 100% in detecting infectious people with viral loads of cycle threshold (Ct) less than 27.
In March, Avacta confirmed that its AffiDX SARS-CoV-2 rapid antigen LFT can detect the dominant new variants of the coronavirus as well as the original strain.