A study has shown that Avacta Group’s AffiDX antigen lateral flow test detects the Delta variant of the SARS-CoV-2 virus in clinical samples and, in this small study, outperformed two lateral flow antigen tests that are commercially available in Europe.
Lateral flow antigen tests are intended to provide a cost effective and rapid means of identifying individuals with a high viral load that means they are more likely to infect others. The clinical data for Avacta’s AffiDX SARS-CoV-2 antigen lateral flow test demonstrated 100% sensitivity for identifying infectious individuals with viral loads measured by PCR of Ct<27, which is considered infectious.
The SARS-CoV-2 virus, like most viruses, mutates over time to create different variants and those that have a biological advantage will become a dominant strain. The Delta variant, first identified in India, has recently emerged, has greater infectivity, and may rapidly become a dominant strain worldwide.
The AffiDX SARS-CoV-2 antigen lateral flow test has been evaluated with a small number of patient samples confirmed to be Delta variant positive and, for a Ct<29, the test was shown to correctly identify all the positive cases. In this study, two other commercially available lateral flow tests were evaluated: One test detected half the positive cases and the other detected none.
The AffiDX SARS-CoV-2 antigen lateral flow test is CE marked for professional use in the UK and EU. The company has recently appointed the first distributor for the test, Calibre Scientific, and is progressing multiple commercial opportunities with other distributors and professional end users in Europe and the UK.
Dr Alastair Smith, chief executive officer of Avacta Group, said: “We are delighted to report that the AffiDX SARS-CoV-2 antigen lateral flow test detects the Delta variant with very high sensitivity for patients with a Ct value of less than 29. This is a variant of the virus that is spreading rapidly on a global scale and therefore the ability of the test to detect this variant is paramount to our commercial roll-out.
“In comparison with other lateral flow tests on the market, Avacta’s rapid antigen test demonstrates better clinical performance. This is a further huge validation of the Affimer reagent platform for use in in-vitro diagnostics.
“This excellent performance and ease of nasal sampling, coupled with the fact that the AffiDX test has been developed in the UK, is based on UK technology and is manufactured in the UK are huge selling points for customers in Europe.”
