Avacta Group, the developer of Affime biotherapeutics and reagents, will launch an ELISA laboratory test for the SARS-CoV-2 spike protein to support global research efforts into the coronavirus that causes COVID-19.
Enzyme linked immunosorbent assays - known as ELISAs - are common research tools used to detect and quantify a target in a wide range of samples.
Using the same Affimer reagents that are incorporated into its rapid coronavirus saliva test being developed with Cytiva, Avacta has developed in-house a high performance ELISA laboratory test to detect the SARS-CoV-2 virus.
Avacta will make the ELISA test available as a kit so that researchers globally can use it in their own laboratories to support research into the coronavirus.
The Affimer-based ELISA test is capable of detecting the coronavirus spike protein in laboratory samples down to very low concentrations.
An evaluation of the ELISA carried out with The Liverpool School of Tropical Medicine using SARS-CoV-2 virus samples shows that it can detect as little as a few thousand virus infectious units per millilitre of sample.
This is typical of the levels found in infectious COVID-19 patients' saliva whether they are symptomatic or not. Highly infectious COVID-19 patients can have many thousands or millions of times more spike protein in their saliva than this.
The Affimer-based ELISA test is also highly specific to the SARS-CoV-2 virus with no cross-reactivity against other closely related coronavirus spike proteins.
Avacta plans to supply the SARS-CoV-2 spike protein ELISA reagent kit directly and is also in active discussions with potential OEM partners and distributors globally.
Dr. Alastair Smith, Chief Executive of Avacta Group commented: "I am delighted with the outstanding performance of the Affimer-based ELISA test developed in-house by Avacta and that we will shortly make this powerful laboratory research tool available to support global research efforts to study the virus and develop ways to combat the pandemic.
"Avacta remains focused on the much larger opportunity of the saliva-based coronavirus antigen rapid test that we are developing with Cytiva and which is now in the process of technology transfer to our manufacturing partners.
"The excellent analytical performance of the ELISA test is very encouraging with regards to the anticipated clinical performance of the rapid test and I look forward to starting the clinical validation with the first pilot batch of rapid tests as soon as possible."