Despite numerous reports of false-negatives from rapid antigen-based COVID-19 test kits, Avacta and Cytiva (formerly GE Healthcare Life Sciences) have developed a kit they plan to sell to the general public. Avacta have given Medusa19, exclusive rights to global sales and marketing of the kit and non-exclusive rights for its distribution.

Medusa19 is a new company set-up by Mahmud Kamani and Richard Hughes, both co-founders of boohoo.com, a popular fashion retail outlet, aimed at the 16-30-year-olds.

The Affimer^® rapid test, being created by Avacta and its partners Cytiva, who are now part of the Danaher Group, is intended to enable an individual with the COVID-19 infection, whether they have symptoms or not, to be identified before the body has generated antibodies. Avacta claims the Affimer® proteins are highly specific and bind to the 'spike proteins' on the surface of SARS-COV-2. 

According to the WHO, the antigen(s) detected, in this case, the spike protein, are expressed only when the virus is actively replicating; therefore, such tests are best used to identify acute or early infection.

In the absence of independent validation, the WHO has advised against the use of rapid diagnostic tests based on antigen detection in any setting (except research settings), including for decision-making, until evidence supporting their use for specific indications is available. However, due to the overall benefits an accurate test could bring, WHO are 'highly encouraging' research into their performance. 

But in comparison with similar tests used for influenza, the WHO state sensitivity can vary between 34% and 80%.

There are only a few rapid antigen tests with CE-marking on the market but no independent validation exists on these kits.