TGA approves Atomo's rapid antigen COVID-19 test

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Atomo Diagnostics (ASX:AT1) has announced that the Australian TGA has approved its rapid COVID-19 rapid antigen blood test for use by medical professionals.

The company said the approval means it has the ability to provide both COVID-19 antigen and antibody rapid tests in Australia. The company’s COVID-19 antibody test was approved by the Australian regulator in August.

“Atomo can now offer rapid testing for both COVID-19 antigen and antibody responses in a single 15-minute window. This comprehensive rapid screen will help determine acute active infection and also indicate those people who may have had prior exposure to the virus and built up an antibody response,” saidAtomo co-founder and managing director John Kelly.

The rapid antigen test is a nasopharyngeal swab test designed to screen for antigens produced in response to acute COVID-19 infection and a positive result implies current viral infection.

The rapid antibody test identifies whether a person has developed antibodies in response to the virus and is most accurate after 15 days post-exposure.

The combination of the two tests could potentially aid with public policy responses to the virus through the deployment of greater levels of screening as communities come out of lockdown.

The Atomo test has the advantage of being processed internally at the point of care with a result available after 10 minutes. Antigen testing may have benefits for early identification and the control of outbreaks in some situations.

Mr Kelly added,“ Up to 20% of infections are asymptomatic and this has led to many countries now establishing regular, proactive testing regimes. Antigen tests have been proven to provide good detection of COVID-19 infection in the early stages of exposure, We believe this makes them useful both for people showing the onset of symptoms or for broad-scale screening of at-risk communities and frontline workers.

"Furthermore, Atomo believes that when combined with our rapid antibody test that detects the antibody response to virus exposure over a longer period, they should offer excellent performance where reliable testing is most convenient and needed – outside of the laboratory.

"Atomo would like to see rapid testing widely deployed to speed up a return to some sort of ‘COVID Normal’ environment – that goes for frontline workers and their families, people who need to travel, as well as the broader community. Rapid testing is an increasingly vital and in the case of Australia currently underutilised tool in the toolkit and we believe now is the time to look to deploy it.”