COVID-19: Roche AG launches antigen rapid test
Roche said it would be able to produce 40 million tests monthly upon launch of a test that detects viral antigens within 15 minutes from pharengeal swabs and which thus would allow for rapid testing at the point of care. This capacity could be doubled until the end of the year to met global demand. Roche said the test will be rolled out in late September in the EU. Roche said it also intends to file for Emergency Use Authorisation (EUA) to the U.S. Food and Drug Administration (FDA), which has already given EUA to four similar antigen tests: from Abbott (sensitivity 97.1%, specifity 98.5%), Lumira Dx UK (sensitivity 99.3%, specifity 98.4%), Becton Dickinson (sensitivity 84%, specifity 100%), and Quidel Corp (sensitivity 96.7%, specifity 100%). Roche said, its test has a sensitivity of 96.52% and a specificity of 99.68%, based on 426 samples from two independent study centers.
The hope linked to viral antigen tests is that they can distinguish people carrying the SARS-CoV-2 virus from those who are not infected. In principle that is correct. However, there are some limitations one must be aware of. According to the FDA, virus antigen tests are generally less sensitive than RT-PCR tests used in laboratory diagnostics but significantly cheaper. In a mass testing scenario, there will be a lot of false test results, so it is nor a medical but a political question what is seen as an acceptable sensitivity. As results from rapid antigen tests generally differ from those of virus culture experiments because they can not distinguish between live or non-viable viruses, the diagnostics initiaive FIND has announced to carry out head-to-head testing of RT-PCR vs. viral antigen tests on several thousands of subjects. Results are yet to be published.
The global roll out of Biosensor SD Inc’s antigen test ou complements Roche's portfolio of marketed SARS-CoV-2 RT-PCR tests and antibody tests.