Roche gets FDA okay for COVID-19 antibody test

Roche Diagnostics has received FDA Emergency use approval for its highly specific Elecsys antibody test.


The US Food and Drug Administration has granted Emergence use approval (EUA) to Roche Diagostics GmbH’s new Elecsys® Anti-SARS-CoV-2 antibody electrochemiluminescence test. The test, which targets the viral nucleocapsid protein, has a "sensational specifity" of 99.8%, said Roche CEO Severin Schwan.

The first three millions of tests produced at Roche’s Penzberg site, which saw an investment of €170m for expansion of the biochemicals production capacity before, will go to healthcare institutions within Germany, Roche Chairman Christoph Franz said on occcasion of the market launch. According to an agreement with German Health Minister Jens Spahn, Roche will deliver further 5 million tests per each of the following months. Franz said, Roche will invest further €250m to make the Penzberg site new research and development hub for diagnostic tests of Roche.

The new Elecsys® Anti-SARS-CoV-2 electrochemiluminescence test, which runs on Roche’s cobas e platform and related modules, detects antibodies to the ruthenylated nucleocapsid protein of SARS-CoV-2 with a test specificity of 99.8% and a sensitivity of 100% two weeks after PCR-confirmed infection with the new coronavirus, according to Roche. The specificity tested on 5,272 subjects indicates how often a test is negative, i.e. what proportion of negative cases is correctly identified. The sensitivity confirmed on only 29 patients indicates how many of the positive results are correct.

At the beginning of April, Germany’s clinical diagnostics association ALM had yet criticised that current antibody tests delivered too many false-positive results. The nine other antibody diagnostic tests with FDA EUA have either shown too low specificity or the sensivity.


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