NEW YORK – Roche announced on Friday that its SARS-CoV-2 Rapid Antigen Test has received special approval for at-home self-testing in Germany.
The German Federal Institute for Drugs and Medical Devices approved the test for patient self-testing at home for use with a nasal swab. The test returns results in 15 minutes and will be available at German pharmacies with no prescription, the company said in a statement.
The test, developed in partnership with SD Biosensor, is a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2. In a self-testing clinical study, the test had a sensitivity of nearly 83 percent and a specificity of 100 percent when compared to RT-PCR testing, Roche said. Relative sensitivity was 91 percent for samples with a high viral load, it added.
Roche's rapid antigen test for use with nasal swabs received CE marking for use earlier this month and its antigen test for use with nasopharyngeal swabs received CE marking in September. Last week, the rapid test received approval from Health Canada under an interim order. It is currently under evaluation with the US Food and Drug Administration for Emergency Use Authorization, according to a Roche spokesperson.