The German Federal Institute for Drugs and Medical Devices (BfArM) has granted special approval to Roche’s SARS-CoV-2 Rapid Antigen Test using a simple nasal swab for patient self-testing in the country.
The rapid chromatographic immunoassay is for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 in human nasal swab samples collected from the front area of the nose instead of the nasopharynx.
It demonstrated 82.5% sensitivity and 100% specificity versus RT-PCR testing in a self-testing clinical study.
Furthermore, the test showed a relative sensitivity of 91.2% for samples with a high viral load (Ct ≤30).
The test can be obtained at pharmacies without needing a prescription and carried out at home. It provides results in just 15 minutes.
Roche Diagnostics CEO Thomas Schinecker said: “The German Federal Institute for Drugs and Medical Devices’ special approval of our test provides people in Germany with a reliable option to test themselves in the comfort of their own home.
“Regular self-testing at home can reduce pressure on healthcare systems.
“It can quickly identify people with the highest potential to be infectious so they can take immediate action to manage their infection, seek medical advice, and protect others.”
The test is part of Roche’s collaboration with global in-vitro diagnostic company SD Biosensor.
The companies have unveiled a SARS-CoV-2 Rapid Antibody Test last July and two SARS-CoV-2 Rapid Antigen Tests for professional use in September last year and last month respectively. The tests will be available for healthcare professional testing.
An antigen test identifies proteins that are the pathogen’s structural or functional components and are very specific to that pathogen.
It can detect people with high viral load. In this way, healthcare workers can quickly recognise those who are at a high risk of spreading the infection.
Last September, the cobas SARS-CoV-2 & Influenza A/B Test developed by Roche for use on the cobas 6800/8800 Systems received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA).