Roche SARS-CoV-2 Rapid Antigen Test receives special approval for at-home patient self-testing using nasal swabs in Germany

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Roche announced it has been granted special approval by the German Federal Institute for Drugs and Medical Devices (BfArM) to offer the SARS-CoV-2 Rapid Antigen Test using a simple nasal swab for patient self-testing in Germany.

The test is a reliable rapid test for the qualitative detection of a specific SARS-CoV-2 antigen in nasal swab samples.This rapid antigen test collects the sample from the front area of the nose instead of the nasopharynx, resulting in a simplified and more comfortable sampling procedure. By following simple instructions, patients can perform the test at home with results ready after only 15 minutes. The test will be made available in pharmacies and requires no prescription.

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,” said Thomas Schinecker, CEO Roche Diagnostics. “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.”

This test is part of a partnership with SD Biosensor Inc., with whom Roche has also launched a SARS-CoV-2 Rapid Antibody Test in July and two SARS-CoV-2 Rapid Antigen Tests for professional use in September 2020 and February 2021. Those tests will continue to play an important role in this pandemic and remain available for healthcare professional testing.

Roche continues to expand its comprehensive COVID-19 portfolio to support healthcare systems in diagnosing SARS-CoV-2 infection.

About the SARS-CoV-2 Rapid Antigen Test for at-home patient self-testing
The SARS-CoV-2 Rapid Antigen Test for self testing is a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 present in human nasal specimens. In a self-testing clinical study, the SARS-CoV-2 Rapid Antigen Test showed a sensitivity of 82.5% and a specificity of 100.0% when compared to RT-PCR testing. The relative sensitivity was 91.2% for samples with a high viral load ( Ct ≤30). Patients suspected of COVID-19 followed written and illustrated instructions to sample and test themselves1. Most study participants considered the procedures easy to perform.

About antigen testing
An antigen test detects proteins which are structural or functional components of a pathogen and are very specific to that pathogen2. In this case, the test would provide a qualitative “yes/no” answer on the presence of the antigen in the patient sample and can be offered as a rapid strip test that is performed at the point of care. If the target antigen (nucleocapsid protein) is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a visually detectable signal on the test strip, typically with results ready in 15 minutes. A rapid antigen test can reliably detect individuals with a high viral load allowing healthcare professionals to quickly identify those patients at the greatest risk of spreading the infection.