The special approval from German Federal Institute for Drugs and Medical Devices (BfArM) allows at-home self testing of SARS-CoV-2 using nasal swabs
Roche has secured a special approval from Germany’s Federal Institute for Drugs and Medical Devices (BfArM) for its SARS-CoV-2 Rapid Antigen Test for patient self-testing using nasal swab samples.
The test is designed to provide rapid and qualitative detection of a specific SARS-CoV-2 antigen in nasal swab samples, collected from the front area of the nose.
Unlike the nasopharyngeal swabs, which collect samples from nasopharynx, nasal swab samples offer a simplified and more comfortable sampling procedure, said the company.
Roche intends to commercialise the product as a no-prescription test through pharmacies.
Patients can use the rapid antigen test at home with simple instructions, and get the test results within 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 current SARS-CoV-2 Rapid Antigen Test for self-testing is a rapid chromatographic immunoassay, designed for the qualitative detection of the SARS-CoV-2 nucleocapsid.
Roche claimed that its new test has demonstrated 82.5% sensitivity and 100% specificity compared to RT-PCR testing, in a self-testing clinical study.
The test showed a relative sensitivity of 91.2% for samples with a high viral load.
In the study, patients suspected of Covid-19 were given illustrated written instructions to self-collect the sample and self-test themselves, which were easy to perform for most of them.
The company has developed the test under the partnership with SD Biosensor, an in-vitro diagnostic company focused on immunoassay and molecular diagnostic products.
Together with SD Biosensor, it has also launched a SARS-CoV-2 Rapid Antibody Test in July 2020, and two SARS-CoV-2 Rapid Antigen Tests in September 2020 and February 2021 respectively, for professional use.