Roche granted CE mark for its SARS-CoV-2 Antigen Self Test Nasal for rapid at-home testing

Roche has been granted a CE mark for its SARS-CoV-2 Antigen Self Test Nasal for rapid at-home testing.

About the SARS-CoV-2 Antigen Self Test Nasal
  • The test enables individuals to quickly and conveniently test themselves for COVID-19 at home using a simple nasal swab.
  • An early version of the test has already been available as a home-test in a number of European markets under local special approval pathways since February 2021
  • The test will be widely available to individuals through pharmacies and other locations in accordance to local guidelines and testing strategies
  • The test works seamlessly with NAVIFY® Pass, Roche’s digital solution that allows individuals and healthcare providers to immediately store, display, and share their COVID-19 test results and vaccine status through a unique QR code.

By following simple instructions, the test can be performed at home using a nasal swab without special training or the supervision of a healthcare worker. It provides results in as little as 15 minutes. It can help people to conveniently check if they are likely to be infectious, from the comfort of their home. For anyone under 18 years of age, the test must be performed by an adult or under close adult supervision.

What type of test is it?

The SARS-CoV-2 Rapid Antigen Self Test Nasal is a rapid chromatographic immunoassay (lateral flow assay) for the detection of the nucleocapsid protein of SARS-CoV-2 in human nasal samples.

What is the sensitivity and specificty of the test?

The clinical performance of the test was measured by head to head comparison with Roche’s highly sensitive reverse transcriptase polymerase chain reaction (RT-PCR) test using nasopharyngeal swab samples as a comparator, the gold standard sampling and detection method for SARS-CoV-2 detection. Combined study results showed that the relative sensitivity of the SARS-CoV-2 Antigen Self Test Nasal was 91.1%. The overall relative specificity was 99.6%, which represents the ability of the test to correctly identify patients without the virus.

Sources:

Roche website

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