Roche obtains CE mark for the SARS-CoV-2 Antigen Self-Test Nasal

Roche obtains CE mark for the SARS-CoV-2 Antigen Self-Test Nasal

The Roche SARS-CoV-2 Antigen Self-Test Nasal.

ROCHE has received the CE mark for its SARS-CoV-2 Antigen Self-Test Nasal for at-home testing. The test will be available in countries accepting the CE mark, including Ireland, through pharmacies and other locations, in packs of five tests.

Finbarr Kenny, Director of Ireland, Roche Diagnostics said: “Our new nasal antigen self-test provides results in 15 minutes and has the added advantage of only requiring a sample from the lower part of both nostrils - making it relatively easy and less uncomfortable to perform.

“The clinical performance of the test was measured by head-to-head comparison with our PCR test.

“With sensitivity between 86 and 91%, the self-test provides a quick and reliable result indicating if a person is currently infectious with Covid-19.

“As we navigate the careful road to recovery from this pandemic, PCR and rapid antigen (lateral flow) testing for Covid-19 can both play a critical role in helping to allow normal activities to resume safely and with confidence.”

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.

“With the CE Mark, the SARS-CoV-2 Antigen Self-Test Nasal for rapid self-testing of Covid-19 test has received official approval following the traditional registration pathway and can now also be used in markets that have not established regulatory exemption pathways.

“By following simple instructions, individuals can perform the test at home using a nasal swab without special training or the supervision of a healthcare worker.

“The test provides results in as little as 15 minutes and can help people to conveniently check if they are likely to be infectious from the comfort of their home.

“In the case of children under 18 years of age, the test must be performed by an adult or under close adult supervision.

“As societies begin to reopen, and in line with local health regulations, the convenient test allows individuals planning to attend an event or gathering to use the test as a tool to confirm that they are not likely to be carriers of a substantial amount of the virus thus helping them make informed decisions and reduce the risk of transmission to 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 2020 and two SARS-CoV-2 Rapid Antigen Tests for professional use in September 2020 and February 2021.

These tests will continue to play an important role in fighting this pandemic and remain available for healthcare professional testing.

In addition to diagnostic testing, preventive measures remain key to protecting yourself and others against SARS-CoV-2.

It is recommended to continue wearing masks, socially distance, and practice good hygiene, especially if you have symptoms or known contact with others who have tested positive for the virus.

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

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.

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.

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