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8th June 2021  Product update: rapidvirology staff writer

Large Manufacturer Receives CE-Marking For SARS-CoV-2 Antigen Self-Test


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

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 has received official approval following the traditional registration pathway and can now also be used in markets that have not been 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 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. 

Complementary to the SARS-CoV-2 Antigen Self Test Nasal, Roche is offering NAVIFY® Pass. This digital solution allows individuals and healthcare professionals to remotely store, display, and share their COVID-19 test results and vaccine status through a personalized QR code. Having easy digital access to test results and vaccination status could potentially be used by both individuals and companies to facilitate access to locations with COVID-19 entry protocols, such as restaurants or entertainment venues, as well as to validate safety to travel.

“As the world prepares to reopen, high-quality, home-based testing will play an important role in the battle against the pandemic,” 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 seek medical advice, manage their infection, 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 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. 

The SARS-CoV-2 Antigen Self Test Nasal for At-Home Patient Self-Testing

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. Each test contains a unique QR code to enable individuals to share their test results and vaccine status using NAVIFY Pass, Roche’s digital solution. For more information on NAVIFY Pass, click here

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 %,3 which represents the ability of the test to correctly identify patients without the virus. In one comparative independent self-testing study where patients followed written and illustrated instructions to sample, test and read out the results themselves, the majority of study participants considered the procedures easy to perform. 


    

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Date Published: 8th June 2021

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Note: This content has been edited by a rapidvirology.com staff writer for style and content.


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