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February 2, 2021updated 21 Oct 2021 11:45am

Roche obtains CE Mark for SARS-CoV-2 Rapid Antigen Test Nasal

Swiss healthcare company Roche has secured the CE Mark for its new SARS-CoV-2 Rapid Antigen Test Nasal, a test kit for Covid-19.

Swiss healthcare company Roche has secured the CE Mark for its new SARS-CoV-2 Rapid Antigen Test Nasal, a test kit for Covid-19.

Roche plans to make the test available in countries that accept the CE mark by the middle of this month.

When compared to its previous product Roche SARS-CoV-2 Rapid Antigen Test, the new SARS-CoV-2 Rapid Antigen Test Nasal will collect the sample from the front area of the nose instead of the nasopharynx, making it a simple and fast testing method.

As a less invasive test, it can also be used by patients self-collecting the nasal sample under the supervision of a healthcare professional. It can further reduce the risk of virus exposure for healthcare professionals.

The SARS-CoV-2 Rapid Antigen Test Nasal is a rapid chromatographic immunoassay to detect the nucleocapsid protein from the SARS-CoV-2 virus in the human nasal specimens.

Roche’s clinical studies claim that the test had a relative sensitivity of 90.6% and a specificity of 98.6% for professionally collected samples, and in self-collected samples, the sensitivity was recorded at 84.4 % with a specificity of 99.2%.

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Roche Diagnostics CEO Thomas Schinecker said: “Rapid testing continues to play an important role in the fight against Covid-19, especially in places when laboratory testing is not available and quick results are needed, such as nursing homes, healthcare facilities, and schools.

“The SARS-CoV-2 Rapid Antigen Test Nasal provides patients with a more comfortable testing experience.”

The new test is being launched by Roche, in partnership with SD Biosensor, a company with which it had previously launched a SARS-CoV-2 Rapid Antibody Test in July and a SARS-CoV-2 Rapid Antigen Test in September.

Meanwhile, Ellume, a digital diagnostics firm, had signed a $231.8m agreement with the US Department of Defense (DoD), in coordination with the Department of Health and Human Services (HHS), to speed up the production of its Covid-19 home tests.

Authorised by the US Food and Drug Administration (FDA), Ellume COVID-19 Home Test is a rapid self-test and can be used in both asymptomatic and symptomatic cases.

The agreement includes funding to support Ellume in establishing a manufacturing facility in the US and to deliver 8.5 million of the tests to be distributed across the country.

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