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December 20, 2021updated 07 Jan 2022 8:48am

Roche gets CE mark for Covid-19 test with saliva samples

Individuals have the option to self-collect their saliva samples on site under healthcare providers guidance.

Roche has obtained CE mark for its cobas SARS-CoV-2 Qualitative test for the use of saliva samples to detect SARS-CoV-2.

The non-invasive test runs on the fully automated cobas 6800/8800 systems and is intended for use by both asymptomatic and symptomatic people.

It is a real-time RT-PCR test which is designed to detect nucleic acids from SARS-CoV-2 in nasal swab and saliva specimens.

Following a healthcare professionals’ instructions, individuals with or without symptoms have the option to self-collect their saliva samples on site.

According to the company, saliva sample collection is a non-invasive, easy, and convenient testing approach for patients to easily collect their own samples.

This sample collection method reduces physical contact and helps to decrease the exposure risk for healthcare professionals to the virus.

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Roche Diagnostics Solutions Molecular Labs head Cindy Perettie said: “One of the key strategies to reduce Covid-19 transmission is to stop the silent spread of the disease early.

“Expanding sensitive testing to include a non-invasive, easy-to-collect sample type such as saliva helps to improve access to screening for more people. This is crucial for public health and keeping our communities safe.”

The company stated that the cobas SARS-CoV-2 Qualitative test has already been available for use with nasopharyngeal, oropharyngeal swabs, and nasal samples collected by a healthcare professional.

In November this year, Roche introduced cobas 5800 system, a new molecular diagnostics system, in countries accepting the CE mark.

The new system delivers integration, automation consolidation and standardisation, and enables laboratories to consolidate more than 90% of testing on a single platform.

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