The cobas SARS-CoV-2 Test is now authorised for testing samples from people without symptoms or other reasons to suspect Covid-19
Roche has received the US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) for its cobas SARS-CoV-2 Test for use in people without Covid-19 symptoms.
The cobas SARS-CoV-2 Test is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2.
It runs on the company’s high-throughput cobas 6800/8800 Systems and uses nasal, nasopharyngeal, and oropharyngeal swab specimens collected from any individuals.
The fully automated cobas 6800/8800 Systems provide rapid results with high throughput and long walk-away time among automated molecular platforms, said the company.
Roche diagnostics solutions molecular lab head Cindy Perettie said: “One of the key strategies to reduce COVID-19 transmission is to stop the silent spread of disease early.
“Expanding highly sensitive testing to include people who are at risk of exposure but do not show symptoms will help guide contact tracing, isolation and surveillance requirements, which are crucial for public health and the safe reopening of communities.”
The test is intended for use only under EUA in Clinical Laboratory Improvement Amendments (CLIA) certified laboratories.
Also, it is intended for testing pooled samples containing up to and including six individual samples from self-collected nasal swab specimens, or nasal, nasopharyngeal, and oropharyngeal swab specimens collected by healthcare provider.
The current FDA authorisation supports the updated US Centres for Disease Control and Prevention (CDC) guidance to expand SARS-CoV-2 testing.
According to a CDC study, individuals who do not exhibit Covid-19 symptoms are responsible for the transmission of more than half of all infected cases.
The study underlines that symptom-based testing alone is not adequate to effectively control the spread of Covid-19, and presents a significant public health challenge.
Roche said that asymptomatic testing using its cobas SARS-CoV-2 Test will be available in countries accepting the CE mark.