The company is also offering the test for asymptomatic testing in countries accepting the CE mark
Roche has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its cobas SARS-CoV-2 Test for asymptomatic people.
The test, which is designed for use on cobas 6800/8800 systems, will help in the assessment of individuals without symptoms or reasons to suspect Covid-19.
Roche is also offering the cobas SARS-CoV-2 Test for asymptomatic testing in countries accepting the CE mark.
The FDA’s authorisation will allow the real-time RT-PCR test to be used for the qualitative detection of nucleic acids from SARS-CoV-2 in healthcare provider-instructed self-collected anterior nasal (nasal) swab specimens (collected on site).
According to the company, it is also used to test healthcare provider-collected nasal, nasopharyngeal and oropharyngeal swab specimens collected from any individuals, including those suspected of Covid-19 by their healthcare provider and those without symptoms or other reasons to suspect Covid-19.
Roche’s test will also facilitate the qualitative detection of nucleic acids from SARS-CoV-2 in pooled samples.
The pooled samples may contain up to six individual samples collected from healthcare provider-instructed self-collected nasal swab specimens or healthcare provider-collected nasal, nasopharyngeal, and oropharyngeal swab specimens.
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.”
In December last year, Roche introduced Elecsys SARS-CoV-2 antigen test in the CE mark accepting markets.
The Elecsys test facilitates the detection of SARS-CoV-2 present in the respiratory tract including nasopharynx and oropharynx.