The new test enables the qualitative detection of the nucleocapsid protein of SARS-CoV-2 present in human nasal specimens
Roche branch offices in Basel. (Credit: F. Hoffmann-La Roche Ltd)
Roche has secured CE mark approval for its new SARS-CoV-2 Rapid Antigen Test Nasal, which enables self-collection of specimens by patients.
The company will start supplying the new test in countries accepting the CE mark by mid-February.
Roche has collaborated with SD Biosensor to launch the new SARS-CoV-2 Rapid Antigen Test Nasal. SD Biosensor is currently under preparations to submit an emergency use authorisation (EUA) to the US Food and Drug Administration (FDA).
Roche and SD Biosensor have already launched a SARS-CoV-2 Rapid Antibody Test in July and a SARS-CoV-2 Rapid Antigen Test in September 2020.
The SARS-CoV-2 Rapid Antigen Test Nasal is a rapid chromatographic immunoassay designed to facilitate the qualitative detection of the nucleocapsid protein of SARS-CoV-2 present in human nasal specimens.
Compared to the existing Roche SARS-CoV-2 Rapid Antigen Test, the new test gathers the sample from the front area of the nose rather than nasopharynx.
The testing method will help minimise overall patient discomfort, specifically in sensitive individuals such as children, elderly people and people with disabilities.
Under the supervision of a healthcare professional, the patients are allowed to use the new test to self-collect their nasal sample.
According to the company, the SARS-CoV-2 Rapid Antigen Test Nasal demonstrated a relative sensitivity of 90.6% and a specificity of 98.6% for professionally collected samples.
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.”
In December 2020, Roche introduced its Elecsys SARS-CoV-2 antigen test in the CE mark accepting markets.
The Elecsys SARS-CoV-2 antigen test is a laboratory immunoassay for the in vitro qualitative detection of the nucleocapsid antigen of SARS‑CoV‑2.