24th Feb

Roche Launches the SARS-CoV-2 Rapid Antigen Test Nasal

Rapid Antigen Test Nasal

Roche announced it has obtained the CE mark for its new SARS-CoV-2 Rapid Antigen Test Nasal. The test will be available in countries accepting the CE mark by end of February 2021.

The SARS-CoV-2 Rapid Antigen Test Nasal uses a nasal swab to collect specimens from people suspected of having an active infection. Nasal sampling allows for collection of the sample from the front area of the nose and is done as quick and as convenient as possible. 

The company’s test also provides patients with the option to self-collect their nasal sample.

 Roche SARS-CoV-2 Rapid Antigen Test, the SARS-CoV-2 Rapid Antigen Test Nasal collects the sample from the front area of the nose instead of the nasopharynx, resulting in a simplified and faster testing procedure. 

Roche’s testing method can diminish patient discomfort in sensitive individuals such as elderly people, children and/or people with disabilities.

Besides being less invasive, the test also provides patients with the option to self-collect their nasal sample under the supervision of a healthcare professional. This allows a reduced physical contact between the patient and the healthcare professional and decrease the risk of exposure. 

“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.” said Thomas Schinecker, CEO Roche Diagnostics. 

The launch is a partnership with SD Biosensor Inc., with whom Roche has also launched a SARS-CoV-2 Rapid Antibody Test in July and a SARS-CoV-2 Rapid Antigen Test in September 2020. SD Biosensor, is currently preparing to submit an Emergency Use Authorisation (EUA) to the U.S. Food and Drug Administration (FDA).

More about the SARS-CoV-2 Rapid Antigen Test Nasal

The SARS-CoV-2 Rapid Antigen Test Nasal is a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 present in human nasal specimens. In clinical studies, the SARS-CoV-2 Rapid Antigen Test Nasal showed a relative sensitivity of 90.6% (Ct value ≤ 30; 95 % CI: 75.0 % – 98.0 %) and a specificity of 98.6% for professionally collected samples. For self-collected samples a sensitivity of 84.4 % (Ct value ≤ 30; 95 % CI: 67.2 % – 94.7 %) and a specificity of 99.2% was detected. Overall the studies contained  468  symptomatic and asymptomatic individuals2. This test intents to detect antigen from SARS‑CoV‑2 in individuals suspected of COVID‑19 or with known or suspected exposure to SARS‑CoV‑2.

The product is for professional use in laboratory and Point of Care environments, and/or self-collection under the close supervision of a healthcare worker.

Antigen Testing

Proteins that are structural or functional components of a pathogen are identified by an antigen test and are thus very unique to that pathogen. In this case, the test will include a qualitative “yes/no” response to the presence of the pathogen in the sample of the patient and would be provided as a rapid strip test at the point of treatment.

If the target antigen is present in appropriate concentrations in the sample, the target antigen binds to specific antibodies and produces a visually identifiable signal on the test strip, with results usually ready within 15 minutes.

A rapid antigen test can diagnose people with a high viral load accurately, helping healthcare professionals to identify those patients with the greatest risk of transmitting the infection rapidly.

Read media release >> 

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