Roche, Basel, Switzerland, 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 mid-February 2021.
In comparison to the existing 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. This testing method can help reduce overall patient discomfort, particularly in sensitive individuals such as children, elderly people, 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. Through reduced physical contact, this method of testing can help to decrease the risk of exposure to the virus for healthcare professionals. Whether the test could also be used without supervision of a healthcare professional will depend on local regulatory requirements.
“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.” says Thomas Schinecker, CEO Roche Diagnostics. “The SARS-CoV-2 Rapid Antigen Test Nasal provides patients with a more comfortable testing experience.”
The launch is a partnership with South Korea-based SD Biosensor, 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 was preparing to submit an emergency use authorization (EUA) to the FDA.
The test is the latest addition to Roche’s comprehensive covid-19 portfolio to support healthcare systems in diagnosing SARS-CoV-2 infection.
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 is intended to detect antigen from SARS‑CoV‑2 in individuals suspected of covid‑19 or with known or suspected exposure to SARS‑CoV‑2.
This product is intended for professional use in laboratory and point-of-care environments, and/or self-collection under the close supervision of a healthcare worker.