New 1-Minute COVID-19 Saliva Test Enables Swift Diagnosis of SARS-CoV-2 Infection

Abionic SA (Lausanne, Switzerland) has obtained the CE Mark (Conformité Européenne) for its new 1-minute COVID-19 saliva test using its cutting-edge testing platform, abioSCOPE. This allows Abionic to commercialize its ultra-fast test for identifying individuals infected by SARS-CoV-2 throughout the European Union. The test could signal a renaissance for the beleaguered hospitality sector which has lost millions of euros as bars, hotels and restaurants have borne the brunt of the pandemic restrictions. Equally, it could allow schools to remain open, offering continuity in education, and allow airports to streamline the passenger experience, and encourage travelers to fly again.

The clinical data for the ultra-fast IVD CAPSULE COVID-19 antigen test is based on studies including 119 individuals and demonstrated very high sensitivity for identifying infectious persons with viral loads measured by PCR of Ct<27, which is considered infectious. The ultra-fast IVD CAPSULE COVID-19 test using a saliva sample has been compared to Cobas 6800 UNICOVID saliva RT-PCR and showed very good correspondence. The test detects the presence of the nucleoprotein inside the SARS-CoV-2 virus, and thus can be used for assessing the contagiousness of an individual.

The use of the system is simple: after collecting saliva, the user mixes it with the reagent to reveal the nucleoprotein. The mix is then dispensed onto the IVD CAPSULE which is loaded onto the abioSCOPE reading device tray. After approximately 1 minute, the result is obtained directly on the screen of the abioSCOPE. The result is unequivocal and can be automatically transferred via secured data transmission protocol using the integrated ethernet port of the abioSCOPE.

Abionic's 1-minute COVID-19 saliva antigen quantification test also provides information about the potential contagiousness of the patient, allowing for preventive decision making immediately: "Is the patient representing a risk of spreading the disease?". It is designed to be used at schools, events, companies, hotels, or airports, where swift decision-making on COVID status is critical. Abionic is also developing a nasal / nasopharyngeal version of the IVD CAPSULE: COVID-19 on-site antigen diagnostic tests will allow healthcare professionals to issue an official COVID passport or extension of the COVID pass. It is designed to be used at hospitals, clinics, private practices, or pharmacies, where immediate high-quality results are of importance. The company is now preparing the listing on the EU common list.

"We are happy to offer the right tools to ensure COVID-free environments," stated Dr. Nicolas Durand, CEO of Abionic. "Getting a result in 1 minute re-opens the doors of places that were until now closed to many individuals. Obtaining CE Mark for our Saliva COVID-19 IVD CAPSULE is an important step in providing access to highly accurate ultra-fast tests throughout the European Union, and beyond. We are proud to actively participate to the global effort to get back to normality."

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