- Reliable and accurate test will provide unequivocal results in 1 minute, compared to rapid antigen tests (30 minutes)
- Designed to be used at schools, events, companies, hotels, or airports, where swift diagnosis matter.
- Reliable and easy-to-use, for the qualitative detection of specific antigens of SARS-CoV-2 present in the human saliva, nasal or nasopharynx
- Will immediately identify potentially contagious individuals infected by SARS-CoV-2
- A point-of care COVID-19 antibody panel is in development (5 minutes to results) to identify immunized patients and guide physicians with the vaccination strategy.
Biopôle, Lausanne, Switzerland, November 30, 2021 – Abionic SA, a developer of disruptive nanotechnology-based diagnostic solutions, has announced CE Mark (Conformité Européenne) of a new 1-minute COVID-19 saliva test using its cutting-edge testing platform, abioSCOPE. This milestone allows Abionic to commercialize its ultra-fast test for identifying individuals infected by SARS-CoV-2 throughout the European Union. Designed to be used at schools, events, companies, hotels, or airports, where swift diagnosis is key, 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."
The IMD business school is currently trialling the saliva test on its Lausanne campus. Louis Leclézio, CDO IMD, commented: “We have an internationally mobile executive participant profile and student community. It has been priority for us to ensure our participants arrive and depart in full health. It is important to us that we continue to ensure a safe learning environment without interrupting their ability to learn at IMD. To manage this ever-changing process, we are trialling Abionic’s solution now because we want to have the ability to rapidly assess the Covid status of those who access our campus – and make decisions accordingly.”
Large-scale COVID-19 serology
The COVID-19 pandemic is yet again on the verge of escalating, despite a hopeful case decrease recorded during spring and summer 2021, due to successful vaccination rollouts. Together with the emergence of new variants, the potential waning of vaccine immunity could pose threats to public health. Therefore, many countries are considering the introduction of antibody tests for COVID-19. These are tests to establish whether an individual has built up antibodies to the virus, which might protect them against re-infection and enable them to work and travel without restrictions.
Abionic is announcing the development of a rapid (5 minutes), simple (from a drop of capillary blood) and quantitative (determination of the antibody level) serological test quantifying both IgG nucleo- and spike proteins.
This quantitative serology panel is planned to be CE marked in Q2 2022, by the time current studies have determined the level of antibody required for immunity. A rapid test using capillary blood simplifies the patient's journey and allows for a single appointment/passage to a screening and vaccination center (prevention center). In addition, this test that will be used on the abioSCOPE platform will allow for a personalization of the vaccination and not a population-based vaccination. Abionic’s antibody panel will directly contribute to maximizing the general immunity, leading to a lower burden on healthcare system.
“The major advantage of Abionic's solution is to be able to perform, within a few minutes, directly on site a serology, unlike laboratory tests which take more than 24 hours to obtain results and require a second appointment.” stated Dr. Alessandro Diana, Medical Director of the Qorpus Hirlsanden Medical Center Geneva, and expert vaccinologist at Infovac. “This simplification is, in our opinion, the key to facilitating and obtaining collective immunity more quickly and ensuring that the population adheres to the vaccination.”
Founded in 2010, Abionic is a Swiss Medtech company commercializing in 25+ countries a revolutionary nanofluidic technology, providing healthcare professionals with a fast, simple and universal diagnostic tool. Abionic’s cutting-edge Nanotechnology enhances efficiency and versatility of standard ELISA tests to deliver optimal point of care (POC) treatment options with the ability to reduce the current biological techniques from macroscale to nanoscale in a multi-analyte environment. Abionic’s In Vitro Diagnostic (IVD) platform provides lab-quality ultra-fast results from a single drop of patient sample (saliva, blood, urine, etc.) at the POC enabling personalized diagnostics and the possibility of immediate treatment initiation. The company is mainly active in acute care (early identification of sepsis, COVID-19 severity) and in primary care (allergy, iron deficiency) businesses.