NEW YORK ─ Point-of-care test developer Abionic said this week that it has obtained the CE mark for its IVD Capsule COVID-19 antigen test, enabling its use in the European Union and other regions that accept the designation.
The Lausanne, Switzerland-based firm said its saliva-based antigen test detects the SARS-CoV-2 nucleoprotein and provides results in one minute.
In clinical studies that included 119 people, the antigen test demonstrated "very high sensitivity for identifying infectious persons with viral loads measured by PCR" at cycle thresholds less than 27, the firm said in a statement.
To operate the test, the user mixes saliva with a reagent and dispenses the mixture onto the IVD Capsule, which is then loaded onto a reading device that is part of a testing platform called abioScope.
Abionic has developed the test for numerous settings, including schools, events, hotels, restaurants, and airports.
The company said it is developing a version that uses nasal and nasopharyngeal swabs for testing in hospitals, clinics, private physician practices, and pharmacies.
Abionic noted it is also developing a serology test to provide results in five minutes from capillary blood and quantify IgG levels of the SARS-CoV-2 nucleoprotein and spike protein.