NEW YORK – Eurofins Technologies said on Monday that its GSD NovaGen SARS-CoV-2 rapid antigen test has received CE marking.
The test provides results in 15 minutes from nasopharyngeal samples and has a sensitivity of nearly 93 percent and specificity of nearly 99 percent, the company said in a statement.
The Budapest-based firm also said its GSD NovaPrime SARS-CoV-2 PCR test, which received CE marking in May, has been validated for pharynx gargling samples. The multiplex test detects two target sequences in the N gene of the virus and provides results in a about an hour, the company said. More than 5 million of the tests have been performed since its launch in May, Eurofins added.
The company said it intends to file for Emergency Use Authorization from the US Food and Drug Administration for the antigen test and the new modality for the PCR test.