Eurofins Launches Rapid SARS-CoV-2 Antigen Test and RT-PCR Test in Self-Sampled, Gargling Format

Eurofins Technologies (Budapest, Hungary) has launched a CE-IVD labeled rapid test for the detection of SARS-CoV-2 antigens in 15 minutes and a SARS-CoV-2 RT-PCR test that has been successfully validated for pharynx gargling samples, providing a gold standard PCR test in an easy-to-use, self-sampling format.

The GSD NovaGen SARS-CoV-2 (COVID-19) antigen rapid test provides results from nasopharyngeal samples within 15 minutes. With diagnostic sensitivity of 92.6% and diagnostic specificity of 98.6%, the test meets WHO performance criteria (sensitivity ≥80%; specificity ≥97%) for use in the global fight against COVID-19.

The GSD NovaPrime SARS-CoV-2 (COVID-19) is a highly sensitive Multiplex Real-Time PCR test for the direct qualitative pathogen detection of SARS-CoV-2. The assay simultaneously detects two target sequences in the N gene. The multiplex PCR test allows for a streamlined workflow in one reaction and provides results in approximately one hour.

The GSD NovaPrime SARS-CoV-2 (COVID-19) has now been successfully validated for pharynx gargling samples. In contrast to nasopharyngeal swabs, gargling is a non-invasive, easy-to-use sampling method that is less uncomfortable for the patient and particularly useful for self-sampling applications and the testing of children.