Eurofins Technologies announces the launch of two important products to support the fight against COVID-19:

• a CE-IVD labelled 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 especially beneficial in the testing of children.

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. Since the launch of the product in May, more than five million tests have been performed on validated sample types.  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.

These two kits can also be purchased online by appropriately licensed practitioners at the Eurofins Technologies webshop and are for use only where officially authorized in Europe. Eurofins Technologies intends to separately file FDA EUA applications for the new testing modalities.