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Eurofins Technologies Gets CE-IVD Mark for Multiplex Coronavirus Test

NEW YORK — Eurofins Technologies said on Thursday that it has received CE-IVD marking for the GSD NovaPrime SARS-CoV-2 (COVID-19) test.

The multiplex RT-PCR test simultaneously detects two target sequences inside the SARS-CoV-2 N gene, providing results in about two hours, according to the company.

According to Budapest-based Eurofins Technologies, a subsidiary of Eurofins Scientific, the test demonstrated 100 percent negative and positive percent agreement for all tested samples and shown no cross-reactivity with other common widely spread coronaviruses. The analytic sensitivity shows a limit of detection of 3.75 copies per reaction.

The test was developed in collaboration with Eurofins Scientific subsidiaries Gold Standard Diagnostics, Virotech Diagnostics, and NovaTec Immundiagnostica.

Last month, Eurofins Technologies received CE-IVD marking for three ELISA-based tests for SARS-CoV-2.