PerkinElmer's Euroimmun SARS-CoV-2 Test Secures FDA Emergency User Authorization

(Waltham, MA; USA) has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for EUROIMMUN’s (a PerkinElmer company) EuroRealTime SARS-CoV-2 molecular assay COVID-19.

The CE-marked PCR-based test is designed for the specific detection of SARS-CoV-2 in a quick and simple manner using reverse transcription and real-time PCR in a single step. It is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens, including nasal, nasopharyngeal, mid-turbinate, and oropharyngeal swabs, as well as bronchioalveolar lavage from patients who are suspected of having COVID-19. The EURORealTime test offers high sensitivity due to simultaneous detection of two SARS-CoV-2 target sequences.

“The EURORealTime SARS-CoV-2 was developed for specific detection of the new coronavirus. The test detects two different genetic sequences simultaneously and is therefore very sensitive,” said Dr. Ulf Steller, Head of the Division Molecular Genetic Diagnostics at EUROIMMUN AG.