30th March 2020 Product update: PerkinElmer Inc.
FDA Provides EUA to PerkinElmer for COVID-19 Testing
PerkinElmer has announced that the U.S. Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for the Company’s New Coronavirus RT-PCR test. Clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) can immediately begin using this kit to detect SARS-CoV-2, the virus that causes COVID-19. PerkinElmer’s RT-PCR test is also CE-IVD marked, making it available in the European Economic Area (EEA).
The PerkinElmer New Coronavirus Nucleic Acid Detection Kit is a probe-based PCR assay using fluorescent-labeled probes specific to the 2019 coronavirus (SARS-CoV-2) open reading frame 1ab and nucleocapsid protein genes. It has a limit of detection (LoD) of 20 copies/mL using a 400 µL sample.
Date Published: 30th March 2020
Note: This content has been edited by a rapidmicrobiology staff writer for style and content.