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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.


    

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Date Published: 30th March 2020

Source article link: http://ir.perkinelmer.com/news-releases/news-release-details/fda-provides-emergency-use-authorization-perkinelmer-covid-19

Note: This content has been edited by a rapidmicrobiology staff writer for style and content.


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