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16th March 2020  Product update: Paul Carton

Thermo Fisher's Taqman COVID-19 Diagnostic Kit Receives FDA Emergency Use Authorization


Thermo Fisher Scientific has announced that the US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for its diagnostic test that can be used immediately by CLIA high-complexity laboratories in the US to detect nucleic acid from SARS-CoV-2; the virus that causes COVID-19, and not for any other viruses or pathogens.

The authorized test uses Applied Biosystems™ TaqPath™ Assay technology and is designed to provide patient results within four hours of a sample being received by a lab. The estimated time-to-result also includes time for sample preparation and instrument analysis. 

The COVID-19 assays are designed to work with total nucleic acid that is isolated from samples collected via nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage (BAL). 

The EUA test is optimized for use on the company's Applied Biosystems 7500 Fast Dx Real-time PCR instrument, which is covered under the EUA and already used in clinical laboratories worldwide.

This FDA-EUA approved kit has three targets in the SARS-CoV-2 virus; ORF1ab, S protein and N protein. Each of the assays is to be run in duplex with the RNase P assay as an internal positive control.  


    

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Date Published: 16th March 2020

Source article link: http://thermofisher.mediaroom.com/2020-03-13-FDA-Issues-Emergency-Use-Authorization-to-Thermo-Fisher-Scientific-for-Diagnostic-Test-Used-to-Detect-COVID-19

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


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