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15th April 2020  Content supplied by: Mobidiag Oy (HQ)

Mobidiag Receive EUA in Finland For High-Throughput AmplidiagĀ® COVID-19 qPCR Test


Mobidiag has received emergency use authorization (EUA) in Finland for its Amplidiag® COVID-19 molecular diagnostic test for the rapid detection of the SARS-CoV-2 virus.

The test will be run for routine use at the main clinical laboratories in Finland (Helsinki University Hospital (Huslab), SYNLAB and Mehiläinen) doubling Finnish testing capacity and allowing testing coverage for most of the country.

The process for obtaining emergency use authorization is now ongoing in Sweden, UK and France.

Mobidiag will register this test for CE-IVD mark, and it should be available for widespread use in Europe in the coming weeks. 

The Amplidiag COVID-19 assay allows qualitative determination of SARS-CoV-2 (orf1ab and N genes) from nasopharyngeal swabs.

The test runs on Mobidiag’s Amplidiag Easy platform, which enables to clinicians an optimized sample screening process with automated DNA extraction and PCR plate setup. Based on well-established high-throughput PCR technology, it can process 48 samples in less than three hours.

In addition, Mobidiag is developing Novodiag® COVID-19, a molecular diagnostic test using its Novodiag system for the rapid and on-demand detection of SARS-CoV-2. This test will complement Amplidiag® COVID-19 in enabling clinicians around the world to detect COVID-19 infections early, support decisions in managing efficiently epidemiological and infection control measures, isolate patients in a timely manner and improve patient care. 


    

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Date Published: 15th April 2020

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