The real-time PCR-based test is said to enable high-throughput reliable detection of early COVID-19 infections for rapid isolation and treatment guidance
Image showing ultrastructural morphology of coronaviruses. (Credit: CDC/ Alissa Eckert, MS; Dan Higgins, MAM/Wikipedia.)
Finnish molecular diagnostics firm Mobidiag has received emergency use authorization (EUA) for its Amplidiag COVID-19 molecular diagnostic test in Finland.
The test has been designed to facilitate the rapid detection of SARS-CoV-2 virus, which causes the novel coronavirus infection (COVID-19).
Mobidiag CEO Tuomas Tenkanen said: “At Mobidiag, we recognize that we have a responsibility to support healthcare systems during this extraordinary situation and we are focusing our efforts in this endeavour. There is an urgent and growing need for reliable diagnostic solutions for the early detection of COVID-19.
“Mobidiag has been able to leverage its capabilities and existing technologies to develop new diagnostic solutions quickly. We are extremely pleased to bring our first diagnostic solution to the main clinical laboratories in Finland for large volume screening of COVID-19 and look forward to offering tests internationally in due course.”
Mobidiag’s test works on Amplidiag platform to determine the SARS-CoV-2
Mobidiag’s new diagnostic test is intended for routine use at the prime clinical laboratories in Finland, to double the testing capacity in Finland.
The company is looking to register the test for CE-IVD mark and make it available for widespread use in Europe in the coming weeks.
The new COVID-19 assay facilitates qualitative determination of SARS-CoV-2 from the nasopharyngeal swabs.
Designed to run on the company’s Amplidiag Easy platform, the test provides clinicians an optimized sample screening process with automated DNA extraction and PCR plate setup.
The Amplidiag COVID-19 test has been developed based on well-established high-throughput PCR technology, and can process 48 samples in less than three hours, said the company.
The test is currently being commercialised in Finland as an emergency use test. The company has also applied for emergency use authorisation of the test in Sweden, UK and France.
Furthermore, Mobidiag is developing Novodiag COVID-19, a molecular diagnostic test leveraging its Novodiag system for the rapid detection of SARS-CoV-2, and complement its Amplidiag COVID-19 test.
The company is developing the new Novodiag assay in partnership with Autobio Diagnostics and Automobi Molecular Diagnostics.