Opti Medical Systems Inc has received the CE mark certification in the European Union for its Opti SARS-CoV-2 RT-PCR laboratory test kit for the detection of SARS-CoV-2, the virus that causes COVID-19. This announcement follows earlier validation of the test by the Institut Pasteur of France as well as Emergency Use Authorization (EUA) by the US FDA.
Additionally, the FDA has granted EUA for the new Opti DNA/RNA Magnetic Bead Kit for nucleic acid extraction from respiratory samples to be used with the Opti SARS-CoV-2 RT-PCR test kit, which enables OPTI Medical Systems to provide laboratories with a complete Opti Medical Systems-manufactured workflow solution for COVID-19 testing.
“With the Opti SARS-CoV-2 RT-PCR test kit, we benefit from an optimized workflow and a test that has proven to deliver the quality and accuracy that I would expect from a COVID-19 test. Combined with the OPTI DNA/RNA Magnetic Bead Kit, we now have all reagents needed for a complete solution for our COVID-19 PCR testing needs,” said Dr. Hayley Webber, Technical Director, Molecular Diagnostics at NorDx Laboratories of Scarborough, Maine.
The Opti SARS-CoV-2 RT-PCR test kit uses real-time reverse transcription polymerase chain reaction (RT-PCR) technology and is designed to provide results in approximately 2–3.5 hours.
“The CE mark certification is an important step in advancing our efforts to support critical COVID-19 testing. We are committed to helping our communities around the globe and will continue to work with regulatory authorities and customers to expand the availability of diagnostic testing,” said Olivier te Boekhorst, Corporate Vice President and General Manager of Opti Medical Systems.