OpGen has announced that its subsidiary Curetis received CE mark certification for its SARS-CoV-2 Kit with PULB to detect the Covid-19-causing SARS-CoV-2 virus. The kit can be used with isolated RNA and with oropharyngeal or nasopharyngeal swabs that are collected in a viral transport medium, which is PCR-compatible and treated with PCR-Compatible Universal Lysis Buffer (PULB).
Trinity Biotech has submitted a request for an Emergency Use Authorization (EUA) to the US Food and Drug Administration for the Covid-19 IgG ELISA antibody test. The test will be used to identify patients who have been exposed to the novel coronavirus. It has shown more than 98% specificity and more than 95% sensitivity, in samples of 14 days since symptoms started.
LumiraDx has received emergency use authorization (EUA) for its LumiraDx SARS-CoV-2 antigen test from the US Food and Drug Administration (FDA) to address the need for fast and cost-efficient Covid-19 tests. The antigen nucleocapsid protein is identified by the test from a nasal swab and provides results within 12 minutes from sample application.
The United States Patent and Trademark Office has issued increased patent protection for Co-Diagnostics’ novel CoPrimer technology, which is used in its Covid-19 test kit and other molecular diagnostic tests. The original patent was received on 18 October 2018, and covered some applications of the CoPrimer molecule and its use in PCR. However, the patent did not include the molecule. This addition covers the physical structure of the molecule as well as the all molecular configurations.