Coronavirus company news summary – New Covid-19 RNA test from the UK gives accurate results within minutes – Shuwen obtains CE-IVD mark for Covid-19 test kit

6 January 2021 (Last Updated January 6th, 2021 10:01)

Researchers from the UK University of Birmingham have developed a Covid-19 RNA test that can deliver accurate results within five minutes. The test uses an amplification technique called Exponential Amplification Reaction (EXPAR) which uses very short, single strands of DNA for the replication process, which can be completed in a matter of minutes.The entire test can be run on standard laboratory equipment at lower temperatures compared to PCR tests, which require higher temperatures to separate out strands of DNA as part of the amplification process.

Nirmidas Biotech has announced its second Emergency Use Authorization (EUA) approval from the US Food and Drug Administration (FDA) for its Covid-19 rapid antibody IgG/IgM test. The test is now available at point-of-care settings. The MidaSpot™ COVID-19 Antibody Combo Detection Kit uses a fingerstick serology test to detect antibodies against the receptor‐binding domain (RBD) antigen on the surface of the SARS-CoV-2 virus.

Trinity Biotech has achieved a CE mark for its Captia™ SARS-CoV-2 IgG ELISA antibody test. Trinity has launched the test across all European Union (EU) countries as well as other countries that approve the CE mark.

Shuwen Biotech has been granted the CE-IVD mark for its SARS-COV-2 RT-PCR Kit. The Chinese government agency has also granted the company clearance for exporting the kit. The kit is currently available in Europe for distribution and in other regions that recognise the CE certification.