FDA Monitoring Impact of SARS-CoV-2 Mutations on Results of Authorized COVID-19 Molecular Tests
The US Food and Drug Administration (FDA; Silver Spring, MD, USA) has alerted clinical laboratory staff and health care providers that it is monitoring the potential impact of viral mutations, including an emerging variant from the UK known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests. More...11 Jan 2021
COVID-19 Test Chip Made by Aerosol Jet Nanoparticle 3D Printing Detects SARS-CoV-2 Antibodies in 10-12 Seconds
An advanced nanomaterial-based biosensing platform that detects antibodies specific to SARS-CoV-2 within seconds can also help to quantify patient immunological response to the new vaccines with precision. More...11 Jan 2021
Siemens IL-6 Test for COVID-19 Response Granted FDA Emergency Use Authorization
Siemens Healthineers (Erlangen, Germany) has been granted an Emergency Use Authorization by the US Food and Drug Administration for its laboratory-based IL-6 assay to measure the presence of interleukin-6 in human serum or plasma. More...08 Jan 2021
NIH Develops Robust SARS-CoV-2 Serology ELISAs from Serum and Dried Blood Microsamples
In order to achieve the high levels of specificity and sensitivity needed for its "serosurvey" to track undetected cases of COVID-19 in the US, researchers at the National Institutes of Health (NIH Bethesda, MA, USA) have developed two assays to detect the spike protein and receptor binding protein, achieving sensitivity of 100% (95% CI 76.8%, 100%), and specificity of 100% (95% CI 96.4%, 100%). More...08 Jan 2021
New COVID-19 Rapid Antigen Test Can Be Run on Mobile Testing Platform for Lab-Quality Test Results in 15 Minutes
A new COVID-19 rapid antigen test that provides lab-quality test results in 15 minutes could offer a frequent, fast, cheap and easy COVID-19 screening solution to help meet the surging demand for tests and relieve the global supply chain. More...08 Jan 2021
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