US Food and Drug Administration (FDA) has awarded an Emergency Use Authorization (EUA) to Siemens Healthineers for its laboratory-based total antibody test for the SARS-CoV-2 antibodies. The company stated that data from the test showed 100% sensitivity and 99.8% specificity. Testing can commence immediately and over one million tests are already provided to health systems and laboratories.
Longhorn Vaccines & Diagnostics and Cenetron Diagnostics have partnered with Southeastern Container (SEC) for the expansion of their Covid-19 testing kits production. Under the collaboration, Cenetron and other medical product manufacturers will produce Covid-19 test kits using Longhorn’s PrimeStore Molecular Transport Medium (MTM) and SEC-sourced preform Coca-Cola bottles as test tubes. The companies aim to produce one to two million preform test tubes each week to address the testing goal of US to carry out ten million tests each week.
The FDA has modified the guidance regarding hand sanitisers and has provided additional clarification on the manufacture and compounding of some hand sanitiser products that are alcohol-based. This is expected to increase the supply of hand sanitisers in the country during the Covid-19 pandemic and help in ensuring that harmful levels of impurities are not present in the ethanol that is used in hand sanitiser.
Hoowaki has introduced a one-piece injection-moulded design for a Covid-19 swab to address the gap in the US and worldwide testing supplies for Covid-19. The company modified its Hoowaki Microgrip surface technology to produce micro-pillars used in the Hoowaki NP Collection Swab. This has demonstrated that it meets the current industry-standard products with regard to flexibility and performance.