DetectaChem has announced that its MobileDetect Bio (MD-Bio) BCC19 Covid-19 test kit has received Emergency Use Authorisation from the US Food and Drug Administration (FDA). The BCC19 test kit makes use of portable laboratory-grade diagnostic technology that can operate up to 96 tests in each device in just 30 minutes. The test detects nucleic acids from the 2019-nCoV virus to determine positive or negative results and then makes use of the free MobileDetect App for Apple and Android platforms to produce result reports with time, date, images, patient info, GPS mapping and more.
BreviTest Technologies announced that the US FDA has allowed the commercial distribution of its IgG antibody test. The BreviTest SARS-CoV-2 IgG Test identifies the presence of SARS-CoV-2 specific IgG antibodies in plasma or serum using only 3μl of sample. Results are produced in ten minutes.
OraSure Technologies has announced that its ORAcollect·RNA (OR-100) collection device has been included along with other devices in the US FDA EUA granted to Los Angeles-based molecular genetics company MiraDx. This is the fifth EUA to include a collection device from the company’s DNA Genotek subsidiary.
Fujifilm Sonosite, a provider of point-of-care ultrasound (POCUS) solutions, has received 510(k) approval from the US FDA for its complete POCUS portfolio to support healthcare providers in carrying out lung and cardiac imaging in patients suffering with Covid-19. Meanwhile, Fujifilm Sonosite has also released a comprehensive user guide intended to aid healthcare professionals on how to best use POCUS technology to correctly interpret ultrasound images to identify the most typical Covid-19 findings relating to lung and cardiac conditions.