September 2, 2020 - Roche (Basel, Switzerland) announced it will launch a SARS-CoV-2 Rapid Antigen Test in late September for markets accepting the CE Mark. Roche also intends to file for Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA). The SARS-CoV-2 Rapid Antigen Test is for use in point-of-care (POC) settings for both … [Read more...]
Abbott releases fast, $5 COVID-19 antigen test, free mobile app to display test results
August 27, 2020 - Abbott (Abbott Park, IL) has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its BinaxNOW COVID-19 Ag Card rapid test for detection of COVID-19 infection. The company says it will sell this test for $5. Currently, AdvaMed (The Advanced Medical Technology Association) estimates that test manufacturers are … [Read more...]
CMS Updates Reporting, Testing Requirements for Labs, Healthcare Providers
August 26, 2020 - The Centers for Medicare & Medicaid Services (CMS) announced sweeping regulatory changes that require labs and other healthcare providers to test staff and offer testing to residents for COVID-19. Labs and nursing homes using point-of-care (POC) testing devices will be required to report diagnostic test results as required by the CARES Act (Coronavirus … [Read more...]
Quidel to update packaging of POC Sofia SARS Antigen test for COVID-19 to include either nasal or nasopharyngeal swabs
August 20, 2020 - Quidel Corporation announecd that labeling for Quidel’s Emergency Use Authorization (EUA) for the Sofia SARS Antigen FIA has been amended to include either nasal or nasopharyngeal swabs. The new kit labeling, with the addition of a nasopharyngeal swab, allows Quidel to offer a second kit configuration to support the nasopharyngeal sample … [Read more...]
BD Veritor System for COVID-19 testing now available
From the upcoming September edition of Repertoire Magazine. August 20, 2020 - Designed to meet the evolving and critical needs of point-of-care (POC) testing, the BD Veritor Plus system enables you to streamline the testing experience. Be ready for flu season by testing with CLIA-waived Flu A+B, Group A Strep, and respiratory syncytial virus (RSV) assays along with the … [Read more...]
Sekisui Diagnostics announces FDA clearance, CLIA Waiver of OSOM Ultra Plus Flu A&B Test
Sekisui Diagnostics announced it received FDA clearance and CLIA Waiver of the OSOM Ultra Plus Flu A&B Test intended for the qualitative detection of influenza type A and type B nucleoprotein antigens directly from nasal or nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. According tot he company, the test utilizes … [Read more...]