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- Ortho s VITROS® SARS-CoV-2 Antigen Test is the first high-volume COVID-19 antigen test to receive Food and Drug Administration (FDA) Emergency Use Authorization (EUA).
- With utility for mass-scale testing and same-day results for labs, Ortho s latest COVID-19 solution can run up to 130 tests per hour.
- The test is run on Ortho s high-volume VITROS® Systems, which are installed in over 5,600 laboratories around the world with 1,500 installed in the U.S.
RARITAN, N.J., Jan. 12, 2021 /PRNewswire/ Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced that its VITROS
® SARS-CoV-2 Antigen Test, designed to detect active infection, has become the first high-volume COVID-19 antigen test to receive U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA). U.S. distribution of the test commenced in November 2020 under an FDA Emergency Use Notification (EUN); the test was also granted CE Mark
Ortho s VITROS SARS-CoV-2 Antigen Test for Accurate, Mass-Scale COVID-19 Testing is the First High-Volume Test to Receive FDA Emergency Use Authorization
i, clinically reliable results on Ortho s high-volume VITROS Systems, which are installed in over 5,600 laboratories around the world. More than 1,500 VITROS analyzers are operational across the U.S. - including more than 500 located in rural regions, where coronavirus testing needs are especially urgent.
These analyzers normally run a broad menu of over 150 different tests from blood and body fluid samples, but now are also able to run samples derived from swabs. Additional analyzers are available for shipment and can be installed rapidly to further increase capacity since they don t require an external water source to operate.
Abbott Announces Fulfillment of Federal Government Purchase of 150 Million BinaxNOW COVID-19 Rapid Tests and Is Now Ready to Support Commercial Distribution
Abbott is announcing today the fulfillment of the federal government’s order of 150 million BinaxNOW ™ COVID-19 Ag tests. These rapid tests were distributed through the Department of Health and Human Services to states, territories and targeted entities, such as nursing homes, assisted living facilities, home health and hospice agencies, historically black colleges and universities and the Indian Health Service. …
– Abbott (NYSE: ABT) is announcing today the fulfillment of the federal government’s order of 150 million BinaxNOW ™ COVID-19 Ag tests. These rapid tests were distributed through the Department of Health and Human Services (HHS) to states, territories and targeted entities, such as nursing homes, assisted living facilities, home health and hospice agencies, historically black colleges and universities
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- Early and Cost-Effective Identification of Samples Potentially Containing the B.1.1.7 or Other Variants May Help Reduce Further Spread of Infection -
Applied DNA Sciences, Inc. (NASDAQ: APDN) (the Company ), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, announced today that the U.S. Food and Drug Administration (FDA) published a safety communication (the Communication ) that identifies the Company s Linea COVID-19 Assay Kit (the Assay Kit ) as one of only two tests marketed under the FDA s Emergency Use Authorization (EUA) that are potentially able to identify certain SARS-CoV-2 mutations, including a mutation found in the U.K. variant of SARS-CoV-2 (B.1.1.7). According to recent publications, the B.1.1.7 variant has been identified within the United States and may be associated with an increased risk of transmission of the virus that causes COVID-19. The identification of certain mutations can help identify samples that should be further characteriz
Applied DNA Sciences : U S FDA Lists Applied DNA s Linea™ COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U K Variant (B 1 1 7) marketscreener.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from marketscreener.com Daily Mail and Mail on Sunday newspapers.